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idarubicin

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Description

Idarubicin is an anthracycline antibiotic that is used as a chemotherapy agent to treat various cancers, including acute myeloid leukemia, breast cancer, and lymphoma. It works by interfering with DNA replication and cell division. Idarubicin is synthesized through a multi-step process starting from daunorubicin, another anthracycline antibiotic. It exerts its effects by binding to DNA, inhibiting topoisomerase II enzyme activity, and generating reactive oxygen species. Idarubicin's effectiveness in treating certain cancers, particularly acute myeloid leukemia, makes it a crucial therapeutic agent. Research focuses on understanding its mechanisms of action, optimizing its dosage and administration, and investigating its potential synergistic effects with other therapies. The study of idarubicin is crucial for developing novel anticancer strategies and improving patient outcomes.'
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Idarubicin: An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID42890
CHEMBL ID1117
CHEBI ID42068
SCHEMBL ID3750
MeSH IDM0023493

Synonyms (109)

Synonym
CHEMBL1117
AB00698511-09
AB00698511-08
BRD-K69650333-001-01-1
EU-0100600
idarubicin hydrochloride, solid
idarubicina [inn-spanish]
idarubicine [inn-french]
nsc 256439
idarubicina
daunomycin, 4-demethoxy-
idarubicinum [inn-latin]
5,12-naphthacenedione, 7,8,9,10-tetrahydro-9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-6,9,11-trihydroxy-, (7s-cis)-
idarubicin [inn:ban]
ccris 5083
4-desmethoxydaunorubicin
LOPAC0_000600
idarubicin
4-dmd
nsc256439
(7s,9s)-9-acetyl-7-[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-dione
5,12-naphthacenedione, 7,8,9,10-tetrahydro-9-acetyl-7-((3-amino-2,3,6-trideoxy-.alpha.-l-lyxo-hexopyranosyl)oxy)-6,9,11-trihydroxy-, (7s-cis)-
MLS001401448 ,
DM5 ,
4-demethoxydaunomycin
5,12-naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-, (7s-cis)-
smr000466355
CHEBI:42068 ,
(1s,3s)-3-acetyl-3,5,12-trihydroxy-6,11-dioxo-1,2,3,4,6,11-hexahydronaphthacen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
(1s,3s)-3-acetyl-3,5,12-trihydroxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
58957-92-9
4-demethoxydaunorubicin
DB01177
KBIOSS_002388
NCGC00093976-01
NCGC00093976-03
NCGC00093976-02
4 desmethoxydaunorubicin
4 demethoxydaunorubicin
I 1656 ,
HMS2089D05
NCGC00093976-04
(7s,9s)-9-acetyl-7-[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-dione
idarubicin (inn)
D08062
zavedos (tn)
A832088
(7s,9s)-7-[(2r,4s,5s,6s)-4-azanyl-6-methyl-5-oxidanyl-oxan-2-yl]oxy-9-ethanoyl-6,9,11-tris(oxidanyl)-8,10-dihydro-7h-tetracene-5,12-dione
(7s,9s)-9-acetyl-7-[[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyl-2-oxanyl]oxy]-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-dione
NCGC00093976-05
sr-01000075934
HMS3261H22
CCG-204689
BCP9000773
idarubicine
unii-zrp63d75jw
idarubicinum
zrp63d75jw ,
BCPP000207
LP00600
5,12-naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-.alpha.-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-, (7s,9s)-
idarubicin [vandf]
(1s,3s)-3-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-.alpha.-l-lyxo-hexopyranoside
idarubicin [inn]
idarubicin [who-dd]
idarubicin [mi]
AKOS015895563
gtpl7083
(7s,9s)-9-acetyl-7-{[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy}-6,9,11-trihydroxy-5,7,8,9,10,12-hexahydrotetracene-5,12-dione
AB00698511-10
AB00698511-06
SCHEMBL3750
tox21_500600
NCGC00261285-01
idarubicinhydrochloride
4-dmdr
XDXDZDZNSLXDNA-TZNDIEGXSA-N
(7s,9s)-9-acetyl-7-[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-quinone;hydrochloride
(7s,9s)-7-[(2r,4s,5s,6s)-4-azanyl-6-methyl-5-oxidanyl-oxan-2-yl]oxy-9-ethanoyl-6,9,11-tris(oxidanyl)-8,10-dihydro-7h-tetracene-5,12-dione;hydrochloride
(7s,9s)-9-acetyl-7-[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-dione;hydrochloride
bdbm58490
cid_636362
(7s,9s)-9-acetyl-7-[[(2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyl-2-oxanyl]oxy]-6,9,11-trihydroxy-8,10-dihydro-7h-tetracene-5,12-dione;hydrochloride
AB00698511_11
DTXSID7023142 ,
AC-9384
SR-01000075934-1
idarubicin, united states pharmacopeia (usp) reference standard
(7s,9s)-9-acetyl-7-((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy)-6,9,11-trihydroxy-7,8,9,10-tetrahydrotetracene-5,12-dione
4-demethoxy-daunorubicin
Q1063862
BRD-K69650333-003-14-0
BRD-K69650333-001-02-9
SDCCGSBI-0050582.P002
NCGC00093976-18
A935911
(7s,9s)-9-acetyl-7-(((2r,4s,5s,6s)-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yl)oxy)-6,9,11-trihydroxy-7,8,9,10-tetrahydrotetracene-5,12-dione
HY-17381A
CS-0007534
5,12-naphthacenedione, 9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-, (7s,9s)-
l01db06
idarubicinum (inn-latin)
(1s,3s)-3-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranoside
idarubicine (inn-french)
(1s,3s)-3-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-alpha-l-hexopyranoside
dtxcid503142
(7s-cis)-9-acetyl-7-((3-amino-2,3,6-trideoxy-alpha-l-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,9,11-trihydroxy-5,12-naphthacenedione
idarubicina (inn-spanish)
EN300-7479233

Research Excerpts

Overview

Idrubicin (IDA) is an antineoplasic drug commonly used to treat hematologic diseases. Idarubic in (IDR) is a chemotherapy drug classified as an anthracycline antitumor.

ExcerptReferenceRelevance
"Idarubicin (IDA) is an anthracycline antibiotic, frequently used for the treatment of various human cancers. "( Idarubicin-induced oxidative stress and apoptosis in cardiomyocytes: An
Gu, Z; Huang, P; Li, Q; Li, T; Ren, L; Xu, D; Zhang, Y, 2021
)
3.51
"Idarubicin (IDA) is an antineoplasic drug commonly used to treat hematologic diseases. "( Stability of a high-concentrated aqueous solution of idarubicin stored in a polypropylene syringe for transarterial chemoembolization.
Bourcier, B; Lagarce, F; Lebreton, V, 2022
)
2.41
"Idarubicin (IDR) is a chemotherapy drug that is classified as an anthracycline antitumor."( Apoferritin nanocages for targeted delivery of idarubicin against breast cancer cells.
Mansouri, K; Mousavi, A; Rafipour, R, 2022
)
1.7
"Idarubicin is an anthracycline antileukemic agent widely used in the treatment of hematological malignancies. "( Dexrazoxane Averts Idarubicin-Evoked Genomic Damage by Regulating Gene Expression Profiling Associated With the DNA Damage-Signaling Pathway in BALB/c Mice.
Ahmad, SF; Al-Hamamah, MA; Alshahrani, AY; Ansari, MA; Attia, MM; Attia, SM; Bakheet, SA; Nadeem, A; Saquib, Q, 2017
)
2.23
"Idarubicin (IDR) is a potent chemotherapeutic agent used to treat variety of cancers."( Structural investigation of idarubicin-DNA interaction: spectroscopic and molecular docking study.
Charak, S; Mehrotra, R, 2013
)
1.41
"Idarubicin (IDR) is an anthracycline compound that is used therapeutically for certain types of tumour."( Idarubicin is a broad-spectrum enterovirus replication inhibitor that selectively targets the virus internal ribosomal entry site.
Hou, HY; Kung, SH; Lin, CW; Lu, WW; Wu, KY, 2016
)
2.6
"Idarubicin is a clinically effective synthetic anthracycline analog used in the treatment of several human neoplasms. "( Bioreduction of idarubicin and formation of ROS responsible for DNA cleavage by NADPH-cytochrome P450 reductase and its potential role in the antitumor effect.
Arinç, E; Celik, H, 2008
)
2.13
"Idarubicin is a relatively hydrophobic member of the anthracycline family."( The encapsulation of idarubicin within liposomes using the novel EDTA ion gradient method ensures improved drug retention in vitro and in vivo.
Chwastek, G; Grynkiewicz, G; Gubernator, J; Korycińska, M; Kozubek, A; Lewrick, F; Stasiuk, M; Süss, R, 2010
)
1.4
"Idarubicin is a synthetic anthracycline anticancer drug widely used in the treatment of some hematological malignancies. "( Evaluation of the protective effects of quercetin, rutin, naringenin, resveratrol and trolox against idarubicin-induced DNA damage.
Arinç, E; Celik, H, 2010
)
2.02
"Idarubicin is an anthracycline antibiotic used in cancer therapy. "( A comparison of the in vitro genotoxicity of anticancer drugs idarubicin and mitoxantrone.
Błasiak, J; Gloc, E; Warszawski, M, 2002
)
2
"Idarubicin is an anthracycline antibiotic extensively used in acute leukemia. "( Protective role of antioxidant vitamin E and catechin on idarubicin-induced cardiotoxicity in rats.
Ates, A; Candan, S; Kalender, S; Kalender, Y; Olcay, E; Yel, M, 2002
)
2
"Idarubicin (IDA) is a member of an important class of anticancer agents, the anthracycline antibiotics. "( Caffeine enhances myocardial uptake of idarubicin but reverses its negative inotropic effect.
Kang, W; Weiss, M, 2003
)
2.03
"Idarubicin is an active agent in breast cancer and is suitable for dose escalation."( High-dose consolidation chemotherapy with Idarubicin and alkylating agents following induction with gemcitabine-epirubicin-paclitaxel in metastatic breast cancer: a dose finding study.
Bengala, C; Biadi, O; Conte, PF; Danesi, R; Del Tacca, M; Donati, S; Favre, C; Fogli, S; Guarneri, V; Innocenti, F; Mariani, M; Pazzagli, I, 2003
)
1.3
"Idarubicin (IDA) is a 4-demethoxy-anthracycline analogue of daunorubicin (DNR). "( Activation of caspases-3/7 is dispensable for idarubicin-induced apoptotic DNA fragmentation in human leukemia cells.
Qi, SN; Ueda, T; Yoshida, A, 2003
)
2.02
"Idarubicin (IDA) is an anthracycline anticancer drug utilized in the treatment of acute leukemias. "( Modulation of resistance to idarubicin by the cyclosporin PSC 833 (valspodar) in multidrug-resistant cells.
Duran, GE; Lacayo, NJ; Sikic, BI,
)
1.87
"Idarubicin (IDA) is a structural analogue of daunorubicin with the same mechanism of action. "( New oral drugs in older patients: a review of idarubicin in elderly patients.
Crivellari, D; Lombardi, D; Spazzapan, S; Toffoli, G; Veronesi, A, 2004
)
2.02
"Idarubicin is a substrate for CYP450 2D6 and 2C9. "( In vitro evaluation of cytochrome P450-mediated drug interactions between cytarabine, idarubicin, itraconazole and caspofungin.
Colburn, DE; Giles, FJ; Oladovich, D; Smith, JA, 2004
)
1.99
"Idarubicin is a 4-demethoxy-anthracycline analogue of daunorubicin that has proven activity in non-Hodgkin lymphoma, and has been reported to cause less cardiotoxicity."( Comparison of CHOP versus CIOP in good prognosis younger patients with histologically aggressive non-Hodgkin lymphoma.
Burton, C; Cunningham, D; Hancock, B; Hoskin, P; Linch, D; Qian, W; Smith, P; Vaughan-Hudson, G, 2005
)
1.05
"Idarubicin (IDR) is a new analog of Daunorubicin (DNR) selected for clinical trials because of its outstanding activity in experimental leukemias of mice and in several experimental models when compared to DNR and Doxorubicin. "( Phase I trial of Idarubicin (4-demethoxydaunorubicin) in adult acute leukemia.
Carde, P; Chahine, G; Hayat, M; Hurteloup, P; Kamioner, D; Parmentier, C; Pico, JO; Schlumberger, M, 1984
)
2.05
"Idarubicin is a new anthracycline, more potent in in vitro models than the common anthracyclines doxorubicin and daunorubicin. "( Comparative evaluation of the intracellular accumulation and DNA binding of idarubicin and daunorubicin in sensitive and multidrug-resistant human leukaemia K562 cells.
Bogush, T; Robert, J,
)
1.8
"Idarubicin (IDA) is a daunorubicin (DAU) analog that is being used to treat a variety of human malignancies. "( Cellular pharmacology of idarubicinol in multidrug-resistant LoVo cell lines.
Boiocchi, M; Corona, G; De Angeli, S; Gigante, M; Simone, F; Toffoli, G, 1996
)
2.04
"Idarubicin is a highly lipophilic anthracycline and appears effective against tumours resistant to conventional anthracyclines. "( Confocal microscopy of idarubicin localisation in sensitive and multidrug-resistant bladder cancer cell lines.
Cooper, A; Duffy, PM; Hayes, MC; Smart, CJ, 1996
)
2.05
"Idarubicin is an effective drug in acute leukemia but its use in non-Hodgkin lymphomas (NHLs) is not yet well established. "( Idarubicin in patients with diffuse large cell lymphomas: a randomized trial comparing VACOP-B (A = doxorubicin) vs VICOP-B (I = idarubicin).
Bertini, M; Botto, B; Calvi, R; Freilone, R; Gallamini, A; Gatti, AM; Liberati, AM; Meneghini, V; Orlandi, E; Orsucci, L; Pizzuti, M; Resegotti, L; Rota Scalabrini, D; Salvi, F; Todeschini, G; Vitolo, U,
)
3.02
"Idarubicin is an anthracycline agent available as both oral and intravenous formulations. "( Oral idarubicin. A review of its pharmacological properties and clinical efficacy in the treatment of haematological malignancies and advanced breast cancer.
Buckley, MM; Lamb, HM, 1997
)
2.25
"Idarubicin is a very effective drug for the early management of adult acute lymphoblastic leukaemia and may be presently considered (along with cyclosporin-A or other modulator) as the reference anthracycline for cases overexpressing the P-glycoprotein drug resistance mechanism."( The role of idarubicin in adult acute lymphoblastic leukaemia: from drug resistance studies to clinical application.
Barbui, T; Bassan, R; Borleri, G; Chiodini, B; Lerede, T; Rambaldi, A; Torri, V, 1997
)
1.4
"Idarubicin is an effective agent in the treatment of acute myeloid leukaemia (AML), inducing complete remission in 39 to 80% of newly diagnosed patients. "( Idarubicin: a pharmacoeconomic evaluation of its use in adult patients with acute myeloid leukaemia.
Goa, KL; Whittington, R, 1993
)
3.17
"Oral idarubicin (IDA) is an active drug in metastatic breast cancer, but its role in the management of this tumor is yet not established completely. "( Dose-finding and pharmacologic study of chronic oral idarubicin therapy in metastatic breast cancer patients.
Aita, P; Bearz, A; Boiocchi, M; Colussi, AM; Corona, G; Crivellari, D; Robieux, I; Sorio, R; Stocco, F; Toffoli, G, 2000
)
1.07
"Idarubicin (IDA) is an anthracycline used during treatment of acute myelogenous leukaemia (AML) and is clinically important because of its potency and lipophilicity (compared to the related compounds daunorubicin and doxorubicin). "( Formation and longevity of idarubicin-induced DNA topoisomerase II cleavable complexes in K562 human leukaemia cells.
Austin, CA; Errington, F; Tilby, MJ; Willmore, E, 2002
)
2.05
"Idarubicin is an anthracycline anticancer drug used in haematological malignancies. "( Genotoxicity of idarubicin and its modulation by vitamins C and E and amifostine.
Błasiak, J; Gloc, E; Majsterek, I; Młynarski, W; Skórski, T; Stolarska, M; Woźniak, K, 2002
)
2.1
"Idarubicin is an effective agent for the management of acute nonlymphocytic leukemia and is reportedly more potent and less cardiotoxic than daunorubicin or doxorubicin."( Idarubicin: an anthracycline antineoplastic agent.
Cersosimo, RJ, 1992
)
2.45
"Idarubicin in i.v. form is an active drug in previously treated patients with unfavorable non-Hodgkin's lymphoma."( Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.
Case, DC; Crawford, J; Gams, RA; Gerber, MC; Gould, J; Higano, CS; Pruitt, BT; Votaw, ML, 1992
)
1.29
"Idarubicin is a 4-demethoxy-anthracycline analogue of daunorubicin which, when administered intravenously in combination with cytarabine, has therapeutic efficacy superior to that of standard induction and salvage treatment regimens in acute myelogenous leukaemia. "( Idarubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in the chemotherapy of cancer.
Faulds, D; Hollingshead, LM, 1991
)
3.17
"Idarubicin is a new anthracycline derivative with therapeutic efficacy in metastatic breast cancer. "( Oral administration of idarubicin as first line cytostatic therapy in patients with metastasized breast cancer and favourable prognosis. A trial of the phase II study group of the Association for Medical Oncology of the German Cancer Society.
Bremer, K; Donhuijsen-Ant, R; Fritze, D; Klee, M; Possinger, K; Queisser, W; Rieche, K; Wagner, H; Westerhausen, M; Worst, P, 1991
)
2.03
"Idarubicin is a new derivative of Daunorubicin which was found to be more potent and more active than Daunorubicin and Doxorubicin in several experimental leukemias. "( Idarubicin in the treatment of acute leukemias. An overview of preclinical and clinical studies.
Berman, E; Carella, AM; Ganzina, F; Maraone, MP,
)
3.02
"Idarubicin in oral form is an active drug in previously treated patients with favorable histology non-Hodgkin's lymphoma."( Phase II study of oral idarubicin in favorable histology non-Hodgkin's lymphoma.
Case, DC; Dorsk, BM; Ervin, TJ; Gams, R; Gerber, M; Hayes, DM, 1990
)
1.31
"Idarubicin (IDR) is a new anthracycline that can be administered orally. "( Treatment of acute myeloid leukemia in elderly patients with oral idarubicin as a single agent.
Guy, H; Harousseau, JL; Hurteloup, P; Milpied, N; Pris, J; Rigal-Huguet, F, 1989
)
1.96
"Idarubicin (IDA) is an anthracycline analog which differs from the parent compound by the substitution of a C4 methoxyl group with an hydrogen atom in the aglycone moiety. "( A phase II study of idarubicin (4-demethoxydaunorubicin) in advanced myeloma.
Capnist, G; Chisesi, T; de Dominicis, E; Dini, E, 1988
)
2.04
"Idarubicin is a derivative of daunomycin and is characterized by the absence of the methoxyl group at the C-4 position. "( Immunochemotherapy of a murine thymoma with the use of idarubicin monoclonal antibody conjugates.
McKenzie, IF; Pietersz, GA; Smyth, MJ, 1988
)
1.96

Effects

Idarubicin has been used as the main drug in induction chemotherapy for acute myelogenous leukemia (AML) in the USA and Europe. It has a superior CR rate as well as long-term disease-free survival in comparison with daunorubsicin.

ExcerptReferenceRelevance
"Idarubicin has a superior CR rate as well as long-term disease-free survival in comparison with daunorubicin, and it is becoming the first line treatment for acute myelogenous leukemia in adults."( [Current situation and perspective for treatment of acute myelogenous leukemia in adults].
Fukushima, T; Ueda, T, 1998
)
1.02
"Idarubicin has been successfully encapsulated in cholesterol-free liposomes, however, little is known about how the rate of drug release from circulating liposomes influences therapeutic activity. "( Substantial increases in idarubicin plasma concentration by liposome encapsulation mediates improved antitumor activity.
Bally, MB; Dos Santos, N; Edwards, K; Karlsson, G; Masin, D; Tardi, PG; Waterhouse, D, 2005
)
2.07
"Idarubicin has a superior CR rate as well as long-term disease-free survival in comparison with daunorubicin, and it is becoming the first line treatment for acute myelogenous leukemia in adults."( [Current situation and perspective for treatment of acute myelogenous leukemia in adults].
Fukushima, T; Ueda, T, 1998
)
1.02
"Idarubicin has been shown to have similar or superior antileukemic activity to daunorubicin with less cumulative cardiotoxicity. "( Acute neurohumoral and cardiovascular effects of idarubicin in leukemia patients.
Hartikainen, J; Jantunen, E; Nousiainen, T; Puustinen, J; Rantala, A; Remes, J; Vanninen, E; Vuolteenaho, O, 1998
)
2
"Idarubicin has been added in 3 patients, with this addition occurring at 6 months in 2 patients and at 9 months in 1 patient."( Molecular remissions induced by liposomal-encapsulated all-trans retinoic acid in newly diagnosed acute promyelocytic leukemia.
Cortes, J; Estey, EH; Freireich, EJ; Giles, FJ; Kantarjian, H; Keating, M; Lopez-Berestein, G; O'Brien, S, 1999
)
1.02
"Idarubicin (IDR) has been used as the main drug in induction chemotherapy for acute myelogenous leukemia (AML) in the USA and Europe. "( [Outcome of acute myelogenous leukemia in 41 patients treated with idarubicin: the prognosis of t(8;21) cases].
Hatake, K; Komatsu, N; Matsumoto, Y; Mori, M; Muroi, K; Ohtsuki, T; Ozawa, K, 2001
)
1.99
"Idarubicinol has been reported to have greater cytotoxic activity than other anthracycline alcohol metabolites, which are regarded as much less active products of metabolism."( Anthracyclines and their C-13 alcohol metabolites: growth inhibition and DNA damage following incubation with human tumor cells in culture.
Ames, MM; Kuffel, MJ; Reid, JM, 1992
)
1
"Idarubicin has at least equivalent activity to daunorubicin and doxorubicin in leukemia."( New anthracycline antitumor antibiotics.
Green, MD; Muggia, FM, 1991
)
1
"Idarubicin also has the advantage of oral administration, but the oral formulation of the drug remains investigational."( Idarubicin: a second-generation anthracycline.
Fields, SM; Koeller, JM, 1991
)
2.45
"Idarubicin has prolonged retention in the plasma and has equal cytotoxic activity to the parent compound."( Phase I and II agents in cancer therapy: I. Anthracyclines and related compounds.
Fuks, JZ; Wadler, S; Wiernik, PH,
)
0.85
"Idarubicinol has been shown to be an active metabolite in experimental models, being as potent and as active as the parent compound."( Idarubicin (4-demethoxydaunorubicin). A preliminary overview of preclinical and clinical studies.
Di Pietro, N; Ganzina, F; Pacciarini, MA, 1986
)
2.44
"Idarubicin has already been shown to be an important antileukaemic agent in Phase II-III studies."( Clinical studies with new anthracyclines: epirubicin, idarubicin, esorubicin.
Ganzina, F; Hurteloup, P, 1986
)
1.24

Treatment

Idrubicin treatments altered the expression of 58 genes, and 16 of those were expressed at significantly different level. The idarubicIn treated subline, K/IDA, was only resistant to taxol but was 12-fold sensitized to etoposide.

ExcerptReferenceRelevance
"Idarubicin treatments altered the expression of 58 genes, and 16 of those were expressed at significantly different level."( Dexrazoxane Averts Idarubicin-Evoked Genomic Damage by Regulating Gene Expression Profiling Associated With the DNA Damage-Signaling Pathway in BALB/c Mice.
Ahmad, SF; Al-Hamamah, MA; Alshahrani, AY; Ansari, MA; Attia, MM; Attia, SM; Bakheet, SA; Nadeem, A; Saquib, Q, 2017
)
1.5
"Idarubicin-treated animals exhibited a decrease in body and heart weight, a decrease in myocardial contractility, and changes in ECG parameters (P<0.01)."( Protective role of antioxidant vitamin E and catechin on idarubicin-induced cardiotoxicity in rats.
Ates, A; Candan, S; Kalender, S; Kalender, Y; Olcay, E; Yel, M, 2002
)
1.28
"The idarubicin treated subline, K/IDA, was only resistant to taxol but was 12-fold sensitized to etoposide, suggesting that idarubicin had affected topoisomerase II in this subline."( Development of drug resistance is reduced with idarubicin relative to other anthracyclines.
Davey, MW; Davey, RA; Hargrave, RM; Kidman, AD, 1995
)
1.03

Toxicity

Idarubicin (IDR) is one of the most effective, but also toxic drugs in the treatment of AML. Vitamin E and catechin can reduce the toxic effects of IDR.

ExcerptReferenceRelevance
" Gastrointestinal morbidity was less in the cohort treated without Ara-C; however, infectious morbidity persisted at unacceptable levels and this program was terminated as too toxic to administer."( Severe toxicity limits intensification of induction therapy for acute lymphoblastic leukemia.
Berman, E; Gaynor, J; Gee, T; Kempin, S; Kritz, A; Little, C; Scheinberg, D; Sogoloff, H; Telford, P; Weiss, M, 1993
)
0.29
" We illustrate a new statistical design strategy for monitoring both adverse and efficacy outcomes on a patient-by-patient basis in phase II and other single-arm clinical trials."( New statistical strategy for monitoring safety and efficacy in single-arm clinical trials.
Estey, EH; Simon, RM; Thall, PF, 1996
)
0.29
" We conclude that a combination of idarubicin and etoposide given orally as first-line treatment in elderly patients with AML is safe and effective."( The use of an all oral chemotherapy (idarubicin and etoposide) in the treatment of acute myeloid leukaemia in the elderly: a report of toxicity and efficacy.
Galloway, MJ; Hamilton, PJ; Haynes, A; Iqbal, A; Jackson, GH; Proctor, SJ; Russell, N; Taylor, PR; Turner, G, 1997
)
0.85
" Furthermore, CsA-treated patients had greater, and more severe, oral and intestinal mucosal toxicity, with more severe adverse events, including more cases of gram-negative bacteremia, and with a delayed hemopoietic recovery."( Adjuvant treatment with cyclosporin A increases the toxicity of chemotherapy for remission induction in acute non-lymphocytic leukemia.
Baccarani, M; Baraldo, M; Damiani, D; Ermacora, A; Fanin, R; Furlanut, M; Michieli, M; Pea, F; Russo, D; Zaja, F, 1998
)
0.3
"Acute toxic effects of the antineoplastic anthraquinones carminomycin, epirubicin, idarubicin and mitoxantrone were studied in primary cultures of cardiomyocytes, which were isolated from adult rats."( Anthraquinone-induced cell injury: acute toxicity of carminomycin, epirubicin, idarubicin and mitoxantrone in isolated cardiomyocytes.
Andersson, BS; Carlberg, M; Eksborg, S; Sundberg, M; Vidal, RF, 1999
)
0.76
"Idarubicin (IDR) is one of the most effective, but also toxic drugs in the treatment of AML."( Toxicity and effectiveness of high-dose idarubicin during AML induction therapy: results of a pilot study in children.
Behnisch, W; Bender-Götze, C; Creutzig, U; Graf, N; Hermann, J; Kabisch, H; Körholz, D; Mann, G; Niemeyer, CM; Reiter, A; Ritter, J; Scheel-Walter, H; Zimmermann, M,
)
1.84
" In this study, we assessed the effect of a novel IH636 grape seed proanthocyanidin extract (GSPE) to ameliorate chemotherapy-induced toxic effects in cultured Chang epithelial cells, established from nonmalignant human tissue."( Amelioration of the cytotoxic effects of chemotherapeutic agents by grape seed proanthocyanidin extract.
Bagchi, D; Bagchi, M; Benner, EJ; Joshi, SS; Kuszynski, CA, 1999
)
0.3
" Therefore, synergistic cytotoxicity of Idarubicin for lymphoma cells treated with an oligonucleotide targeting p53 message was demonstrated at oligonucleotide and Idarubicin concentrations which were minimally toxic to hematopoietic progenitor cells."( Oligonucleotide enhanced cytotoxicity of Idarubicin for lymphoma cells.
Benner, EJ; Bishop, MR; Copple, B; Greiner, TC; Iversen, PL; Jackson, JD; Joshi, SS; Mann, SL; Rao, AK; Sharp, JG; Vose, JM, 2001
)
0.84
" The main side effect of idarubicin is free-radicals based cardiotoxicity."( Genotoxicity of idarubicin and its modulation by vitamins C and E and amifostine.
Błasiak, J; Gloc, E; Majsterek, I; Młynarski, W; Skórski, T; Stolarska, M; Woźniak, K, 2002
)
0.96
" In the present study we investigated whether vitamin E and catechin can reduce the toxic effects of idarubicin."( Protective role of antioxidant vitamin E and catechin on idarubicin-induced cardiotoxicity in rats.
Ates, A; Candan, S; Kalender, S; Kalender, Y; Olcay, E; Yel, M, 2002
)
0.78
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Safety was measured using the NCI classification system of common toxicity criteria for adverse events."( [Effectiveness and safety of the FLAG-IDA regimen in acute refractory or recurrent leukaemia].
Domínguez Senín, L; Garrido Martínez, MT; Martín Chacón, E; Rodríguez Rodríguez, JN; Sánchez Argáiz, M,
)
0.13
" Severe TACE-related toxicity was defined as the occurrence of any adverse event grade ≥ 4, or any adverse event that caused a prolongation of hospitalisation of >8 days, or any additional hospitalisation within 1 month after TACE."( Predictive factors of transarterial chemoembolisation toxicity in unresectable hepatocellular carcinoma.
Adam, H; Aho, LS; Bedenne, L; Boulin, M; Cercueil, JP; Di Martino, C; Fagnoni, P; Guiu, B; Hillon, P; Jouve, JL; Lepage, C; Minello, A, 2014
)
0.4
" There was a statistically significantly lower rate of grades 3 and 4 gastrointestinal adverse events in the palifermin arm (21% vs."( A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia.
Bradstock, KF; Collins, M; Cull, G; Di Iulio, J; Enno, A; Hahn, U; Lewis, ID; Link, E; Marlton, P; Schwarer, A; Seymour, JF; Szer, J, 2014
)
0.4
" The efficacy, adverse effects and long- term prognosis among the three groups were compared."( [Efficacy and safety analysis of different dose idarubicin plus cytarabine regimen as induction chemotherapy for young patients with de-novo acute myeloid leukemia].
Jin, J; Mai, WY; Mao, LP; Meng, HT; Qian, WB; Suo, SS; Tong, HY; Wei, JY; Yao, XM; Yu, WJ; Zhang, Y; Zhu, SL, 2016
)
0.69
" The adverse effects were similar in the three group, other than the lowest count of WBC (P=0."( [Efficacy and safety analysis of different dose idarubicin plus cytarabine regimen as induction chemotherapy for young patients with de-novo acute myeloid leukemia].
Jin, J; Mai, WY; Mao, LP; Meng, HT; Qian, WB; Suo, SS; Tong, HY; Wei, JY; Yao, XM; Yu, WJ; Zhang, Y; Zhu, SL, 2016
)
0.69
" The adverse effects were similar in the three groups."( [Efficacy and safety analysis of different dose idarubicin plus cytarabine regimen as induction chemotherapy for young patients with de-novo acute myeloid leukemia].
Jin, J; Mai, WY; Mao, LP; Meng, HT; Qian, WB; Suo, SS; Tong, HY; Wei, JY; Yao, XM; Yu, WJ; Zhang, Y; Zhu, SL, 2016
)
0.69
" An important side effect of linezolid is linezolid-induced thrombocytopenia; so, the safety of linezolid for AML patients in myelosuppression is of concern."( Linezolid is safe on platelet count for AML patients during myelosuppression after consolidation chemotherapy.
Shi, T; Xie, W; Yang, X; Ye, X; Zhao, S; Zhu, J; Zhu, L, 2020
)
0.56
"This retrospective clinical study suggests that it is safe to manage AML patients in complete remission during myelosuppression after standard consolidation chemotherapy with idarubicin and cytarabine, with about 7 days of linezolid therapy."( Linezolid is safe on platelet count for AML patients during myelosuppression after consolidation chemotherapy.
Shi, T; Xie, W; Yang, X; Ye, X; Zhao, S; Zhu, J; Zhu, L, 2020
)
0.75
" The secondary outcomes included adverse events and cytogenetic risk in subgroup analyses."( The efficacy and safety of daunorubicin versus idarubicin combined with cytarabine for induction therapy in acute myeloid leukemia: A meta-analysis of randomized clinical trials.
Lu, Y; Wang, H; Wu, Y; Xiao, Q; Xiao, X, 2020
)
0.82
" When it comes to adverse drug reactions, it is not a significant difference."( The efficacy and safety of daunorubicin versus idarubicin combined with cytarabine for induction therapy in acute myeloid leukemia: A meta-analysis of randomized clinical trials.
Lu, Y; Wang, H; Wu, Y; Xiao, Q; Xiao, X, 2020
)
0.82
"L-DNR proved to be an effective drug within a multiagent approach, which shows a favorable overall profile, as well as similar adverse events when compared with IDA in HR-ALL."( Efficacy and safety of induction chemotherapy with daunorubicin or idarubicin in the treatment of an adult with acute lymphoblastic leukemia.
Wang, D; Wang, ZD; Zhang, CH; Zhang, Q, 2022
)
0.96
"Cardiotoxicity is the major side effect of anthracyclines (doxorubicin, daunorubicin, epirubicin, and idarubicin), though being the most commonly used chemotherapy drugs and the mainstay of therapy in solid and hematological neoplasms."( The Role of Mitochondrial Quality Control in Anthracycline-Induced Cardiotoxicity: From Bench to Bedside.
Bai, R; Chang, X; Li, L; Li, Y; Lin, R; Liu, N; Liu, X; Peng, X; Ruan, Y; Tang, R; Wang, X; Wen, S, 2022
)
0.94

Pharmacokinetics

An open phase II pharmacokinetic and clinical study was performed to evaluate antileukemic efficacy, IDA pharmacokinetics and to investigate the presence of IDA and its reduced metabolite idarubicinol in cerebrospinal fluid.

ExcerptReferenceRelevance
" The AUCs obtained for unchanged drugs were proportional to the dose, and the dose-independent pharmacokinetic parameters were very similar for the two drugs: total plasma clearance (39."( Comparative pharmacokinetic study of idarubicin and daunorubicin in leukemia patients.
Hurteloup, P; Rigal-Huguet, F; Robert, J,
)
0.4
" The IDAol terminal half-life and mean residence time (MRT) were significantly increased in patients with impaired kidney function [MRT: group N, 63."( Idarubicin metabolism and pharmacokinetics after intravenous and oral administration in cancer patients: a crossover study.
Camaggi, CM; Carisi, P; Efthymiopoulos, C; Guaraldi, M; Martoni, A; Pannuti, F; Strocchi, E; Strolin-Benedetti, M; Tononi, A, 1992
)
1.73
" Due to its protracted half-life (64 hr in this study), this metabolite progressively accumulated and the ratio of the areas under the curve (0-24) idarubicinol/idarubicin increased from day to day."( Pharmacokinetics of idarubicin after oral administration in elderly leukemic patients.
Huet, S; Hurteloup, P; Pris, J; Rigal-Huguet, F; Robert, J, 1990
)
0.8
" There was substantial variability in idarubicin elimination among patients, but no indication of dose-dependent or of schedule-dependent changes in pharmacokinetic parameters."( Plasma pharmacokinetics and cerebrospinal fluid concentrations of idarubicin and idarubicinol in pediatric leukemia patients: a Childrens Cancer Study Group report.
Ames, MM; Hammond, GD; Krailo, MD; Pendergrass, TW; Reid, JM, 1990
)
0.79
" No pharmacokinetic modelling of Idarubicin was possible after oral administration."( Plasma pharmacokinetics of Idarubicin and its 13-hydroxymetabolite after intravenous and oral administration under fasting and non-fasting conditions.
Antila, K; Eksborg, S; Nilsson, B; Söderberg, M, 1990
)
0.86
" No correlation was found between the pharmacokinetic parameters and the time to final progression."( Pharmacokinetics of oral idarubicin in breast cancer patients with reference to antitumor activity and side effects.
Bastholt, L; Dalmark, M; Ebbehøj, E; Elbaek, K; Jakobsen, A; Juul, P; Rasmussen, SN; Steiness, E, 1989
)
0.58
" Each molecule is characterized by original metabolic and pharmacokinetic features, which can be compared to those of the reference anthracyclines, doxorubicin and daunorubicin."( [Pharmacokinetics of new anthracyclines].
Robert, J, 1988
)
0.27
" Pharmacokinetic parameters calculated for the intravenous plasma drug concentration, time data revealed a terminal half-life of 12."( Pharmacokinetics of idarubicin (4-demethoxydaunorubicin; IMI-30; NSC 256439) following intravenous and oral administration in patients with advanced cancer.
Gillies, HC; Harper, PG; Herriott, D; Liang, R; Ohashi, K; Rogers, HJ, 1987
)
0.6
" For unchanged idarubicin, similar pharmacokinetic parameters were exhibited after the 1st and the 5th injection."( Pharmacokinetics of idarubicin after daily intravenous administration in leukemic patients.
Harousseau, JL; Huet, S; Hurteloup, P; Pris, J; Reiffers, J; Rigal-Huguet, F; Robert, J; Tamassia, V, 1987
)
0.95
" The apparent terminal half-life of IDAol was significantly longer in the elderly than in the younger patients (mean half-life 59."( Attenuated-dose idarubicin in acute myeloid leukaemia of the elderly: pharmacokinetic study and clinical results.
Caporale, R; Cervi, L; Ciolli, S; Giuliani, G; Leoni, F; Pascarella, A; Rossi Ferrini, P; Salti, F, 1995
)
0.64
" Although idarubicin was given in one-fifth of the dose, the intracellular peak concentration was 70% of that of daunorubicin."( Comparison of the intracellular pharmacokinetics of daunorubicin and idarubicin in patients with acute leukemia.
Paul, C; Sundman-Engberg, B; Tidefelt, U, 1994
)
0.93
" The average terminal half-life was 30."( Oral idarubicin pharmacokinetics--correlation of trough level with idarubicin area under curve.
Braess, J; Hiddemann, W; Kaufmann, CC; Kern, W; Kühn, S; Rührs, H; Schleyer, E; Sträubel, G; Unterhalt, M, 1996
)
0.81
" The plasma concentration time course of Ida was most properly described by the three-compartment pharmacokinetic model, independent of administration time."( Plasma pharmacokinetics of idarubicin and its 13-dihydro metabolite--a comparison of bolus versus 2 h infusion during a 3 day course.
Björkholm, M; Eksborg, S; Fagerlund, E; Hast, R, 1997
)
0.59
" The average terminal half-life was 30."( Oral idarubicin pharmacokinetics--correlation of trough level with idarubicin area under curve.
Braess, J; Hiddemann, W; Kaufmann, CC; Kern, W; Kühn, S; Rührs, H; Schleyer, E; Sträubel, G; Unterhalt, M, 1997
)
0.81
" With respect to cellular resistance mechanisms, 2 different pharmacodynamic phases can be distinguished: intracellular distribution and cellular reaction."( Intracellular pharmacokinetics of anthracyclines in human leukemia cells: correlation of DNA-binding with apoptotic cell death.
Brieden, T; Gieseler, F; Kunze, J; Nüssler, V; Valsamas, S, 1998
)
0.3
" Pharmacokinetic evaluations were performed by means of a two-compartment open model with zero-order absorption and first-order elimination using the WinNonlin pharmacokinetic software package."( Multidrug resistance modulation in vivo: the effect of cyclosporin A alone or with dexverapamil on idarubicin pharmacokinetics in acute leukemia.
Baccarani, M; Baraldo, M; Damiani, D; Ermacora, A; Fanin, R; Furlanut, M; Michieli, M; Pea, F; Russo, D, 1999
)
0.52
" The main pharmacokinetic parameters of IDA, such as CL and volume of distribution at steady state (Vdss), were remarkably affected by the coadministration of CyA or CyA plus D-Ver, but no statistically significant difference was noted because of IDA pharmacokinetic interpatient variation."( Multidrug resistance modulation in vivo: the effect of cyclosporin A alone or with dexverapamil on idarubicin pharmacokinetics in acute leukemia.
Baccarani, M; Baraldo, M; Damiani, D; Ermacora, A; Fanin, R; Furlanut, M; Michieli, M; Pea, F; Russo, D, 1999
)
0.52
"The results show that CyA alone at a dose of 10 mg x kg(-1) daily significantly increased systemic body exposure to both IDA and IDAOL in acute leukemia, and suggest that these pharmacokinetic effects were at least partially decreased when D-Ver was coadministered with CyA."( Multidrug resistance modulation in vivo: the effect of cyclosporin A alone or with dexverapamil on idarubicin pharmacokinetics in acute leukemia.
Baccarani, M; Baraldo, M; Damiani, D; Ermacora, A; Fanin, R; Furlanut, M; Michieli, M; Pea, F; Russo, D, 1999
)
0.52
" Various pharmacokinetic profiles, with and without clinically relevant peak concentrations, were simulated in vitro."( Induction of apoptosis by idarubicin: how important is the plasma peak?
Clark, M; Gieseler, F; Puschmann, M; Stiebeling, K; Valsamas, S, 2000
)
0.61
" We simulated a bolus application and a continuous infusion using two different pharmacokinetic profiles of idarubicin with comparable AUCs (area under the time curve)."( Induction of apoptosis by idarubicin: how important is the plasma peak?
Clark, M; Gieseler, F; Puschmann, M; Stiebeling, K; Valsamas, S, 2000
)
0.82
"To clarify the pharmacokinetic properties of idarubicin (IDA) in Japanese patients and to clarify the relationship between the pharmacokinetic parameters of IDA or idarubicinol (IDAol), an active metabolite of IDA, and leukocytopenia or neutropenia, we examined the pharmacokinetics of IDA in patients with malignant lymphoma."( A pharmacokinetic study of idarubicin in Japanese patients with malignant lymphoma: relationship with leukocytopenia and neutropenia.
Fukushima, T; Goto, N; Kuraishi, Y; Ogawa, M; Ohno, R; Okabe, KI; Ueda, T; Urabe, A; Yamashita, T, 2001
)
0.87
" The plasma concentration-time data were analysed, assuming a biexponential disposition curve, both by the traditional (two-stage) method and by population pharmacokinetic modelling."( Pharmacokinetics and toxicity of idarubicin in the rat.
Hofmann, S; Kuhlmann, O; Weiss, M,
)
0.41
" The pharmacokinetic parameters of idarubicin found after duodenal administration of the two formulations were different: area under the curve of concentration versus time (AUC) and elimination half-life were approximately 21 times and 30 times, respectively, higher after IDA-SLN administration than after the solution administration."( Pharmacokinetics and tissue distribution of idarubicin-loaded solid lipid nanoparticles after duodenal administration to rats.
Bargoni, A; Cavalli, R; Fundarò, A; Gasco, MR; Vighetto, D; Zara, GP, 2002
)
0.85
" Using a pharmacodynamic (PD) approach, the authors examined the validity of this model for patients with acute myeloid leukemia (AML) undergoing dose-intensive postinduction chemotherapy (HDT)."( Pharmacodynamic modeling of thrombopoietin, platelet, and megakaryocyte dynamics in patients with acute myeloid leukemia undergoing dose intensive chemotherapy.
Bernstein, SH; Jusko, WJ; Krzyzanski, W; Nichol, J; Wetzler, M, 2002
)
0.31
"The peak plasma levels (C(max)), terminal elimination half-life (t(1/2)) and area under the concentration curve (AUC) both for IDA and for ETO did not differ from published data."( Increased myelotoxicity of idarubicin: is there a pharmacological basis? Results of a pharmacokinetic and an in vitro cytotoxicity study.
Bornhäuser, M; Ehninger, G; Illmer, T; Kroschinsky, F; Renner, U; Schaich, M; Schimmelpfennig, C; Schimming, C; Schleyer, E; Trümper, L, 2004
)
0.62
" An open phase II pharmacokinetic and clinical study was performed to evaluate antileukemic efficacy, IDA pharmacokinetics and to investigate the presence of IDA and its reduced metabolite idarubicinol (IDAol) in cerebrospinal fluid (CSF) of patients treated with HD-IDA."( High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study.
Baratè, C; Cafro, AM; Camaggi, CM; Intropido, L; Marbello, L; Montillo, M; Morra, E; Nichelatti, M; Strocchi, E; Tedeschi, A; Tresoldi, E, 2007
)
0.93
" The mean terminal half-life measured for IDA in this group of patients (14."( High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study.
Baratè, C; Cafro, AM; Camaggi, CM; Intropido, L; Marbello, L; Montillo, M; Morra, E; Nichelatti, M; Strocchi, E; Tedeschi, A; Tresoldi, E, 2007
)
0.74
" Our data do not allow us to clearly attribute this behavior to a pharmacokinetic non-linearity since the baseline creatinine clearance, even within normal values, and patient age are significantly different in the two groups."( High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study.
Baratè, C; Cafro, AM; Camaggi, CM; Intropido, L; Marbello, L; Montillo, M; Morra, E; Nichelatti, M; Strocchi, E; Tedeschi, A; Tresoldi, E, 2007
)
0.74
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"To investigate the relationship between the improved stability of an anticancer drug-lipiodol emulsion and pharmacokinetic (PK) profile for transarterial chemoembolisation (TACE) of hepatocellular carcinoma (HCC)."( Improved stability of lipiodol-drug emulsion for transarterial chemoembolisation of hepatocellular carcinoma results in improved pharmacokinetic profile: Proof of concept using idarubicin.
Boulin, M; Cercueil, JP; Delhom, E; Denys, A; Fohlen, A; Guiu, B; Herrero, A; Imbs, DC; Panaro, F; Schmitt, A; Wendremaire, M, 2016
)
0.63
" After TACE, mean idarubicin Cmax and AUC0-24h were 12."( Improved stability of lipiodol-drug emulsion for transarterial chemoembolisation of hepatocellular carcinoma results in improved pharmacokinetic profile: Proof of concept using idarubicin.
Boulin, M; Cercueil, JP; Delhom, E; Denys, A; Fohlen, A; Guiu, B; Herrero, A; Imbs, DC; Panaro, F; Schmitt, A; Wendremaire, M, 2016
)
0.96
" • Improved emulsion stability for TACE resulted in a favourable pharmacokinetic profile."( Improved stability of lipiodol-drug emulsion for transarterial chemoembolisation of hepatocellular carcinoma results in improved pharmacokinetic profile: Proof of concept using idarubicin.
Boulin, M; Cercueil, JP; Delhom, E; Denys, A; Fohlen, A; Guiu, B; Herrero, A; Imbs, DC; Panaro, F; Schmitt, A; Wendremaire, M, 2016
)
0.63

Compound-Compound Interactions

A randomized clinical trial was undertaken to compare the therapeutic effectiveness of idarubicin (IDR) to daunorubic in acute myelogenous leukemic (AML) patients. Eighteen adult patients with relapsed/refractory ALL were treated on a phase I study of high-dose cytarabine combined with a single escalating dose of idarsicin.

ExcerptReferenceRelevance
"A randomized clinical trial was undertaken to compare the therapeutic effectiveness of idarubicin (IDR) to daunorubicin (DNR), and both were given in combination with cytarabine (CA) in acute myelogenous leukemic (AML) patients."( A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group Study.
Banks, PL; Bartolucci, AA; Flaum, MA; Gerber, MC; Omura, GA; Velez-Garcia, E; Vogler, WR; Weiner, RS, 1992
)
0.8
"We conducted a Phase I-II trial of 4-demethoxydaunorubicin (idarubicin, IDR) in combination with 1-beta-D-arabinofuranosylcytosine (ara-C) in 51 patients with relapsed or refractory acute nonlymphocytic leukemia, acute lymphocytic leukemia, or chronic myelogenous leukemia in blast crisis."( 4-demethoxydaunorubicin (idarubicin) in combination with 1-beta-D-arabinofuranosylcytosine in the treatment of relapsed or refractory acute leukemia.
Arlin, ZA; Berman, E; Clarkson, BD; Daghestani, A; Gee, TS; Hancock, C; Kempin, S; Raymond, V; Stevens, YW; Williams, L, 1989
)
0.82
" When combined with Cytarabine, Idarubicin increased the incidence and severity of gastrointestinal symptoms."( [Early phase II study of Idarubicin combined with cytarabine in acute myelogenous leukemia. Idarubicin Study Group].
Kimura, K; Masaoka, T; Ogawa, M; Yamada, K, 1993
)
0.87
"The antitumor effects of Behenoyl-ara-C (BH-AC) in combination with Idarubicin (IDA) on leukemia were studied."( [Antitumor effects of Behenoyl-ara-C (BH-AC) in combination with Idarubicin (IDA) in P 388 leukemic cell bearing mice].
Kiyota, T; Kuriyama, H; Watanabe, A, 1996
)
0.77
" In this work we compared in vitro the effects of IDA and 2HIDA used alone and in combination with 2 microM cyclosporin A (CyA) in the MDR leukemic cell lines FLCR and K562R and in their sensitive parent cell lines FLC and K562."( Comparative activity of idarubicin and idarubicinol in combination with cyclosporin A in multidrug-resistant leukemia cells.
Abbadessa, V; Cajozzo, A; Gancitano, RA; Musso, M; Perricone, R; Porretto, F; Tolomeo, M, 1996
)
0.6
" We conclude that idarubicin in combination with cytarabine and etoposide is a highly effective regimen for induction in children with AML."( Results of treatment with an intensive induction regimen using idarubicin in combination with cytarabine and etoposide in children with acute myeloblastic leukemia.
Chantada, G; Cygler, AM; Felice, MS; Gallego, M; Rossi, J; Sackmann-Muriel, F; Zubizarreta, P,
)
0.7
"5-Aza-2'-deoxycytidine combined with either amsacrine or idarubicin has been applied in a treatment protocol for patients with a relapse of acute myeloid or lymphocytic leukemia."( A randomized phase II study on the effects of 5-Aza-2'-deoxycytidine combined with either amsacrine or idarubicin in patients with relapsed acute leukemia: an EORTC Leukemia Cooperative Group phase II study (06893).
Archimbaud, E; Berneman, Z; Dardenne, M; Dohner, H; Jaksic, B; Jehn, U; Labar, B; Louwagie, EA; Muus, P; Stryckmans, P; Suciu, S; Tjean, M; Wijermans, P; Willemze, R; Zittoun, R, 1997
)
0.76
"The Children's Cancer Group (CCG) undertook a phase I study (CCG-0922) to determine a tolerable dose of idarubicin given with fludarabine and cytarabine in children with relapsed or refractory leukemia."( Phase I/II study of idarubicin given with continuous infusion fludarabine followed by continuous infusion cytarabine in children with acute leukemia: a report from the Children's Cancer Group.
Avramis, VI; Dinndorf, PA; Kelleher, JF; Krailo, MD; Liu-Mares, W; Mosher, RB; Reaman, GH; Sato, JK; Seibel, NL; Wiersma, S, 1997
)
0.83
"A dose of idarubicin 12 mg/m2/d for 3 days given in combination with fludarabine and cytarabine was tolerated."( Phase I/II study of idarubicin given with continuous infusion fludarabine followed by continuous infusion cytarabine in children with acute leukemia: a report from the Children's Cancer Group.
Avramis, VI; Dinndorf, PA; Kelleher, JF; Krailo, MD; Liu-Mares, W; Mosher, RB; Reaman, GH; Sato, JK; Seibel, NL; Wiersma, S, 1997
)
1.02
"The anthracycline analogue idarubicin, either alone or in combination with other antineoplastic drugs, has shown antileukemic activity in relapsed and refractory acute lymphoblastic leukemia (ALL)."( A single high dose of idarubicin combined with high-dose ABA-C (MSKCC ALL-3 protocol) in adult and pediatric patients with acute lymphoblastic leukemia. Experience at the University La Sapienza of Rome.
Annino, L; Arcese, W; Chiaretti, S; D'Elia, G; Del Giudice, I; Ferrari, A; Giona, F; Mandelli, F; Moleti, ML; Testi, AM; Todisco, E,
)
0.74
"The anthracycline analogue idarubicin, either alone or in combination with other antineoplastic drugs, has shown antileukemic activity in relapsed and refractory acute lymphoblastic leukemia (ALL)."( A single high dose of idarubicin combined with high-dose ARA-C (MSKCC ALL-3 protocol) in adult and pediatric patients with acute lymphoblastic leukemia. Experience at the University "La Sapienza" of Rome.
Annino, L; Arcese, W; Chiaretti, S; D'Elia, G; Del Giudice, I; Ferrari, A; Giona, F; Mandelli, F; Moleti, ML; Testi, AM; Todisco, E,
)
0.74
" Eighteen adult patients with relapsed/refractory ALL were treated on a phase I study of high-dose cytarabine combined with a single escalating dose of idarubicin."( A phase I trial of a single high dose of idarubicin combined with high-dose cytarabine as induction therapy in relapsed or refractory adult patients with acute lymphoblastic leukemia.
Drullinsky, P; Golde, DW; Maslak, P; Scheinberg, D; Weiss, MA, 1998
)
0.76
"To determine the safety and efficacy of the combination of idarubicin, cytarabine and etoposide ("ICE") for induction and consolidation treatment of acute myeloid leukemia (AML), and of dose-intensification of cytarabine in this setting, 54 previously untreated patients in three cohorts were studied by sequential dose escalation of cytarabine, in combination with standard doses of idarubicin and etoposide."( A phase I/II study of intensive dose escalation of cytarabine in combination with idarubicin and etoposide in induction and consolidation treatment of adult acute myeloid leukemia. Australian Leukaemia Study Group (ALSG).
Bishop, JF; Bradstock, KF; Cobcroft, R; Eliadis, P; Enno, A; Gill, D; Herrmann, RP; Juneja, S; Lowenthal, RM; Manoharan, A; Matthews, JP; Page, FJ; Rooney, KF; Rosenfeld, D; Seldon, M; Taylor, KM; Wolf, MM; Young, GA, 1999
)
0.77
"We conclude that ATRA in combination with Ida and Ara-C can be administered safely to high-risk AML patients."( All trans retinoic acid in combination with intermediate-dose cytarabine and idarubicin in patients with relapsed or refractory non promyelocytic acute myeloid leukemia: a phase II randomized trial.
Anglaret, B; Archimbaud, E; Belhabri, A; Chelghoum, Y; Dhedin, N; Dombret, H; Fière, D; Michallet, M; Reman, O; Thomas, X; Vekhoff, A; Wattel, E, 2002
)
0.54
" 2-CdA in combination with DOX significantly increased the percentage of annexin V-positive cells, particularly after 48 h of incubation, as compared with DOX used in monotherapy (median AI for 2-CdA+DOX=37."( Evaluation of apoptosis induced in vitro by cladribine (2-CdA) combined with anthracyclines in lymphocytes from patients with B-cell chronic lymphocytic leukemia.
Najder, M; Robak, T; Smolewski, P; Szmigielska-Kaplon, A, 2002
)
0.31
" This study was conducted to define the dose-limiting toxicities (DLTs) of its combination with cytarabine (ara-C), idarubicin, or topotecan."( Randomized phase I/II study of troxacitabine combined with cytarabine, idarubicin, or topotecan in patients with refractory myeloid leukemias.
Cortes, JE; Douer, D; Estey, EH; Faderl, S; Garcia-Manero, G; Giles, FJ; Jeha, SS; Kantarjian, HM; Koller, CA; Levine, AM; O'Brien, SM; Thomas, DA, 2003
)
0.76
" The anthracyclines doxorubicin, daunorubicin, and idarubicin were individually combined with DEX to study in vitro effects in leukemic myeloid cell lines."( Dexrazoxane in combination with anthracyclines lead to a synergistic cytotoxic response in acute myelogenous leukemia cell lines.
Freireich, EJ; Jendiroba, D; Keyhani, A; Liu, B; Pagliaro, L; Pearlman, M, 2003
)
0.57
" Cytarabine metabolism was significantly decreased when combined with caspofungin or itraconazole."( In vitro evaluation of cytochrome P450-mediated drug interactions between cytarabine, idarubicin, itraconazole and caspofungin.
Colburn, DE; Giles, FJ; Oladovich, D; Smith, JA, 2004
)
0.55
"High dose (HD) Ara-C combined with a single HD idarubicin dose (IDA) is an efficient and safe salvage regimen for patients with refractory or relapsed acute lymphoblastic leukemia as indicated by phase II studies."( High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study.
Baratè, C; Cafro, AM; Camaggi, CM; Intropido, L; Marbello, L; Montillo, M; Morra, E; Nichelatti, M; Strocchi, E; Tedeschi, A; Tresoldi, E, 2007
)
1
" administration of 40 mg/m2 of IDA, combined with HD Ara-C, with a degree of myelosuppression equivalent to that reported with this agent administered in standard doses."( High-dose idarubicin in combination with Ara-C in patients with relapsed or refractory acute lymphoblastic leukemia: a pharmacokinetic and clinical study.
Baratè, C; Cafro, AM; Camaggi, CM; Intropido, L; Marbello, L; Montillo, M; Morra, E; Nichelatti, M; Strocchi, E; Tedeschi, A; Tresoldi, E, 2007
)
0.74
"The objective of this study was to investigate the efficacy and toxicity of standard-dose idarubicin in combination with continuous infusion of cytarabine as induction therapy in patients with acute myeloid leukemia (AML)."( [Standard-dose of idarubicin in combination with continuous infusion of cytarabine as induction therapy in patients with acute myeloid leukaemia].
Chen, LJ; Li, JY; Lu, H; Lu, RN; Qian, SX; Qiu, HX; Sheng, RL; Wu, HX; Xu, W, 2009
)
0.91
" We report on a phase I/II trial of the XIAP antisense oligonucleotide AEG35156 in combination with reinduction chemotherapy."( Phase I/II trial of AEG35156 X-linked inhibitor of apoptosis protein antisense oligonucleotide combined with idarubicin and cytarabine in patients with relapsed or primary refractory acute myeloid leukemia.
Altman, JK; Andreeff, M; Borthakur, G; Brandwein, J; Carter, BZ; Estey, EH; Hedley, DW; Jacob, C; Jolivet, J; Karp, JE; Kassis, J; LaCasse, E; Mak, DH; Morris, SJ; Schiller, GJ; Schimmer, AD; Tallman, MS; Xu, W, 2009
)
0.57
"Twenty-four patients with rapidly relapsed or refractory AML were treated with escalating doses of AEG35156 (12 to 250 mg/m(2)) as an intravenous solution over 2 hours and 32 patients were treated with the highest planned dose of 350 mg/m(2) in combination with idarubicin and high-dose cytarabine reinduction chemotherapy."( Phase I/II trial of AEG35156 X-linked inhibitor of apoptosis protein antisense oligonucleotide combined with idarubicin and cytarabine in patients with relapsed or primary refractory acute myeloid leukemia.
Altman, JK; Andreeff, M; Borthakur, G; Brandwein, J; Carter, BZ; Estey, EH; Hedley, DW; Jacob, C; Jolivet, J; Karp, JE; Kassis, J; LaCasse, E; Mak, DH; Morris, SJ; Schiller, GJ; Schimmer, AD; Tallman, MS; Xu, W, 2009
)
0.74
" Among the patients receiving 350 mg/m(2) of AEG35156 in combination with chemotherapy, 10 (91%) of 11 who were refractory to a single induction chemotherapy regimen achieved CR/CRp after reinduction with AEG35156 and chemotherapy."( Phase I/II trial of AEG35156 X-linked inhibitor of apoptosis protein antisense oligonucleotide combined with idarubicin and cytarabine in patients with relapsed or primary refractory acute myeloid leukemia.
Altman, JK; Andreeff, M; Borthakur, G; Brandwein, J; Carter, BZ; Estey, EH; Hedley, DW; Jacob, C; Jolivet, J; Karp, JE; Kassis, J; LaCasse, E; Mak, DH; Morris, SJ; Schiller, GJ; Schimmer, AD; Tallman, MS; Xu, W, 2009
)
0.57
"At the highest dose tested, AEG35156 knocks down its target and appears very effective when combined with chemotherapy in patients with AML refractory to a single induction regimen."( Phase I/II trial of AEG35156 X-linked inhibitor of apoptosis protein antisense oligonucleotide combined with idarubicin and cytarabine in patients with relapsed or primary refractory acute myeloid leukemia.
Altman, JK; Andreeff, M; Borthakur, G; Brandwein, J; Carter, BZ; Estey, EH; Hedley, DW; Jacob, C; Jolivet, J; Karp, JE; Kassis, J; LaCasse, E; Mak, DH; Morris, SJ; Schiller, GJ; Schimmer, AD; Tallman, MS; Xu, W, 2009
)
0.57
" The aim of this study was to investigate the cytotoxic effects of this agent in combination with conventional antileukemic agents."( The cytotoxic effects of gemtuzumab ozogamicin (mylotarg) in combination with conventional antileukemic agents by isobologram analysis in vitro.
Akutsu, M; Furukawa, Y; Izumi, T; Kano, Y; Mano, H; Miyawaki, S; Tanaka, M; Tsunoda, S; Yazawa, Y, 2009
)
0.35
"The cytotoxic effects of GO in combination with antileukemic agents were studied against human CD33 antigen-positive leukemia HL-60, U937, TCC-S and NALM20 cells."( The cytotoxic effects of gemtuzumab ozogamicin (mylotarg) in combination with conventional antileukemic agents by isobologram analysis in vitro.
Akutsu, M; Furukawa, Y; Izumi, T; Kano, Y; Mano, H; Miyawaki, S; Tanaka, M; Tsunoda, S; Yazawa, Y, 2009
)
0.35
" HDACi have single-agent clinical activity in haematological malignancies and have synergistic anti-leukaemia activity when combined with anthracyclines in vitro."( A phase I study of vorinostat in combination with idarubicin in relapsed or refractory leukaemia.
Egorin, MJ; Espinoza-Delgado, I; Ferrajoli, A; Garcia-Manero, G; Holleran, JL; Kadia, TM; Kantarjian, HM; Madden, TL; Maddipotti, S; Newsome, W; Ravandi, F; Sanchez-Gonzalez, B; Schroeder, C; Thomas, DA; Yang, H; Zwiebel, JA, 2010
)
0.61
"The authors conducted a phase 1/2 study of tipifarnib in combination with idarubicin and cytarabine (IA) in 95 patients with previously untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome."( A phase 1-2 study of a farnesyltransferase inhibitor, tipifarnib, combined with idarubicin and cytarabine for patients with newly diagnosed acute myeloid leukemia and high-risk myelodysplastic syndrome.
Cortes, J; Estrov, Z; Faderl, S; Garcia-Manero, G; Jabbour, E; Kantarjian, H; O'Brien, S; Ravandi, F; Thomas, DA; Verstovsek, S; Wright, JJ, 2011
)
0.83
"Although induction chemotherapy comprising high-dose cytarabine (HiDAC) in combination with idarubicin and etoposide or 'ICE' for adult acute myeloid leukaemia (AML) produces a complete remission rate of nearly 80%, gastrointestinal toxicity is significant."( High-dose cytarabine (24 g/m2) in combination with idarubicin (HiDAC-3) results in high first-cycle response with limited gastrointestinal toxicity in adult acute myeloid leukaemia.
Avery, S; Coutsouvelis, J; Lee, D; Low, M; Opat, S; Patil, S; Salem, H; Schwarer, A; Spencer, A; Walker, P; Wei, A, 2013
)
0.86
" We retrospectively evaluated the efficacy and toxicity of fractionated doses of gemtuzumab ozogamicin (GO) combined with a standard 3 + 7 induction regimen in young patients with AML in first relapse."( Fractionated doses of gemtuzumab ozogamicin combined with 3 + 7 induction chemotherapy as salvage treatment for young patients with acute myeloid leukemia in first relapse.
de Revel, T; Eddou, H; Foissaud, V; Konopacki, J; Malfuson, JV; Thepenier, C, 2012
)
0.38
" LY2181308 was administered with a loading dosage of three consecutive daily infusions of 750 mg followed by weekly intravenous (IV) maintenance doses of 750 mg."( Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML).
Andre, V; Andreeff, M; Brandt, JT; Callies, S; Erba, HP; Juckett, M; Kadam, S; Lahn, M; Sayar, H; Schmidt, S; Van Bockstaele, D, 2013
)
0.6
"This study aims to determine the maximum tolerated dose (MTD) of clofarabine combined with the EORTC-GIMEMA 3 + 10 induction regimen (idarubicin + cytosine arabinoside) in adults with untreated acute myelogenous leukemia or high-risk myelodysplastic syndrome."( Clofarabine in combination with a standard remission induction regimen (cytosine arabinoside and idarubicin) in patients with previously untreated intermediate and bad-risk acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): p
Amadori, S; de Witte, T; Halkes, CJ; Karrasch, M; Marie, JP; Meert, L; Meloni, G; Muus, P; Rapion, J; Suciu, S; Vignetti, M; Willemze, R, 2014
)
0.82
"This Phase 2 study tested the tolerability and efficacy of bortezomib combined with reinduction chemotherapy for pediatric patients with relapsed, refractory or secondary acute myeloid leukemia (AML)."( A Phase 2 study of bortezomib combined with either idarubicin/cytarabine or cytarabine/etoposide in children with relapsed, refractory or secondary acute myeloid leukemia: a report from the Children's Oncology Group.
Adlard, K; Alonzo, TA; Ballard, J; Gamis, AS; Gerbing, RB; Horton, TM; Howard, DS; Jenkins, G; Kelder, A; Moscow, JA; Perentesis, JP; Schuurhuis, GJ; Smith, FO, 2014
)
0.65
"Patients with <400 mg/m(2) prior anthracycline received bortezomib combined with idarubicin (12 mg/m(2) days 1-3) and low-dose cytarabine (100 mg/m(2) days 1-7) (Arm A)."( A Phase 2 study of bortezomib combined with either idarubicin/cytarabine or cytarabine/etoposide in children with relapsed, refractory or secondary acute myeloid leukemia: a report from the Children's Oncology Group.
Adlard, K; Alonzo, TA; Ballard, J; Gamis, AS; Gerbing, RB; Horton, TM; Howard, DS; Jenkins, G; Kelder, A; Moscow, JA; Perentesis, JP; Schuurhuis, GJ; Smith, FO, 2014
)
0.88
" A Phase 1 study demonstrated the safety of high dose pravastatin given with idarubicin and cytarabine in patients with AML and also demonstrated an encouraging response rate."( SWOG0919: a Phase 2 study of idarubicin and cytarabine in combination with pravastatin for relapsed acute myeloid leukaemia.
Advani, AS; Appelbaum, FR; Copelan, E; List, AF; McDonough, S; Mulford, DA; Othus, M; Sekeres, MA; Willman, C, 2014
)
0.92
" Our study suggests that the MTD of idarubicin in combination with HD-MTX, VDS, and PRED, should be 16 mg/m(2) ."( A phase 1 dose escalation study of idarubicin combined with methotrexate, vindesine, and prednisolone for untreated elderly patients with primary central nervous system lymphoma. The GOELAMS LCP 99 trial.
Brion, A; Chabin, M; Clavert, A; Colombat, P; Cumin, I; Delwail, V; Escoffre-Barbe, M; Gardembas, M; Ingrand, P; Lacotte-Thierry, L; Legouffe, E; Olivier, G; Solal-Celigny, P, 2014
)
0.95
"This study was aimed to investigate the clinical efficacy of idarubicin combined with methotrexate for treatment of patients with central nervous system diffuse large B-cell lymphoma."( [Clinical efficacy of idarubicin combined with methotrexate for treatment of patients with central nervous system diffuse large B cell lymphoma].
Chen, BA; Xiao, YH; Yu, ZP; Yuan, P; Yue, TH, 2014
)
0.96
"The primary objective of this trial was to assess the feasibility, toxicity profile, and antitumor activity of gemtuzumab ozogamicin (GO) combined with a chemotherapy remission-induction regimen in adults with untreated high-risk myelodysplastic syndrome (HR-MDS) or secondary acute myeloid leukemia (sAML)."( Idarubicin and cytarabine in combination with gemtuzumab ozogamicin (IAGO) for untreated patients with high-risk MDS or AML evolved from MDS: a phase II study from the EORTC and GIMEMA Leukemia Groups (protocol 06013).
Amadori, S; Baron, F; Bron, D; de Witte, T; Halkes, C; Meert, L; Muus, P; Selleslag, D; Suciu, S; Willemze, R, 2015
)
1.86
" A Phase 2 study of high dose pravastatin given in combination with idarubicin and cytarabine demonstrated an impressive response rate [75% complete remission (CR), CR with incomplete count recovery (CRi)]."( Report of the relapsed/refractory cohort of SWOG S0919: A phase 2 study of idarubicin and cytarabine in combination with pravastatin for acute myelogenous leukemia (AML).
Advani, AS; Appelbaum, FR; Erba, HP; Li, H; Liedtke, M; List, AF; Medeiros, BC; Michaelis, LC; O'Dwyer, K; Othus, M, 2018
)
0.95
"To ascertain the efficacy and safety of daunorubicin combined with cytarabine comparing with idarubicin combined with cytarabine as a standard induction therapy for acute Myeloid leukemia by a meta-analysis."( The efficacy and safety of daunorubicin versus idarubicin combined with cytarabine for induction therapy in acute myeloid leukemia: A meta-analysis of randomized clinical trials.
Lu, Y; Wang, H; Wu, Y; Xiao, Q; Xiao, X, 2020
)
1.03
" We evaluated and cross-checked the randomized clinical trials (RCTs) comparing daunorubicin combined with cytarabine (DA) and idarubicin combined with cytarabine (IA) by two reviewers independently according to Cochrane Handbook for Systematic Reviewers of Interventions."( The efficacy and safety of daunorubicin versus idarubicin combined with cytarabine for induction therapy in acute myeloid leukemia: A meta-analysis of randomized clinical trials.
Lu, Y; Wang, H; Wu, Y; Xiao, Q; Xiao, X, 2020
)
1.02
" This phase Ib/II study evaluated the safety and efficacy of fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin combined with the B-cell lymphoma-2 inhibitor venetoclax in ND-AML and R/R-AML."( Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia.
Adeoti, M; Alvarado, Y; Andreeff, M; Borthakur, G; Daver, N; DiNardo, CD; Garcia-Manero, G; Issa, G; Jabbour, E; Jain, N; Kadia, T; Kantarjian, HM; Konopleva, MY; Kornblau, S; Lachowiez, CA; Loghavi, S; Maiti, A; Masarova, L; Montalban Bravo, G; Pemmaraju, N; Ravandi, F; Sasaki, K; Short, NJ; Takahashi, K; Wang, S; Xiao, L; Yilmaz, M, 2021
)
0.83
"The present study aimed to investigate the efficacy and safety for alternate application of all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) combined with idarubicin (IDA)/daunorubicin (DNR) in treatment of acute promyelocytic leukemia (APL)."( Alternate application of all-trans-retinoic acid and arsenic trioxide combined with idarubicin/daunorubicin in treatment of acute promyelocytic leukemia.
Mao, Y; Tang, F; Xu, X; Zhu, X, 2022
)
1.14
" A prospective single-center phase Ib/II study evaluating fludarabine, cytarabine, G-CSF, and idarubicin combined with venetoclax (FLAG-IDA + VEN) in patients with newly diagnosed (ND) or relapsed/refractory AML."( Venetoclax combined with FLAG-IDA induction and consolidation in newly diagnosed acute myeloid leukemia.
Adeoti, M; Alvarado, Y; Andreeff, M; Borthakur, G; Bravo, GM; Daver, N; DiNardo, CD; Garcia-Manero, G; Issa, G; Jabbour, E; Jain, N; Kadia, T; Kantarjian, HM; Konopleva, MY; Kornblau, S; Lachowiez, CA; Loghavi, S; Maiti, A; Masarova, L; Pemmaraju, N; Ravandi, F; Sasaki, K; Short, NJ; Takahashi, K; Wang, SA; Xiao, L; Yilmaz, M, 2022
)
0.94
" We treated 174 consecutive patients with newly diagnosed CBF-AML in a prospective clinical trial of FLAG-based induction/consolidation in combination with gemtuzumab ozogamicin (FLAG-GO; N = 65) or in combination with idarubicin (FLAG-IDA; N = 109)."( Retrospective comparison of survival and responses to Fludarabine, Cytarabine, GCSF (FLAG) in combination with gemtuzumab ozogamicin (GO) or Idarubicin (IDA) in patients with newly diagnosed core binding factor (CBF) acute myelogenous leukemia: MD Anderso
Alvarado, Y; Borthakur, G; Brandt, M; Daver, N; DiNardo, C; Garcia-Manero, G; Jabbour, EJ; Kadia, T; Kantarjian, H; Ohanian, M; Patel, K; Pemmaraju, N; Pierce, S; Ravandi, F; Takahashi, K; Wang, X, 2022
)
1.11
"Venetoclax (VEN) in combination with intensive chemotherapy (IC) is increasingly used to treat patients with high-risk acute myeloid leukemia (AML)."( Safety and efficacy of FLAG-Ida-based therapy combined with venetoclax for the treatment for newly diagnosed and relapsed/refractory patients with AML - A systematic review.
Fredman, D; Gafter-Gvili, A; Raanani, P; Sherban, A; Shimony, S; Stahl, M; Wolach, O; Yeshurun, M, 2023
)
0.91

Bioavailability

The bioavailability of oral idarubicin and of oral doxifluridine allows for their use in an oral 3 drug regimen. The aim of this research was to study whether the bioavailability could be improved by administering IDA-SLN duodenally to rats.

ExcerptReferenceRelevance
" Unlike the other currently available anthracyclines, idarubicin has significant oral bioavailability (average 28%), and an oral dosage form is currently under investigation."( Idarubicin: an anthracycline antineoplastic agent.
Cersosimo, RJ, 1992
)
1.97
" administration of the drug in another study, the bioavailability of idarubicin alone can be estimated to about 21%, whereas the bioavailability of the sum idarubicin + idarubicinol is about 41%."( Pharmacokinetics of idarubicin after oral administration in elderly leukemic patients.
Huet, S; Hurteloup, P; Pris, J; Rigal-Huguet, F; Robert, J, 1990
)
0.84
" dose, and the bioavailability of the oral dose ranged between 9% and 39%."( Pharmacokinetics of 4-demethoxydaunorubicin in cancer patients.
D'Incalci, M; Erranti, D; Freshi, A; Tirelli, U; Zanette, L; Zucchetti, M, 1990
)
0.28
" The bioavailability of DMDR given PO was about 39% according to comparison of the areas under the plasma DMDR concentration versus time curves for the two routes, but 45% according to comparison of the 24-h cumulative urinary excretion rates."( Clinical pharmacology of 4-demethoxydaunorubicin (DMDR).
Bodey, GP; Burgess, M; Feun, LG; Kavanagh, J; Loo, TL; Lu, K; Savaraj, N, 1986
)
0.27
" routes suggests an oral bioavailability of approximately 24%."( Clinical pharmacology of oral and intravenous 4-demethoxydaunorubicin.
Howell, A; Lucas, SB; Margison, JM; Smith, DB; Wilkinson, PM, 1987
)
0.27
" The present study was undertaken to investigate the pharmacokinetics and bioavailability of idarubicin in man."( Pharmacokinetic study of intravenous and oral idarubicin in cancer patients.
Libretti, A; Moro, E; Pacciarini, MA; Piazza, E; Tamassia, V; Vago, G, 1987
)
0.75
"Two anthracycline analogues, idarubicin and menogaril, have acceptable bioavailability via the oral route of administration."( Potential role of oral anthracyclines in older patients with cancer.
de Valeriola, DL; Lasota, WS; Piccart, MJ, 1994
)
0.58
" Unlike the other currently available anthracyclines, IDA has significant oral bioavailability (about 30%)."( [Clinical pharmacology of idarubicin].
Robak, T, 1993
)
0.59
" The bioavailability of oral idarubicin and of oral doxifluridine allows for their use in an oral 3 drug regimen."( Phase II study of an oral combination of doxifluridine, prednimustine and idarubicin (FUPRIDA) for first line treatment of advanced breast cancer.
Alberto, P, 1993
)
0.81
" The bioavailability of idarubicin is 20 to 25%, but if the activity of idarubicinol is taken into account, it is effectively about 40%."( Clinical pharmacokinetics of idarubicin.
Robert, J, 1993
)
0.88
" These perspectives are somewhat hampered by the large variation in bioavailability between individual patients and the obvious requirement to monitor plasma concentration and area-under the curve values (AUC) for an appropriate adjustment of idarubicin dose."( Oral idarubicin pharmacokinetics--correlation of trough level with idarubicin area under curve.
Braess, J; Hiddemann, W; Kaufmann, CC; Kern, W; Kühn, S; Rührs, H; Schleyer, E; Sträubel, G; Unterhalt, M, 1996
)
0.99
" The joint bioavailability of the parent compound and its active metabolite Idarubicinol is around 40%."( [Oral idarubicin in treatment of advanced breast carcinoma].
Heinisch, H; Kerpel-Fronius, S, 1996
)
1
" These perspectives are somewhat hampered by the large variation in bioavailability between individual patients and the obvious requirement to monitor plasma concentration and area-under-the-curve values (AUC) for an appropriate adjustment of idarubicin dose."( Oral idarubicin pharmacokinetics--correlation of trough level with idarubicin area under curve.
Braess, J; Hiddemann, W; Kaufmann, CC; Kern, W; Kühn, S; Rührs, H; Schleyer, E; Sträubel, G; Unterhalt, M, 1997
)
0.99
" The aim of this research was to study whether the bioavailability of idarubicin can be improved by administering IDA-SLN duodenally to rats."( Pharmacokinetics and tissue distribution of idarubicin-loaded solid lipid nanoparticles after duodenal administration to rats.
Bargoni, A; Cavalli, R; Fundarò, A; Gasco, MR; Vighetto, D; Zara, GP, 2002
)
0.81
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34

Dosage Studied

17 patients with APL were salvaged with ATRA at a dosage of 50 mg/m2/day for 3 months or until complete remission (CR) was achieved. idarubicin was added if blast plus promyelocyte count either was or reached > or = 10 x 10(3)/microliters.

ExcerptRelevanceReference
" Unlike the other currently available anthracyclines, idarubicin has significant oral bioavailability (average 28%), and an oral dosage form is currently under investigation."( Idarubicin: an anthracycline antineoplastic agent.
Cersosimo, RJ, 1992
)
1.97
" Median hematological values during the first cycle for this dosage included WBC, 1,300/mm3; platelets, 129,000/mm3; and hemoglobin, 10."( Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.
Case, DC; Crawford, J; Gams, RA; Gerber, MC; Gould, J; Higano, CS; Pruitt, BT; Votaw, ML, 1992
)
0.57
"Eighteen untreated elderly patients (median age 75 years) with non-Hodgkin's lymphoma (NHL) entered a phase II study with oral Idarubicin (4-demethoxidaunorubicin) at a dosage of 30-35 mg/m2 on day 1 and every 3 weeks thereafter."( A phase II study of oral idarubicin (4-demethoxidaunorubicin) in previously untreated elderly patients with non-Hodgkin's lymphoma.
Carbone, A; Errante, D; Monfardini, S; Sorio, R; Tirelli, U; Zagonel, V, 1991
)
0.79
"44 at a cumulative IDA dosage of 322 mg/m2."( Phase II study of oral idarubicin in elderly patients with advanced breast cancer.
Bastit, P; Chevallier, B; Hurteloup, P; Marty, M; Metz, R; Monnier, A; Namer, M; Roche, H, 1990
)
0.59
"Fourteen patients with extensive-disease non-small-cell lung cancer (E-NSCLC) were treated with oral 4-demethoxydaunorubicin (idarubicin, 4DMDR) at a dosage of 10 mg/m2/day x 5 days every 3 weeks."( Phase II study of idarubicin in extensive-disease non-small-cell lung cancer.
Carr, DT; Holoye, PY; Jeffries, D; Umsawasdi, T, 1989
)
0.82
" In order to reduce the incidence of severe complications noted with HDARA-C-containing regimens, we used a combination of intravenous (IV) idarubicin (IDARUB) at optimal dosage and cytarabine (ARA-C) at intermediate dosage."( Treatment of relapsed acute myeloid leukemia with idarubicin and intermediate-dose cytarabine.
Dufour, P; Facon, T; Guy, H; Harousseau, JL; Hurteloup, P; Ifrah, N; Milpied, N; Reiffers, J; Rigal-Huguet, F, 1989
)
0.73
" at a dosage of 600 mg/m2 on the same day as fluorouracil (600 mg/m2/i."( Intravenous administration of cyclophosphamide, methotrexate and 5-fluorouracil in metastatic breast cancer. A pilot study.
Brandi, M; De Lena, M; Logroscino, A; Lorusso, V; Maiello, E; Paradiso, A, 1988
)
0.27
"25 mg/kg body weight or PO at 1 mg/kg body weight, whereas [14C]DNR was dosed IV at 1 mg/kg body weight."( Disposition and metabolism of [14-14C] 4-demethoxydaunorubicin HCl (idarubicin) and [14-14C]daunorubicin HCl in the rat. A comparative study.
Arcamone, F; Lazzati, M; Vicario, GP; Zini, G, 1986
)
0.51
" The drug was given in divided doses over 5 days and dosage was repeated every 3 weeks."( A phase II trial of 4-demethoxydaunorubicin in refractory epithelial ovarian cancer.
Copeland, LJ; Edwards, CL; Gershenson, DM; Kavanagh, JJ; Saul, PB, 1986
)
0.27
"Twelve patients affected by different types of acute leukemia received idarubicin (4-demethoxy-daunorubicin) by oral route at the total dosage of 45, 60 or 90 mg/m2 distributed over three consecutive days."( Oral idarubicin in adult acute leukemia: a preliminary experience.
Annaloro, C; Lambertenghi-Deliliers, G; Pacciarini, MA; Pogliani, E; Polli, EE, 1986
)
1.02
" Cellular D-DNM concentrations were maximal at the end of intravenous dosing and at 2 to 4 hours after D-DNM ingestion."( Plasma and human leukemic cell pharmacokinetics of oral and intravenous 4-demethoxydaunomycin.
Haanen, C; Linssen, PC; Speth, PA; van de Loo, FA; Wessels, HM, 1986
)
0.27
" Since there was no severe toxicity, after 2 cycles the dosage was increased to 60 mg/m2 per cycle."( Phase II study of oral 4-demethoxydaunorubicin in previously treated (except anthracyclines) metastatic breast cancer patients.
Kolarić, K; Mechl, Z; Potrebica, V; Sopkova, B, 1987
)
0.27
" A group of 16 patients in relapse received idarubicin at a dosage of 5-6 mg/m2/day for 3 consecutive days; a second group of 6 relapsing and 4 previously untreated cases was treated with a sequential combination of idarubicin and arabinosyl cytosine."( Therapeutic activity of 4-demethoxydauno-rubicin (idarubicin) in adult acute leukemia.
Lambertenghi-Deliliers, G; Maiolo, AT; Pacciarini, MA; Pogliani, E; Polli, EE, 1983
)
0.78
" Dose-response curves for AML blast cells were characterized by an initial shoulder and then an exponential decrease in survival."( Sensitivities of AML blast stem cells to idarubicin and daunorubicin: a comparison with normal hematopoietic progenitors.
Curtis, JE; McCulloch, EA; Minden, MD; Minkin, S, 1995
)
0.56
" The maximum tolerated dosage was determined to be 2 mg/cat/d given for 3 consecutive days every 3 weeks."( Efficacy of, and toxicoses associated with, oral idarubicin administration in cats with neoplasia.
Cotter, SM; L'Heureux, DA; Moore, AS; Rand, WM; Ruslander, D, 1995
)
0.55
" These studies should address specific issues such as optimal dosage regimens as a function of 'physiological age', and quality of life."( Potential role of oral anthracyclines in older patients with cancer.
de Valeriola, DL; Lasota, WS; Piccart, MJ, 1994
)
0.29
"Seventeen patients with APL were salvaged with ATRA at a dosage of 50 mg/m2/day for 3 months or until complete remission (CR) was achieved; idarubicin (12 mg/m2/day for 4 days) was added if blast plus promyelocyte count either was or reached > or = 10 x 10(3)/microliters."( All-trans retinoic acid followed by chemotherapy for salvage of refractory or relapsed acute promyelocytic leukemia.
Cortes, JE; Estey, E; Hirsh-Ginsberg, C; Kantarjian, H; Keating, M; Koller, C; O'Brien, S; Robertson, LE; Stass, S, 1994
)
0.49
" For consolidation with NOVE, rhGM-CSF was given according to the same dosage schedule."( Idarubicin/cytosine arabinoside and mitoxantrone/etoposide for the treatment of de novo acute myelogenous leukemia.
Del Valle, F; Döhner, H; Ehrhardt, R; Fischer, JT; Haas, R; Ho, AD; Huberts, H; Hunstein, W; Kaplan, E; Witt, B, 1993
)
1.73
"The influence of three different dosage schedules of anthracycline (idarubicin or daunorubicin)-intensified preparative therapy prior to T-cell-depleted allogeneic bone marrow transplantation (BMT) on (1) the severity and duration of oral toxicity (mucositis), (2) the duration of bone marrow aplasia, and (3) overall survival, relapse, and disease-free survival was studied in 99 BMT patients with standard- or high-risk hematologic malignancies."( Idarubicin-related side effects in recipients of T-cell-depleted allogeneic bone marrow transplants are schedule dependent.
de Witte, T; Dompeling, E; Donnelly, P; Linssen, P; Minderman, H; Muus, P; Schattenberg, A, 1993
)
1.96
" Median hematologic values during the first cycle for this dosage included WBC 1300/mm3, platelets 129,000/mm3, and hemoglobin 10."( Phase II study of intravenous idarubicin in unfavorable non-Hodgkin's lymphoma.
Case, DC; Crawford, J; Gams, RA; Gerber, MC; Gould, J; Higano, CS; Pruitt, BT; Votaw, ML, 1993
)
0.57
" The result indicated that Idarubicin is a useful drug for the treatment of acute leukemia, and the clinical optimal dosage estimated was either 10 mg/m2 or 12 mg/m2 once daily for 3 consecutive days."( [Early phase II study of Idarubicin, a new anthracycline anticancer drug, in acute leukemia. Idarubicin Study Group].
Kimura, K; Masaoka, T; Ogawa, M; Yamada, K, 1993
)
0.89
" Considering effectiveness and safety, the clinical optimal dosage of Idarubicin when used concomitantly with Cytarabine was judged to be 12 mg/m2 once daily for 3 consecutive days."( [Early phase II study of Idarubicin combined with cytarabine in acute myelogenous leukemia. Idarubicin Study Group].
Kimura, K; Masaoka, T; Ogawa, M; Yamada, K, 1993
)
0.82
" In acute lymphoblastic leukemia (ALL), the role of agreement regarding ANT dosage and schedule, preferable compound, and indications for remission induction and consolidation treatment phases."( Role of anthracyclines in the treatment of adult acute lymphoblastic leukemia.
Barbui, T; Bassan, R; Lerede, T; Rambaldi, A, 1996
)
0.29
" ATRA was administered orally beginning on the first day of induction at the dosage of 45 mg/m2/d until complete remission (CR), whereas IDA was administered intravenously at the dosage of 12 mg/m2/d on days 2, 4, 6, and 8 of the induction."( AIDA (all-trans retinoic acid + idarubicin) in newly diagnosed acute promyelocytic leukemia: a Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) pilot study.
Avvisati, G; Diverio, D; Falda, M; Ferrara, F; Lazzarino, M; Lo Coco, F; Mandelli, F; Petti, MC; Russo, D, 1996
)
0.58
" When IDA was administered at this dosage or higher, there were three CRs and four partial responses, with an overall response rate of 26."( A phase I study of idarubicin hydrochloride in patients with acute leukemia. The Idarubicin Study Group of Japan.
Tamura, K, 1996
)
0.62
") over 30 minutes daily on days 1 to 3, in combination with BH-AC 300 mg/m2 over 4 hours daily on days 1 to 7 (in patients aged 41 to 65 years, BH-AC dosage was decreased to 200 mg/m2/d)."( Induction chemotherapy with idarubicin plus N4-behenoyl-1-beta-D-arabinofuranosylcytosine in acute myelogenous leukemia: a newly designed induction regimen--a prospective, cooperative multicenter study.
Ahn, HS; Cho, KS; Choi, YM; Chung, TJ; Hwang, TJ; Kim, CC; Kim, DW; Kim, HJ; Kim, HK; Kim, HS; Kim, JS; Lee, KS; Park, HS; Park, JW; Song, HS, 1996
)
0.59
" IDA is bioavailable in an oral dosage form."( Pharmacology of chronic oral daily administration of idarubicin.
Aita, P; Bearz, A; Boiocchi, M; Corona, G; Crivellari, D; Rimondi, G; Robieux, I; Sorio, R; Stocco, F; Toffoli, G,
)
0.38
" The data suggest a dose-response relationship for increasing doses of idarubicin with 0/3 complete responses (CR) at 20 mg/m2, 1/3 CR at 30 mg/m2, and 7/12 (58%) CR at idarubicin doses > or = 40 mg/m2."( A phase I trial of a single high dose of idarubicin combined with high-dose cytarabine as induction therapy in relapsed or refractory adult patients with acute lymphoblastic leukemia.
Drullinsky, P; Golde, DW; Maslak, P; Scheinberg, D; Weiss, MA, 1998
)
0.8
" These adverse effects might be overcome by increasing the intensity of postremission therapy and modifying the dosing schedule."( Remission induction therapy of untreated acute myeloid leukemia using a non-cytarabine-containing regimen of idarubicin, etoposide, and carboplatin.
Bow, EJ; Gallant, G; Rubinger, M; Schacter, BA; Shore, TB; Williams, GJ; Woloschuk, D, 1998
)
0.51
" In older patients (> 60 years) the dosage of idarubicin and ifosfamide was reduced to 75% in the initial cycle."( DIZE (dexamethasone, idarubicin, and continuous infusion of ifosfamide and etoposide): an effective and well-tolerated new regimen for patients with relapsed lymphoma.
Borchmann, P; Diehl, V; Engert, A; Münch, R; Reiser, M; Schnell, R; Straub, G; Ubelacker, R; Wilhelm, M; Wörmann, B, 1998
)
0.88
" Our findings raise important questions concerning the need for a dosage adjustment of IDA when MDR modulators are coadministered."( Multidrug resistance modulation in vivo: the effect of cyclosporin A alone or with dexverapamil on idarubicin pharmacokinetics in acute leukemia.
Baccarani, M; Baraldo, M; Damiani, D; Ermacora, A; Fanin, R; Furlanut, M; Michieli, M; Pea, F; Russo, D, 1999
)
0.52
" bolus, and this dosage regimen was repeated every 3 weeks."( [Clinical effect of idarubicin on malignant lymphoma].
Kuraishi, Y; Masaoka, T; Ogawa, M; Ohashi, Y; Ohno, R; Urabe, A, 1999
)
0.63
" Cytarabine was given to Cohort 1 at the conventional dosage of 100 mg/m2 per day by continuous infusion for 7 days in induction and 5 days in consolidation; to Cohort 2 at high-dose (HiDAC) (3 g/m2 intravenously twice daily on days 1, 3, 5 and 7) during induction with conventional dosage during consolidation; to Cohort 3 HiDAC was given for both induction and consolidation."( A phase I/II study of intensive dose escalation of cytarabine in combination with idarubicin and etoposide in induction and consolidation treatment of adult acute myeloid leukemia. Australian Leukaemia Study Group (ALSG).
Bishop, JF; Bradstock, KF; Cobcroft, R; Eliadis, P; Enno, A; Gill, D; Herrmann, RP; Juneja, S; Lowenthal, RM; Manoharan, A; Matthews, JP; Page, FJ; Rooney, KF; Rosenfeld, D; Seldon, M; Taylor, KM; Wolf, MM; Young, GA, 1999
)
0.53
" We conclude that CBP at a cumulative dosage of 1 g/m2 together with intercalating agents (IDA/MIT) has antileukemic efficacy in elderly patients."( Continuous-infusion carboplatin in combination with idarubicin or mitoxantrone for high-risk acute myeloid leukemia: a randomised phase II study.
Archimbaud, E; Assouline, D; Belhabri, A; Blanc, M; Fière, D; Michallet, M; Thomas, X; Tigaud, JD; Troncy, J; Wattel, E, 1999
)
0.55
"These data confirm the existence of a saturable myocardial uptake mechanism for idarubicin and might provide useful information for optimizing anthracycline dosage regiments."( Kinetic analysis of saturable myocardial uptake of idarubicin in rat heart: effect of doxorubicin and hypothermia.
Kang, W; Weiss, M, 2003
)
0.8
" The dosage of the immune suppressive reagents that were administered to prevent the rejection of the transplanted kidney were reduced during chemotherapy to minimize the adverse effect of immune suppression, and G-CSF was administrated to shorten the neutropenic period."( [Intensive multi-drug chemotherapy for acute myeloid leukemia in a renal allograft recipient].
Fuchigami, K; Fukushima, T; Hata, T; Honda, M; Jinnai, I; Kuriyama, K; Miyazaki, Y; Togami, K; Tomonaga, M; Yamasaki, J, 2003
)
0.32
"Six-month intravenous chemotherapy included carboplatin plus etoposide alternating with cyclophosphamide plus vincristine (Regimen 1) and the same drugs at higher dosage plus idarubicin (Regimen 2)."( Results of a prospective study for the treatment of retinoblastoma.
Casak, S; Chantada, G; Dávila, MT; Fandiño, A; Manzitti, J; Raslawski, E; Schvartzman, E, 2004
)
0.52
" Following complete staging after course 2, radiotherapy was applied at a dosage of 3600-4140 cGy in conventional schedule (180 or 200 cGy per day) to whole brain (with 3600 cGy to eyes in one case because of eye involvement) and then 2 additional courses of R-IDARAM (totally four courses) chemotherapy regimen were applied."( Modified IDARAM chemotherapy regimen for primary central nervous system lymphoma: experience of three cases.
Alptekin, M; Erkutlu, I; Kilciksiz, S; Okan, V; Pehlivan, M; Sari, I; Yilmaz, M, 2008
)
0.35
" Clofarabine dosed at 52 mg/m2 was used in adult patients with refractory ALL to maximize response before allo-HSCT."( The use of higher dose clofarabine in adults with relapsed acute lymphoblastic leukemia.
Brown, AW; McGregor, BA; Osswald, MB; Savona, MR, 2009
)
0.35
" LY2181308 was administered with a loading dosage of three consecutive daily infusions of 750 mg followed by weekly intravenous (IV) maintenance doses of 750 mg."( Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML).
Andre, V; Andreeff, M; Brandt, JT; Callies, S; Erba, HP; Juckett, M; Kadam, S; Lahn, M; Sayar, H; Schmidt, S; Van Bockstaele, D, 2013
)
0.6
"This systematic review and meta-analysis compared the efficacy of different anthracyclines and anthracycline dosing schedules for induction therapy in acute myeloid leukaemia in children and adults younger than 60 years of age."( Anthracyclines during induction therapy in acute myeloid leukaemia: a systematic review and meta-analysis.
Alonzo, TA; Beyene, J; Lehrnbecher, T; Leibundgut, K; Sung, L; Teuffel, O, 2013
)
0.39
" To further intensify anthracycline dosage without increasing cardiotoxicity, we compared potentially less cardiotoxic liposomal daunorubicin (L-DNR) to idarubicin at a higher-than-equivalent dose (80 vs 12 mg/m(2) per day for 3 days) during induction."( Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004.
Bourquin, JP; Creutzig, U; Dworzak, MN; Fleischhack, G; Graf, N; Klingebiel, T; Kremens, B; Lehrnbecher, T; Reinhardt, D; Ritter, J; Sander, A; Schrauder, A; Starý, J; von Neuhoff, C; von Stackelberg, A; Zimmermann, M, 2013
)
0.84
" Using TR-FRET, we screened the Sigma LOPAC library for MBD2-MBD inhibitors and identified four compounds that also validated in a dose-response series."( Time-Resolved Fluorescence Resonance Energy Transfer Assay for Discovery of Small-Molecule Inhibitors of Methyl-CpG Binding Domain Protein 2.
Giovinazzo, H; Nelson, WG; Walker, D; Wyhs, N; Yegnasubramanian, S, 2014
)
0.4
" After six cycles of R-IDARAM at 3-weekly intervals, radiotherapy was applied at a dosage of 2000-4000 cGy in conventional schedule (180 or 200 cGy/day) to whole brain or spinal cord in all patients."( Combined treatment of rituximab, idarubicin, dexamethasone, cytarabine, methotrexate with radiotherapy for primary central nervous system lymphoma.
Cen, J; Li, C; Liu, X; Ma, Y; Mei, K; Qian, L; Shen, J; Wang, Y; Zhao, D, 2014
)
0.68
" Therefore, in study AML-BFM 2004 we aimed to improve outcome of HR-patients by adding moderately dosed 2-Chloro-2-Deoxyadenosine (2-CDA) to the respective consolidation treatment backbone without increasing toxicity."( Randomised Introduction of 2-CDA as Intensification during Consolidation for Children with High-risk AML--results from Study AML-BFM 2004.
Bourquin, JP; Creutzig, U; Dworzak, M; Fleischhack, G; Graf, N; Gruhn, B; Klingebiel, T; Kremens, B; Lehrnbecher, T; Reinhardt, D; Stray, J; von Neuhoff, C; von Stackelberg, A; Zimmermann, M, 2015
)
0.42
" Fourteen patients were included, and selinexor dosage was 60 mg (3 patients), 80 mg (3 patients), and 100 mg (7 patients) weekly."( A phase I trial of selinexor plus FLAG-Ida for the treatment of refractory/relapsed adult acute myeloid leukemia patients.
Acuña-Cruz, E; Barragán, E; Bergua, JM; Boluda, B; Cano-Ferri, I; Martín-Herreros, B; Martínez Sánchez, MP; Martínez-Cuadrón, D; Martínez-López, J; Megías-Vericat, JE; Montesinos, P; Rodríguez-Veiga, R; Sanz, M; Sargas, C; Sempere, A; Serrano, A; Suárez-Varela, S; Torrent, A; Torres-Miñana, L; Vives, S, 2021
)
0.62
" Compared with RATIFY, this study extended midostaurin treatment from 14 days to 21 days, substituted anthracyclines (idarubicin or daunorubicin), and introduced variation in standard combination chemotherapy dosing ("7+3" or "5+2" in more fragile patients)."( Midostaurin plus daunorubicin or idarubicin for young and older adults with FLT3-mutated AML: a phase 3b trial.
Bengoudifa, BR; Caillot, D; Cluzeau, T; Farkas, F; Gilotti, G; Griskevicius, L; Hodzic, S; Legrand, O; Luppi, M; Minotti, C; Montesinos, P; Rambaldi, A; Sierra, J; Thomas, X; Venditti, A, 2023
)
1.4
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (3)

ClassDescription
anthracycline antibioticAn organic compound that has a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine and which exhibits antibiotic activity.
deoxy hexoside
monosaccharide derivativeA carbohydrate derivative that is formally obtained from a monosaccharide.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (62)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency13.18630.003245.467312,589.2998AID1705; AID2517; AID2572; AID2573
Chain A, 2-oxoglutarate OxygenaseHomo sapiens (human)Potency14.12540.177814.390939.8107AID2147
Chain A, ATP-DEPENDENT DNA HELICASE Q1Homo sapiens (human)Potency24.96180.125919.1169125.8920AID2353; AID2549; AID2708
Chain A, Ferritin light chainEquus caballus (horse)Potency39.81075.623417.292931.6228AID2323
endonuclease IVEscherichia coliPotency25.11890.707912.432431.6228AID1708
thioredoxin reductaseRattus norvegicus (Norway rat)Potency26.67950.100020.879379.4328AID488773; AID588453
ATAD5 protein, partialHomo sapiens (human)Potency3.19130.004110.890331.5287AID493106; AID493107
USP1 protein, partialHomo sapiens (human)Potency44.96470.031637.5844354.8130AID504865
PPM1D proteinHomo sapiens (human)Potency2.08210.00529.466132.9993AID1347411
Microtubule-associated protein tauHomo sapiens (human)Potency8.06870.180013.557439.8107AID1460; AID1468
DNA polymerase III, partialBacillus subtilisPotency1.06211.062114.152826.6795AID485295
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency28.18380.011212.4002100.0000AID1030
regulator of G-protein signaling 4Homo sapiens (human)Potency37.68580.531815.435837.6858AID504845
nonstructural protein 1Influenza A virus (A/WSN/1933(H1N1))Potency39.81070.28189.721235.4813AID2326
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency0.87680.001530.607315,848.9004AID1224819; AID1224820; AID1224821; AID1224823
ParkinHomo sapiens (human)Potency5.80480.819914.830644.6684AID720573
arylsulfatase AHomo sapiens (human)Potency11.99551.069113.955137.9330AID720538
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency9.70770.035520.977089.1251AID504332
Bloom syndrome protein isoform 1Homo sapiens (human)Potency10.54680.540617.639296.1227AID2364; AID2528; AID2585
hexokinase-4 isoform 1Homo sapiens (human)Potency0.70792.511913.800328.1838AID743205
NPC intracellular cholesterol transporter 1 precursorHomo sapiens (human)Potency115.82100.01262.451825.0177AID485313
peripheral myelin protein 22 isoform 1Homo sapiens (human)Potency0.425623.934123.934123.9341AID1967
D(1A) dopamine receptorHomo sapiens (human)Potency8.44980.02245.944922.3872AID488981; AID488982; AID488983
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency7.61110.354828.065989.1251AID504847
chromobox protein homolog 1Homo sapiens (human)Potency39.81070.006026.168889.1251AID488953
thyroid hormone receptor beta isoform aHomo sapiens (human)Potency36.42610.010039.53711,122.0200AID1469; AID1479
potassium voltage-gated channel subfamily H member 2 isoform dHomo sapiens (human)Potency10.00000.01789.637444.6684AID588834
glucokinase regulatory proteinHomo sapiens (human)Potency0.70792.511913.800328.1838AID743205
huntingtin isoform 2Homo sapiens (human)Potency0.63100.000618.41981,122.0200AID1688
DNA polymerase betaHomo sapiens (human)Potency14.12540.022421.010289.1251AID485314
mitogen-activated protein kinase 1Homo sapiens (human)Potency22.38720.039816.784239.8107AID1454
flap endonuclease 1Homo sapiens (human)Potency26.67950.133725.412989.1251AID488816; AID588795
ubiquitin carboxyl-terminal hydrolase 2 isoform aHomo sapiens (human)Potency16.48160.65619.452025.1189AID463106
ras-related protein Rab-9AHomo sapiens (human)Potency58.04790.00022.621531.4954AID485297
serine/threonine-protein kinase mTOR isoform 1Homo sapiens (human)Potency6.20240.00378.618923.2809AID2660; AID2666; AID2667; AID2668
eyes absent homolog 2 isoform aHomo sapiens (human)Potency125.89201.199814.641950.1187AID488837
histone-lysine N-methyltransferase 2A isoform 2 precursorHomo sapiens (human)Potency29.88160.010323.856763.0957AID2662
peptidyl-prolyl cis-trans isomerase NIMA-interacting 1Homo sapiens (human)Potency26.85450.425612.059128.1838AID504536
tumor susceptibility gene 101 proteinHomo sapiens (human)Potency7.94330.129810.833132.6090AID485342
DNA polymerase eta isoform 1Homo sapiens (human)Potency14.12540.100028.9256213.3130AID588591
DNA polymerase iota isoform a (long)Homo sapiens (human)Potency7.94330.050127.073689.1251AID588590
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency17.78280.00798.23321,122.0200AID2551
gemininHomo sapiens (human)Potency15.54410.004611.374133.4983AID463097; AID504364
DNA polymerase kappa isoform 1Homo sapiens (human)Potency17.31140.031622.3146100.0000AID588579
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency1.65980.005612.367736.1254AID624032; AID624044
survival motor neuron protein isoform dHomo sapiens (human)Potency0.63100.125912.234435.4813AID1458
M-phase phosphoprotein 8Homo sapiens (human)Potency29.05940.177824.735279.4328AID488949
muscleblind-like protein 1 isoform 1Homo sapiens (human)Potency7.94330.00419.962528.1838AID2675
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency22.38720.251215.843239.8107AID504327
lamin isoform A-delta10Homo sapiens (human)Potency0.28370.891312.067628.1838AID1459; AID1487
Interferon betaHomo sapiens (human)Potency2.08210.00339.158239.8107AID1347411
Glutamate receptor 1Rattus norvegicus (Norway rat)Potency15.84890.01418.602439.8107AID2572
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency15.84890.001551.739315,848.9004AID2572
Glutamate receptor 3Rattus norvegicus (Norway rat)Potency15.84890.01418.602439.8107AID2572
Glutamate receptor 4Rattus norvegicus (Norway rat)Potency15.84890.01418.602439.8107AID2572
D(1A) dopamine receptorSus scrofa (pig)Potency0.41400.00378.108123.2809AID2667
Inositol monophosphatase 1Rattus norvegicus (Norway rat)Potency1.99531.000010.475628.1838AID1457
Ataxin-2Homo sapiens (human)Potency0.10000.011912.222168.7989AID588378
Single-stranded DNA cytosine deaminaseHomo sapiens (human)Potency67.154528.183860.145389.1251AID1347430; AID1347431
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency30.13130.060110.745337.9330AID485368
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
NPYLR7BAedes aegypti (yellow fever mosquito)EC50 (µMol)4.29000.03902.289918.3000AID1259426
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (125)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
cognitionAmyloid-beta precursor proteinHomo sapiens (human)
G2/M transition of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
microglial cell activationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of protein phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
suckling behaviorAmyloid-beta precursor proteinHomo sapiens (human)
astrocyte activation involved in immune responseAmyloid-beta precursor proteinHomo sapiens (human)
regulation of translationAmyloid-beta precursor proteinHomo sapiens (human)
protein phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
intracellular copper ion homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
endocytosisAmyloid-beta precursor proteinHomo sapiens (human)
response to oxidative stressAmyloid-beta precursor proteinHomo sapiens (human)
cell adhesionAmyloid-beta precursor proteinHomo sapiens (human)
regulation of epidermal growth factor-activated receptor activityAmyloid-beta precursor proteinHomo sapiens (human)
Notch signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
axonogenesisAmyloid-beta precursor proteinHomo sapiens (human)
learning or memoryAmyloid-beta precursor proteinHomo sapiens (human)
learningAmyloid-beta precursor proteinHomo sapiens (human)
mating behaviorAmyloid-beta precursor proteinHomo sapiens (human)
locomotory behaviorAmyloid-beta precursor proteinHomo sapiens (human)
axo-dendritic transportAmyloid-beta precursor proteinHomo sapiens (human)
cholesterol metabolic processAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of cell population proliferationAmyloid-beta precursor proteinHomo sapiens (human)
adult locomotory behaviorAmyloid-beta precursor proteinHomo sapiens (human)
visual learningAmyloid-beta precursor proteinHomo sapiens (human)
regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of gene expressionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of peptidyl-threonine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of G2/M transition of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
microglia developmentAmyloid-beta precursor proteinHomo sapiens (human)
axon midline choice point recognitionAmyloid-beta precursor proteinHomo sapiens (human)
neuron remodelingAmyloid-beta precursor proteinHomo sapiens (human)
dendrite developmentAmyloid-beta precursor proteinHomo sapiens (human)
regulation of Wnt signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
extracellular matrix organizationAmyloid-beta precursor proteinHomo sapiens (human)
forebrain developmentAmyloid-beta precursor proteinHomo sapiens (human)
neuron projection developmentAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of chemokine productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of interleukin-1 beta productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of interleukin-6 productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of tumor necrosis factor productionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
ionotropic glutamate receptor signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
regulation of multicellular organism growthAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of neuron differentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of glycolytic processAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of mitotic cell cycleAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of JNK cascadeAmyloid-beta precursor proteinHomo sapiens (human)
astrocyte activationAmyloid-beta precursor proteinHomo sapiens (human)
regulation of long-term neuronal synaptic plasticityAmyloid-beta precursor proteinHomo sapiens (human)
collateral sprouting in absence of injuryAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of inflammatory responseAmyloid-beta precursor proteinHomo sapiens (human)
regulation of peptidyl-tyrosine phosphorylationAmyloid-beta precursor proteinHomo sapiens (human)
regulation of synapse structure or activityAmyloid-beta precursor proteinHomo sapiens (human)
synapse organizationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of calcium-mediated signalingAmyloid-beta precursor proteinHomo sapiens (human)
neuromuscular process controlling balanceAmyloid-beta precursor proteinHomo sapiens (human)
synaptic assembly at neuromuscular junctionAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of protein metabolic processAmyloid-beta precursor proteinHomo sapiens (human)
neuron apoptotic processAmyloid-beta precursor proteinHomo sapiens (human)
smooth endoplasmic reticulum calcium ion homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
neuron cellular homeostasisAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeAmyloid-beta precursor proteinHomo sapiens (human)
response to interleukin-1Amyloid-beta precursor proteinHomo sapiens (human)
modulation of excitatory postsynaptic potentialAmyloid-beta precursor proteinHomo sapiens (human)
NMDA selective glutamate receptor signaling pathwayAmyloid-beta precursor proteinHomo sapiens (human)
regulation of spontaneous synaptic transmissionAmyloid-beta precursor proteinHomo sapiens (human)
cytosolic mRNA polyadenylationAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of long-term synaptic potentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of long-term synaptic potentiationAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of non-canonical NF-kappaB signal transductionAmyloid-beta precursor proteinHomo sapiens (human)
cellular response to amyloid-betaAmyloid-beta precursor proteinHomo sapiens (human)
regulation of presynapse assemblyAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of amyloid fibril formationAmyloid-beta precursor proteinHomo sapiens (human)
amyloid fibril formationAmyloid-beta precursor proteinHomo sapiens (human)
neuron projection maintenanceAmyloid-beta precursor proteinHomo sapiens (human)
positive regulation of T cell migrationAmyloid-beta precursor proteinHomo sapiens (human)
central nervous system developmentAmyloid-beta precursor proteinHomo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
mRNA processingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cytidine deaminationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
somatic diversification of immunoglobulinsSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
somatic hypermutation of immunoglobulin genesSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
B cell differentiationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
regulation of nuclear cell cycle DNA replicationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
defense response to bacteriumSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
positive regulation of gene expression via chromosomal CpG island demethylationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
isotype switchingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cellular response to lipopolysaccharideSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
DNA cytosine deaminationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
DNA demethylationSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cytidine to uridine editingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
negative regulation of single stranded viral RNA replication via double stranded DNA intermediateSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
defense response to virusSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (23)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingAmyloid-beta precursor proteinHomo sapiens (human)
DNA bindingAmyloid-beta precursor proteinHomo sapiens (human)
serine-type endopeptidase inhibitor activityAmyloid-beta precursor proteinHomo sapiens (human)
signaling receptor bindingAmyloid-beta precursor proteinHomo sapiens (human)
protein bindingAmyloid-beta precursor proteinHomo sapiens (human)
heparin bindingAmyloid-beta precursor proteinHomo sapiens (human)
enzyme bindingAmyloid-beta precursor proteinHomo sapiens (human)
identical protein bindingAmyloid-beta precursor proteinHomo sapiens (human)
transition metal ion bindingAmyloid-beta precursor proteinHomo sapiens (human)
receptor ligand activityAmyloid-beta precursor proteinHomo sapiens (human)
PTB domain bindingAmyloid-beta precursor proteinHomo sapiens (human)
protein serine/threonine kinase bindingAmyloid-beta precursor proteinHomo sapiens (human)
signaling receptor activator activityAmyloid-beta precursor proteinHomo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
cytidine deaminase activitySingle-stranded DNA cytosine deaminaseHomo sapiens (human)
protein bindingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
zinc ion bindingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
ubiquitin protein ligase bindingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
identical protein bindingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
RNA bindingSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (47)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
extracellular spaceAmyloid-beta precursor proteinHomo sapiens (human)
dendriteAmyloid-beta precursor proteinHomo sapiens (human)
extracellular regionAmyloid-beta precursor proteinHomo sapiens (human)
extracellular spaceAmyloid-beta precursor proteinHomo sapiens (human)
nuclear envelope lumenAmyloid-beta precursor proteinHomo sapiens (human)
cytoplasmAmyloid-beta precursor proteinHomo sapiens (human)
mitochondrial inner membraneAmyloid-beta precursor proteinHomo sapiens (human)
endosomeAmyloid-beta precursor proteinHomo sapiens (human)
early endosomeAmyloid-beta precursor proteinHomo sapiens (human)
endoplasmic reticulumAmyloid-beta precursor proteinHomo sapiens (human)
endoplasmic reticulum lumenAmyloid-beta precursor proteinHomo sapiens (human)
smooth endoplasmic reticulumAmyloid-beta precursor proteinHomo sapiens (human)
Golgi apparatusAmyloid-beta precursor proteinHomo sapiens (human)
Golgi lumenAmyloid-beta precursor proteinHomo sapiens (human)
Golgi-associated vesicleAmyloid-beta precursor proteinHomo sapiens (human)
cytosolAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneAmyloid-beta precursor proteinHomo sapiens (human)
clathrin-coated pitAmyloid-beta precursor proteinHomo sapiens (human)
cell-cell junctionAmyloid-beta precursor proteinHomo sapiens (human)
synaptic vesicleAmyloid-beta precursor proteinHomo sapiens (human)
cell surfaceAmyloid-beta precursor proteinHomo sapiens (human)
membraneAmyloid-beta precursor proteinHomo sapiens (human)
COPII-coated ER to Golgi transport vesicleAmyloid-beta precursor proteinHomo sapiens (human)
axonAmyloid-beta precursor proteinHomo sapiens (human)
growth coneAmyloid-beta precursor proteinHomo sapiens (human)
platelet alpha granule lumenAmyloid-beta precursor proteinHomo sapiens (human)
neuromuscular junctionAmyloid-beta precursor proteinHomo sapiens (human)
endosome lumenAmyloid-beta precursor proteinHomo sapiens (human)
trans-Golgi network membraneAmyloid-beta precursor proteinHomo sapiens (human)
ciliary rootletAmyloid-beta precursor proteinHomo sapiens (human)
dendritic spineAmyloid-beta precursor proteinHomo sapiens (human)
dendritic shaftAmyloid-beta precursor proteinHomo sapiens (human)
perikaryonAmyloid-beta precursor proteinHomo sapiens (human)
membrane raftAmyloid-beta precursor proteinHomo sapiens (human)
apical part of cellAmyloid-beta precursor proteinHomo sapiens (human)
synapseAmyloid-beta precursor proteinHomo sapiens (human)
perinuclear region of cytoplasmAmyloid-beta precursor proteinHomo sapiens (human)
presynaptic active zoneAmyloid-beta precursor proteinHomo sapiens (human)
spindle midzoneAmyloid-beta precursor proteinHomo sapiens (human)
recycling endosomeAmyloid-beta precursor proteinHomo sapiens (human)
extracellular exosomeAmyloid-beta precursor proteinHomo sapiens (human)
receptor complexAmyloid-beta precursor proteinHomo sapiens (human)
early endosomeAmyloid-beta precursor proteinHomo sapiens (human)
membrane raftAmyloid-beta precursor proteinHomo sapiens (human)
cell surfaceAmyloid-beta precursor proteinHomo sapiens (human)
Golgi apparatusAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneAmyloid-beta precursor proteinHomo sapiens (human)
plasma membraneGlutamate receptor 1Rattus norvegicus (Norway rat)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
nucleusSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cytoplasmSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cytosolSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
protein-containing complexSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
nucleusSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
cytoplasmSingle-stranded DNA cytosine deaminaseHomo sapiens (human)
P-bodySingle-stranded DNA cytosine deaminaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (122)

Assay IDTitleYearJournalArticle
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID95000Cytotoxic activity against K562 erythroleukemic cells1999Journal of medicinal chemistry, Jul-29, Volume: 42, Issue:15
Solution structure of iron(III)-anthracycline complexes.
AID731882Cytotoxicity against human ES2 cells after 24 hrs by XTT assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID524791Antiplasmodial activity against Plasmodium falciparum 7G8 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID562245Antimycobacterial activity against Mycobacterium smegmatis grown in nitrogen -limited broth medium assessed as growth inhibition in mid-logarithmic phase by GFP-based fluorescence assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID524796Antiplasmodial activity against Plasmodium falciparum W2 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID731877Displacement of YOYO1 from phage lambda DNA by FID assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1678479Inhibition of recombinant His6-tagged SARS-CoV-2 main protease using Dabcyl-KTSAVLQ-SGFRKM-E(Edans-NH2) as substrate preincubated for 15 mins followed by substrate addition by FRET based assay2020ACS medicinal chemistry letters, Dec-10, Volume: 11, Issue:12
Identification of 14 Known Drugs as Inhibitors of the Main Protease of SARS-CoV-2.
AID524795Antiplasmodial activity against Plasmodium falciparum HB3 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID562241Antimycobacterial activity against Mycobacterium smegmatis grown in carbon-limited broth medium assessed as growth inhibition in mid-logarithmic phase by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID562243Antimycobacterial activity against Mycobacterium smegmatis grown in Luria-Bertani broth medium assessed as growth inhibition in mid-logarithmic phase by GFP-based fluorescence assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID524793Antiplasmodial activity against Plasmodium falciparum Dd2 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID681288TP_TRANSPORTER: inhibition of DNP-SG uptake (DNP-SG: 0.01 uM, Idarbicin: 10 uM) in membrane vesicles from GLC4/ADR cells1997Biochimica et biophysica acta, May-22, Volume: 1326, Issue:1
Anthracyclines modulate multidrug resistance protein (MRP) mediated organic anion transport.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1678478Inhibition of recombinant His6-tagged SARS-CoV-2 main protease assessed as residual enzyme activity at 100 uM using Dabcyl-KTSAVLQ-SGFRKM-E(Edans-NH2) as substrate preincubated for 15 mins followed by substrate addition by FRET based assay relative to con2020ACS medicinal chemistry letters, Dec-10, Volume: 11, Issue:12
Identification of 14 Known Drugs as Inhibitors of the Main Protease of SARS-CoV-2.
AID685503HARVARD: Inhibition of blood stage Plasmodium falciparum Dd2 infection2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID562244Antimycobacterial activity against Mycobacterium smegmatis grown in carbon-limited broth medium assessed as growth inhibition in mid-logarithmic phase by GFP-based fluorescence assay2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID731885Cytotoxicity against human MCF7 cells after 24 hrs by XTT assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID731878Cytotoxicity against mouse DA-3 cells assessed as reduction in cell viability at 20 uM by XTT assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID731874Ratio of idarubicin IC50 to compound IC50 for displacement of SYBR from phage lambda DNA2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID685501HARVARD: Inhibition of liver stage Plasmodium berghei infection in HepG2 cells2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID748999Inhibition of NDM-1 (unknown origin) using nitrocefin as substrate preincubated 10 mins followed by substrate addition measured after 20 mins relative to control2013Bioorganic & medicinal chemistry, Jun-01, Volume: 21, Issue:11
An altered zinc-binding site confers resistance to a covalent inactivator of New Delhi metallo-beta-lactamase-1 (NDM-1) discovered by high-throughput screening.
AID731872Cellular uptake in mouse DA-3 cell nucleus at 10 uM after 30 mins by DRAQ5 deep red staining-based confocal microscopic analysis relative to control2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID524794Antiplasmodial activity against Plasmodium falciparum GB4 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID562242Antimycobacterial activity against Mycobacterium smegmatis grown in nitrogen -limited broth medium assessed as growth inhibition in mid-logarithmic phase by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID685502HARVARD: Inhibition of blood stage Plasmodium falciparum 3D7 infection2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID749000Inhibition of NDM-1 (unknown origin) using nitrocefin as substrate preincubated 10 mins followed by substrate addition measured after 20 mins2013Bioorganic & medicinal chemistry, Jun-01, Volume: 21, Issue:11
An altered zinc-binding site confers resistance to a covalent inactivator of New Delhi metallo-beta-lactamase-1 (NDM-1) discovered by high-throughput screening.
AID731873Ratio of idarubicin IC50 to compound IC50 for displacement of YOYO1 from phage lambda DNA2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID477295Octanol-water partition coefficient, log P of the compound2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
QSPR modeling of octanol/water partition coefficient of antineoplastic agents by balance of correlations.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID524790Antiplasmodial activity against Plasmodium falciparum 3D7 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID731883Cytotoxicity against mouse DA-3 cells after 24 hrs by XTT assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID731870Cellular uptake in mouse DA-3 cell lysosome at 10 uM after 30 mins by LysoTracker green staining-based confocal microscopic analysis relative to control2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID748997Inhibition of TEM-1 (unknown origin) using nitrocefin as substrate preincubated 10 mins followed by substrate addition measured after 20 mins relative to control2013Bioorganic & medicinal chemistry, Jun-01, Volume: 21, Issue:11
An altered zinc-binding site confers resistance to a covalent inactivator of New Delhi metallo-beta-lactamase-1 (NDM-1) discovered by high-throughput screening.
AID524792Antiplasmodial activity against Plasmodium falciparum D10 after 72 hrs by SYBR green assay2009Nature chemical biology, Oct, Volume: 5, Issue:10
Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID685500HARVARD: Cytotoxicity in HepG2 cell line2012Proceedings of the National Academy of Sciences of the United States of America, May-29, Volume: 109, Issue:22
Liver-stage malaria parasites vulnerable to diverse chemical scaffolds.
AID748998Inhibition of TEM-1 (unknown origin) using nitrocefin as substrate preincubated 10 mins followed by substrate addition measured after 20 mins2013Bioorganic & medicinal chemistry, Jun-01, Volume: 21, Issue:11
An altered zinc-binding site confers resistance to a covalent inactivator of New Delhi metallo-beta-lactamase-1 (NDM-1) discovered by high-throughput screening.
AID731871Cellular uptake in mouse DA-3 cell mitochondria at 10 uM after 30 mins by mitotracker red staining-based confocal microscopic analysis2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID1755099Cytotoxicity against human BJ cells assessed as reduction in cell viability at 58 uM2021Bioorganic & medicinal chemistry letters, 09-01, Volume: 47Antimalarial activity of 2,6-dibenzylidenecyclohexanone derivatives.
AID731875Ratio of doxorubicin IC50 to compound IC50 for displacement of SYBR from phage lambda DNA2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID562240Antimycobacterial activity against Mycobacterium smegmatis grown in Luria-Bertani broth medium assessed as growth inhibition in mid-logarithmic phase by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Modifying culture conditions in chemical library screening identifies alternative inhibitors of mycobacteria.
AID731884Cytotoxicity against human SKOV3 cells after 24 hrs by XTT assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID1676758Antiplasmodial activity against Plasmodium falciparum 3D7 infected in human erythrocytes assessed as growth inhibition at 58 uM after 72 hrs by SYBR Gren-I fluorescent dye based method2020Journal of medicinal chemistry, 10-22, Volume: 63, Issue:20
Synthesis and Structure-Activity Relationship of Dual-Stage Antimalarial Pyrazolo[3,4-
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID731876Displacement of SYBR from phage lambda DNA by FID assay2013ACS medicinal chemistry letters, Mar-14, Volume: 4, Issue:3
The structure of anthracycline derivatives determines their subcellular localization and cytotoxic activity.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1719374Cytotoxicity against human BJ cells assessed as reduction in cell viability at 58 uM by relative to control2021Bioorganic & medicinal chemistry letters, 03-01, Volume: 35Identification of Plasmodium falciparum heat shock 90 inhibitors via molecular docking.
AID1171738Antiproliferative activity against human K562 cells after 72 hrs2014Journal of natural products, Dec-26, Volume: 77, Issue:12
Injury-induced biosynthesis of methyl-branched polyene pigments in a white-rotting basidiomycete.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID312292Cytotoxicity against human K562 cells after 5 days by XTT assay2007Journal of natural products, Dec, Volume: 70, Issue:12
Curcumin induces high levels of topoisomerase I- and II-DNA complexes in K562 leukemia cells.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1347414qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Secondary screen by immunofluorescence2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,686)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990155 (9.19)18.7374
1990's437 (25.92)18.2507
2000's546 (32.38)29.6817
2010's438 (25.98)24.3611
2020's110 (6.52)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 50.53

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index50.53 (24.57)
Research Supply Index7.72 (2.92)
Research Growth Index4.84 (4.65)
Search Engine Demand Index84.88 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (50.53)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials454 (25.29%)5.53%
Reviews139 (7.74%)6.00%
Case Studies321 (17.88%)4.05%
Observational3 (0.17%)0.25%
Other878 (48.91%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (221)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique. [NCT03727633]Phase 253 participants (Anticipated)Interventional2018-07-19Recruiting
S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Poor-Risk Acute Myelogenous Leukemia [NCT00840177]Phase 2115 participants (Actual)Interventional2009-12-10Completed
Phase I Study of Lenalidomide and Conventional Chemotherapy in Acute Myeloid Leukemia [NCT01132586]Phase 161 participants (Actual)Interventional2010-05-31Completed
A Prospective Randomized Comparison of Idarubicin and High-dose Daunorubicin in Combination With Cytarabine in the Induction Chemotherapy for Acute Myeloid Leukemia [NCT01145846]Phase 3316 participants (Anticipated)Interventional2010-05-31Recruiting
Randomized Phase-II Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine [NCT01180322]Phase 2277 participants (Actual)Interventional2010-11-30Completed
A Phase 1b Study of JNJ-75276617 in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations [NCT05453903]Phase 1150 participants (Anticipated)Interventional2022-10-04Recruiting
CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study [NCT04375631]Phase 1120 participants (Anticipated)Interventional2020-12-03Recruiting
A Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Patients [NCT04112589]Phase 1/Phase 263 participants (Actual)Interventional2019-12-26Active, not recruiting
A Phase I and Expansion Cohort Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT03194932]Phase 162 participants (Actual)Interventional2017-07-11Completed
A Phase II Randomized Study to Assess the Efficacy on Outcome of Venetoclax Combined With Cytarabine Versus Idarubicin Combined With Cytarabine Administered as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission [NCT04968015]Phase 2134 participants (Anticipated)Interventional2022-05-25Recruiting
A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes [NCT01305135]Phase 1/Phase 241 participants (Actual)Interventional2010-12-30Completed
Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK [IMGN632]) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms [NCT06034470]Phase 130 participants (Anticipated)Interventional2024-01-13Recruiting
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Total Therapy for Adult T-lymphoblastic Lymphoma/Leukemia [NCT03564704]Phase 2/Phase 380 participants (Anticipated)Interventional2016-02-14Recruiting
Phase 1b, Open-label, Dose Escalation Study of Quizartinib in Combination With Induction and Consolidation Chemotherapy in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT02834390]Phase 17 participants (Actual)Interventional2016-08-12Completed
An Open-Label, One-Arm, Multi-Site Trial of Precision Diagnosis Directing Histone Deacetylase Inhibitor Chidamide Target Total Therapy for Adult Early T-cell Progenitor Acute Lymphoblastic Leukemia/Lymphoma [NCT03553238]Phase 2/Phase 370 participants (Anticipated)Interventional2016-02-14Recruiting
A Phase I Study of Volasertib Combined With Standard Induction Chemotherapy for Previously Untreated Patients With Acute Myeloid Leukemia (VIAC) [NCT02527174]Phase 10 participants (Actual)Interventional2016-11-30Withdrawn(stopped due to Volasertib no longer available)
Multicenter Randomised Clinical Trial in Acute Myeloid Leukemia Treatment Based on Three Anthracyclines, Comparing Two Types of Consolidation With Different ARA-C Doses Followed by One Year Maintenance [NCT01587430]Phase 4245 participants (Anticipated)Interventional2010-01-31Active, not recruiting
PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS [NCT01296178]200 participants (Anticipated)Interventional2010-12-31Recruiting
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial [NCT05586074]Phase 3324 participants (Anticipated)Interventional2023-03-03Recruiting
A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid [NCT02339740]Phase 3158 participants (Actual)Interventional2015-07-21Active, not recruiting
A Safety and Tolerability Trial of Crenolanib and Chemotherapy With Cytarabine and Anthracyclines in Patients With Newly Diagnosed Acute Myeloid Leukemia With FLT3 Activating Mutations [NCT02283177]Phase 244 participants (Actual)Interventional2015-01-31Completed
Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycop [NCT02416388]Phase 2/Phase 33,100 participants (Anticipated)Interventional2015-01-31Recruiting
Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults [NCT03390387]4,000 participants (Anticipated)Interventional2015-11-30Recruiting
A 2:1 Randomized Phase II Trial to Compare the Efficacy and Safety of Standard Chemotherapy Plus Quizartinib Versus Standard Chemotherapy Plus Placebo in Adult Patients With Newly Diagnosed FLT3 Wild-type AML [NCT04107727]Phase 2273 participants (Actual)Interventional2019-09-05Active, not recruiting
A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutate [NCT03591510]Phase 223 participants (Anticipated)Interventional2019-03-13Recruiting
An Investigator Sponsored Phase I Trial of Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML [NCT03661515]Phase 116 participants (Actual)Interventional2018-07-17Completed
Prospective Evaluation of Sorafenib Combined With Standard Therapy in Newly Diagnosed Adult Core-binding Factor Acute Myeloid Leukemia: an Open-label , Randomised Controlled, Multicenter Phase II Trial [NCT05404516]Phase 288 participants (Anticipated)Interventional2020-01-01Recruiting
"Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine Versus Conventional 7+3 Induction Chemotherapy of Acute Myeloid Leukemia in Young Adults" [NCT05177731]Phase 3188 participants (Anticipated)Interventional2022-03-01Recruiting
A Phase I Study of MEK Inhibitor MEK162 Combined With Idarubicin and Cytarabine Induction in Patients With Relapsed/Refractory RAS-Mutated Acute Myeloid Leukemia [NCT02049801]Phase 11 participants (Actual)Interventional2014-12-31Terminated(stopped due to logistics)
Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML) [NCT02013648]Phase 3203 participants (Anticipated)Interventional2014-07-31Active, not recruiting
Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT00422591]Phase 2175 participants (Actual)Interventional2006-12-31Completed
Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II [NCT02185768]Phase 246 participants (Actual)Interventional2015-01-31Completed
A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia [NCT01035502]Phase 251 participants (Actual)Interventional2009-12-31Completed
A Randomised Phase-III Trial of the Cooperative Weichteilsarkom Study Group (CWS) for Localised High-risk Rhabdomyosarcoma and Localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in Children, Adolescents, and Young Adults [NCT00876031]Phase 3195 participants (Actual)Interventional2009-07-01Completed
PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years) [NCT01366898]Phase 4100 participants (Anticipated)Interventional2007-06-30Recruiting
Transarterial Chemoembolization With Lipiodol-Idarubicin Emulsion in the Treatment of Hepatocellular Carcinoma: a Prospective, Multicenter, Real-world Study [NCT05280444]Phase 2/Phase 3216 participants (Anticipated)Interventional2022-05-28Recruiting
A Phase I/II Multi-center Study of HDM201 Added to Chemotherapy in Adult Subjects With Relapsed/Refractory (R/R) or Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT03760445]Phase 1/Phase 20 participants (Actual)Interventional2019-11-15Withdrawn(stopped due to It was determined that the study design may not be optimal given the changing AML treatment landscape.)
Randomized Phase II Trial Seeking the Most Promising Drug Association With Azacitidine- in Higher Risk Myelodysplastic Syndromes [NCT01342692]Phase 2320 participants (Anticipated)Interventional2011-06-30Active, not recruiting
Phase II Study of Idarubicin, Cytarabine, and Vorinostat in Patients With High-Risk MDS and AML [NCT00656617]Phase 2106 participants (Actual)Interventional2008-04-30Completed
A Phase IV, Randomized Study to Evaluate the Safety and Efficacy of Idarubicin at Different Dosages Combined With Cytarabine as Induction Therapy for Newly Diagnosed Acute Myeloid Leukaemia [NCT02277847]Phase 4400 participants (Anticipated)Interventional2010-03-31Enrolling by invitation
A PALG Prospective Multicenter Clinical Trial to Compare the Efficacy of Two Standard Induction Therapies (DA-90 vs DAC) and Two Standard Salvage Regimens (FLAG-IDA vs CLAG-M) in AML Patients ≤ 60 Years Old [NCT03257241]Phase 3582 participants (Anticipated)Interventional2017-07-03Recruiting
A Randomised Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA Versus Standard ATRA and Anthracycline-Based Chemotherapy (AIDA Regimen) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia [NCT00482833]Phase 3276 participants (Actual)Interventional2007-08-31Completed
Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML [NCT02115295]Phase 2458 participants (Anticipated)Interventional2014-05-19Recruiting
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients Wit [NCT04778397]Phase 3346 participants (Anticipated)Interventional2021-07-01Active, not recruiting
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia [NCT05955261]Phase 270 participants (Anticipated)Interventional2023-07-25Recruiting
A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia [NCT02873338]Phase 275 participants (Actual)Interventional2016-08-31Completed
Aezea (Cenersen) in Combination With Chemotherapy for Treatment of Acute Myelogenous Leukemia Subjects ≥55 Years of Age With No Response to Single Frontline Induction Course in a Randomized Double-Blind Placebo-Controlled Multi-Center Study [NCT00967512]Phase 20 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to Study Was Terminated due to lack of Funding.)
A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma [NCT02703272]Phase 372 participants (Actual)Interventional2016-07-01Terminated(stopped due to IDMC recommended that enrolment be stoped, as the EFS hazard ratio and associated p-value crossed the futility boundary specified in protocol (July 2020).)
A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over [NCT00005823]Phase 32,000 participants (Anticipated)Interventional1998-12-31Completed
A Phase I Dose Escalation Study of Ibrutinib With Idarubicin/Cytarabine for Relapsed/Refractory Acute Myeloid Leukemia [NCT02635074]Phase 12 participants (Actual)Interventional2016-11-30Terminated(stopped due to safety)
ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL) [NCT00967057]Phase 3470 participants (Anticipated)Interventional2002-10-31Completed
A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283]Phase 17 participants (Actual)Interventional2016-01-13Completed
A Pilot, Pharmacodynamic Correlate Trial of Sirolimus in Combination With Chemotherapy (Idarubicin, Cytarabine) for the Treatment of Newly Diagnosed Acute Myelogenous Leukemia [NCT01822015]Early Phase 155 participants (Actual)Interventional2013-03-15Completed
An Open-Label Phase 2 Trial of LY2181308 Sodium Administered in Combination With Idarubicin and Cytarabine to Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT00620321]Phase 224 participants (Actual)Interventional2008-03-31Completed
A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome [NCT06050941]Phase 260 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation [NCT02421939]Phase 3371 participants (Actual)Interventional2015-10-20Active, not recruiting
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial [NCT01040559]Phase 118 participants (Anticipated)Interventional2009-12-31Completed
Clofarabine in Combination With a Standard Remission Induction Regimen (AraC and Idarubicin) in Patients 18-60 Years Old With Previously Untreated Intermediate and Bad Risk Acute Myelogenous Leukemia (AML) or High Risk Myelodysplasia (MDS) : a Phase I-II [NCT00838240]Phase 1/Phase 2114 participants (Anticipated)Interventional2008-11-30Recruiting
Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation [NCT00866918]Phase 3106 participants (Actual)Interventional2009-03-09Completed
Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone [NCT04216771]Phase 2/Phase 3320 participants (Anticipated)Interventional2020-01-31Recruiting
Dasatinib in Combination With Chemotherapy for Relapsed or Refractory Core Binding Factor Acute Myeloid Leukemia: A Phase I Study (AflacLL1401) [NCT02680951]Phase 10 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Withdrawn due to lack of participants.)
A Phase 1b, Open-label Study of LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia [NCT02652871]Phase 136 participants (Anticipated)Interventional2016-05-09Completed
Dose-intense Idarubicin Induction in Young Patients With Acute Myeloid Leukemia [NCT04069208]Phase 242 participants (Anticipated)Interventional2019-09-03Recruiting
A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients [NCT03226418]Phase 275 participants (Actual)Interventional2017-07-07Active, not recruiting
Phase II Clinical Evaluation of Vorinostat Combined With Salvage Reinduction Chemotherapy Including Gemtuzumab Ozogamicin, Idarubicin and Cytarabine and Vorinostat Maintenance in Relapse or Refractory Acute Myeloid Leukemia Patients With 50 Years or Older [NCT01039363]Phase 227 participants (Anticipated)InterventionalNot yet recruiting
Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML) [NCT01025154]Phase 263 participants (Actual)Interventional2010-01-31Completed
Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation [NCT02671708]Phase 2/Phase 3153 participants (Actual)Interventional2016-01-31Completed
"A Phase I Trial of Volasertib (BI 6727), an Intravenous Polo-Like Kinase Inhibitor, in Combination With 7+3 Induction Chemotherapy for Patients With Acute Myeloid Leukemia" [NCT02905994]Phase 10 participants (Actual)Interventional2016-09-30Withdrawn(stopped due to Funding Withdrawn)
A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia [NCT00666588]Phase 252 participants (Actual)Interventional2008-04-30Completed
A Phase 1 Trial of Indoximod in Combination With Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT02835729]Phase 154 participants (Actual)Interventional2016-07-31Completed
An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia [NCT01873807]Phase 4100 participants (Anticipated)Interventional2013-05-31Recruiting
Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT01831232]24 participants (Actual)Interventional2013-05-31Completed
Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis [NCT00006367]Phase 20 participants Interventional2000-05-31Completed
Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL) [NCT00016159]Phase 235 participants (Anticipated)Interventional2000-11-30Completed
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result [NCT00146120]Phase 3400 participants Interventional1998-05-31Completed
A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years [NCT04087967]Phase 3162 participants (Anticipated)Interventional2019-04-01Recruiting
Phase 1B/II Study of Escalating Doses of Pevonedistat (TAK-924, Formerly MLN4924) Administered in Combination With Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed High Risk Acute Myelogenous Leukemia (AML) [NCT03330821]Phase 1/Phase 253 participants (Anticipated)Interventional2018-04-18Active, not recruiting
A Pilot Study of Lestaurtinib (CEP-701) in Combination With Chemotherapy in Young Patients With Relapsed or Refractory FLT3-mutant Acute Myeloid Leukemia [NCT00469859]Phase 1/Phase 214 participants (Actual)Interventional2007-06-30Completed
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma [NCT00193973]Phase 220 participants (Actual)Interventional2001-07-31Completed
Idarubicin Overcomes Multidrug Resistant-1(MDR1) Induced Chemoresistance With Higher Induction Remission Rate and Remission Quality Than Daunorubicin in de Novo Acute Myeloid Leukemia Patients [NCT01889407]94 participants (Anticipated)Observational [Patient Registry]2013-08-31Recruiting
[NCT01958996]Phase 1/Phase 227 participants (Anticipated)Interventional2009-01-31Completed
Pilot Study of Crenolanib Combined With Standard Salvage Chmetherapy in Subjects With Relapsed/Refractory Acute Myeloid Leukemia [NCT02626338]Phase 1/Phase 216 participants (Actual)Interventional2016-02-29Completed
Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study [NCT01987297]Phase 4738 participants (Anticipated)Interventional2012-06-30Active, not recruiting
Philadelphia -Negative High-risk Children Acute Lymphoblastic Leukemia(ALL) Treatment:Induction Therapy:Vincristine(V),Idarubicin(I),L-asparaginase(L),Dexamethasone(D);Consolidation:V+Daunorubicin(D)+L+D, Methotrexate,Cytarabine [NCT01990807]Phase 420 participants (Anticipated)Interventional2012-10-31Recruiting
[NCT02020161]Phase 4200 participants (Anticipated)Interventional2012-06-30Recruiting
LIDA-B: Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study [NCT02028949]Phase 115 participants (Actual)Interventional2012-11-22Completed
A Phase I Study of Pomalidomide Given at the Time of Lymphocyte Recovery Following Induction Timed Sequential Chemotherapy With Cytarabine, Daunorubicin and Etoposide (AcDVP16) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and High-Risk MD [NCT02029950]Phase 150 participants (Actual)Interventional2013-12-16Completed
An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics [NCT05260528]Phase 2210 participants (Anticipated)Interventional2023-05-03Recruiting
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma [NCT00006232]Phase 3200 participants (Anticipated)Interventional1996-10-31Completed
A Phase II, Single Arm Study of Tislelizumab Combined With DNA Demethylation Agent +/- CAG Regimen in the Treatment of Patients With High-risk AML or AML Patients Older Than 60 Years of Age Who Are Unfit for Intensive Chemotherapy [NCT04541277]Phase 255 participants (Anticipated)Interventional2020-09-01Recruiting
A Phase II Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT03164057]Phase 2206 participants (Actual)Interventional2017-06-15Active, not recruiting
Four-Arm Randomized Phase II Study of SGI-110: 5 Days, Versus 10 Days, Versus 5 Days + Idarubicin, Versus 5 Days + Cladribine, in Previously Untreated Patients >/= 70 Years With Acute Myeloid Leukemia [NCT02096055]Phase 244 participants (Actual)Interventional2014-04-04Completed
A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy [NCT00878722]Phase 1/Phase 241 participants (Actual)Interventional2007-08-31Completed
Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia [NCT02848183]Phase 2350 participants Interventional2016-01-31Recruiting
Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study [NCT00006122]Phase 2106 participants (Actual)Interventional2000-06-30Completed
Randomized Phase II Trial of Idarubicin + Ara-C +/- Bevacizumab in Patients Age < 60 With Untreated Acute Myeloid Leukemia [NCT00096148]Phase 2120 participants (Actual)Interventional2004-10-31Terminated(stopped due to Administratively complete.)
AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL) [NCT00180128]Phase 480 participants (Anticipated)Interventional2000-01-31Recruiting
Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00187005]Phase 353 participants (Actual)Interventional1998-07-31Terminated(stopped due to Toxicity)
A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16) [NCT00187083]Phase 340 participants (Actual)Interventional1997-02-28Completed
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas [NCT00210366]Phase 225 participants (Anticipated)Interventional2004-11-30Terminated(stopped due to due to slow accrual)
Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT00151242]Phase 2/Phase 3920 participants (Actual)Interventional2004-07-31Completed
[NCT02937662]Phase 260 participants (Anticipated)Interventional2016-10-31Recruiting
Phase I/II Clinical Study of Idarubicin Dose Intensification for Remission Induction Therapy in Acute Myeloid Leukemia Patients Age of 65 Years or Less [NCT01518556]Phase 1/Phase 249 participants (Actual)Interventional2011-07-31Active, not recruiting
A Randomized Controlled, Multi-center Clinical Study of Anbijian (Idarubicin Hydrochloride for Injection) vs. Epirubicin Lipiodol Emulsion Transhepatic Arterial Chemoembolization in the Treatment of Hepatocellular Carcinoma [NCT05053386]186 participants (Anticipated)Interventional2021-10-31Not yet recruiting
A Study to Determine the Safety and Efficacy of Using CD8-High Density Microparticles (CD8-HDM) to Deplete CD8+ Cells From Donor Lymphocyte Infusion in Order to Reduce Graft-versus-Host Disease (GvHD) Without Compromising an Anti-Leukemia Effect in Patien [NCT00004878]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to study never opened)
PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years [NCT00464217]Phase 4100 participants Interventional1998-10-31Completed
Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia) [NCT01247493]Phase 2108 participants (Actual)Interventional2007-06-30Completed
FLAG-IDA Chemotherapy Induction Follow by Intensive Chemotherapy Postremission +/- Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemi [NCT00487448]Phase 4200 participants (Anticipated)Interventional1998-07-31Completed
A Phase 1/2 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT02310321]Phase 1/Phase 284 participants (Actual)Interventional2015-02-26Active, not recruiting
Phase I Dose Escalating Trial of VELCADE (PS-341) in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia [NCT00505700]Phase 136 participants (Anticipated)Interventional2003-07-31Completed
A Phase 1 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT02236013]Phase 180 participants (Actual)Interventional2015-01-07Completed
A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia [NCT02306291]Phase 1/Phase 291 participants (Actual)Interventional2015-03-31Completed
A Phase 2 Randomized Study Comparing Venetoclax and Azacitidine to Induction Chemotherapy for Newly Diagnosed Fit Adults With Acute Myeloid Leukemia [NCT04801797]Phase 2172 participants (Anticipated)Interventional2021-05-20Recruiting
TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL [NCT00002532]Phase 20 participants Interventional1993-01-31Active, not recruiting
ACUTE MYELOID LEUKAEMIA TRIAL 12 [NCT00002658]Phase 32,000 participants (Anticipated)Interventional1994-01-31Active, not recruiting
A Phase 1, Multicenter, Open-Label, Safety Study of AG-120 or AG-221 in Combination With Induction Therapy and Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia With an IDH1 and/or IDH2 Mutation [NCT02632708]Phase 1153 participants (Actual)Interventional2015-12-31Active, not recruiting
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia [NCT01484171]Phase 350 participants (Anticipated)Interventional2011-08-31Recruiting
A Phase I Trial Evaluating the Effect of the Addition of HMGCoA-Reductase Inhibition With Pravastatin to Salvage Chemotherapy Idarubicin-HDAC in Patients With Relapsed or Refractory Acute Myelogenous Leukemia [NCT00107523]Phase 10 participants Interventional2005-01-31Completed
Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents [NCT00111345]Phase 2/Phase 3550 participants (Actual)Interventional2004-03-31Active, not recruiting
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia [NCT06001788]Phase 1171 participants (Anticipated)Interventional2023-12-31Recruiting
Arsenic Trioxide, High-Dose Cytarabine and Idarubicin Induction Therapy in Previously Untreated de Novo and Secondary Adult Acute Myeloid Leukemia Patients < 60 Years Old - A Phase I Study [NCT00093483]Phase 161 participants (Actual)Interventional2002-04-30Completed
A Phase 1 Study of Suberoylanilide Hydroxamic Acid (Vorinostat, SAHA) in Combination With Idarubicin in Relapsed or Refractory Leukemia [NCT00331513]Phase 140 participants (Actual)Interventional2006-03-31Completed
IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY [NCT00002517]Phase 30 participants Interventional1993-03-31Completed
A Phase I Study Investigating the Combination of RAD001 With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT01154439]Phase 111 participants (Actual)Interventional2010-10-31Completed
A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia [NCT00801489]Phase 2270 participants (Anticipated)Interventional2007-04-04Recruiting
Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin [NCT00413166]Phase 278 participants (Actual)Interventional2006-12-31Completed
Phase II Study of Combined All-Trans Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy [NCT00528450]Phase 21 participants (Actual)Interventional2007-09-30Terminated(stopped due to Lack of accrual)
A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia [NCT02135874]Phase 218 participants (Actual)Interventional2014-10-27Completed
A Phase 1b Study With Expansion Cohort of Escalating Doses of KRT-232 (AMG 232) Administered in Combination With Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed Acute Myelogenous Leukemia (AML) [NCT04190550]Phase 124 participants (Anticipated)Interventional2021-02-04Active, not recruiting
Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX) [NCT06114082]Phase 2128 participants (Anticipated)Interventional2023-04-28Recruiting
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003) [NCT00198991]Phase 41,883 participants (Actual)Interventional2003-04-30Completed
Phase I/II Study on Cytarabine and Idarubicin Combined With Escalating Doses of Clofarabine as Induction Therapy in Patients With Acute Myeloid Leukemia and High Risk for Induction Failure (AMLSG 17-10) [NCT01534702]Phase 1/Phase 260 participants (Anticipated)Interventional2012-01-31Recruiting
[NCT01540812]418 participants (Actual)Observational2012-02-29Completed
A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase [NCT00023920]Phase 260 participants (Actual)Interventional2001-07-31Terminated(stopped due to Administratively complete.)
Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase [NCT00025402]Phase 31,000 participants (Anticipated)Interventional1997-07-31Active, not recruiting
Open Label, Phase II Dosing Study of Ara-C Chemotherapy in Combination With EL625 and Idarubicin in Refractory and Relapsed Acute Myelogenous Leukemia (AML) [NCT00074737]Phase 253 participants (Actual)Interventional2004-04-30Completed
Idarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin (IAGO) for Young Untreated Patients, Without an HLA Identical Sibling, With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration: A Phase II Study [NCT00077116]Phase 231 participants (Actual)Interventional2003-11-30Completed
Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms [NCT03589729]Phase 2100 participants (Anticipated)Interventional2018-09-19Recruiting
Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC [NCT00052299]Phase 3472 participants (Actual)Interventional2002-09-30Completed
Protocol for the Treatment of Adults Aged NCT00209833]Phase 2/Phase 3200 participants Interventional1999-01-31Active, not recruiting
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma [NCT00124813]Phase 280 participants (Anticipated)Interventional2002-08-31Recruiting
Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT00151255]Phase 3500 participants (Anticipated)Interventional2004-06-30Completed
Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem C [NCT00199147]Phase 4250 participants Interventional2000-01-31Recruiting
A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia ( [NCT00199186]Phase 20 participants Interventional2002-03-31Recruiting
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006), an Oral Vascular Endothelial Growth Factor (VEGF), Rapidly Accelerated Fibrosarcoma (RAF) and FMS-like Tyrosine Kinase 3 (FLT3), in Patients With High-risk MDS and AML [NCT00542971]Phase 1/Phase 278 participants (Actual)Interventional2007-10-31Completed
The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China [NCT03173612]132 participants (Anticipated)Interventional2016-08-31Recruiting
A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)) [NCT04047641]Phase 1/Phase 280 participants (Anticipated)Interventional2019-10-22Recruiting
A Randomized Phase II Study of Nuclear Factor-kappa B (NF-κB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia [NCT02144675]Phase 227 participants (Actual)Interventional2009-01-31Completed
Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia [NCT01794702]Phase 1/Phase 265 participants (Actual)Interventional2013-02-20Completed
A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Mye [NCT02668653]Phase 3539 participants (Actual)Interventional2016-09-01Completed
Phase II Trial Examining Epigenetic Priming With Decitabine Followed by Idarubicin and Cytarabine for Patients With Relapsed or Refractory AML. [NCT01607645]Phase 27 participants (Actual)Interventional2012-07-31Terminated(stopped due to The study was terminated early because there were other competing protocols.)
Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy. [NCT01700413]Phase 248 participants (Actual)Interventional2012-10-31Completed
A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation [NCT01773408]Phase 1122 participants (Actual)Interventional2013-02-28Completed
A Phase I Study of the Aurora A Kinase Inhibitor Alisertib in Combination With 7+3 Induction Chemotherapy in Patients With Acute Myeloid Leukemia [NCT01779843]Phase 122 participants (Actual)Interventional2013-04-30Completed
"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565]Phase 361 participants (Actual)Interventional1994-05-25Completed
Risk-adapted Therapy for Primary Acute Myeloid Leukemia (AML) in Adult Patients up to 70 Years Old [NCT04687098]Phase 21,034 participants (Actual)Interventional2012-02-01Completed
Multicenter, Prospective, Open-label, Single-arm, Phase I-II Clinical Trial to Analyze Induction Therapy With a Combination of Fludarabine, Idarubicin, Cytarabine, G-CSF and Plerixafor for the Treatment of Young Patients With Relapsed or Refractory AML [NCT01435343]Phase 1/Phase 255 participants (Actual)Interventional2012-07-31Completed
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children: A Prospective Multicenter Study in South China [NCT05313958]Phase 2/Phase 343 participants (Anticipated)Interventional2021-12-01Recruiting
Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia [NCT05053425]30 participants (Anticipated)Interventional2021-10-20Recruiting
A Randomized Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA and Idarubicin Versus Standard ATRA and Anthracyclines-based Chemotherapy (AIDA Regimen) for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia [NCT02688140]Phase 3280 participants (Anticipated)Interventional2016-06-30Active, not recruiting
A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia [NCT00382954]Phase 155 participants (Anticipated)Interventional2004-02-29Completed
Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Sec [NCT00002926]Phase 380 participants (Anticipated)Interventional1996-12-31Active, not recruiting
A Prospective Randomized Phase I/II Study of Clofarabine (Clo) and Ara-C vs Clo and Ida vs Clo Plus Ida and Ara-C in Patients With First Relapse or First Salvage of Primary Refractory AML; and High-Grade MDS(>/= 10% Blasts); or CML in Myeloid Blasts Phase [NCT00067028]Phase 2116 participants (Actual)Interventional2003-12-31Completed
PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL [NCT00002800]Phase 260 participants (Anticipated)Interventional1996-07-31Completed
Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study [NCT00002812]Phase 32,078 participants (Actual)Interventional1996-09-30Completed
Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study [NCT00003178]Phase 2120 participants (Actual)Interventional1998-03-31Completed
A Phase I Study of Cytosine Arabinoside, Idarubicin, and Amifostine as Induction Therapy for Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT00003268]Phase 10 participants Interventional1998-01-31Completed
PHASE I-II STUDY OF IDARUBICIN, CYTARABINE AND R115777 (TIPIFARNIB, ZARNESTRA; 702818; IND 58359), A FARNESYLTRANSFERASE INHIBITOR, IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROMES AND ACUTE MYELOID LEUKEMIAS [NCT00096122]Phase 1/Phase 295 participants (Actual)Interventional2004-09-30Completed
Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia [NCT00199095]Phase 440 participants Interventional1997-02-28Completed
Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99) [NCT00199056]Phase 4225 participants Interventional1999-10-31Completed
Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2) [NCT00198978]Phase 4377 participants (Actual)Interventional2003-01-31Completed
Safety and Clinical Activity of Treanda® (Bendamustine HCL) and Idarubicin in Combination Therapy for Patients Age >= 50 With Previously Untreated Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome [NCT01141725]Phase 1/Phase 239 participants (Actual)Interventional2010-09-30Completed
Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome [NCT01289457]Phase 1/Phase 2282 participants (Actual)Interventional2011-02-02Completed
A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes [NCT01692197]Phase 243 participants (Actual)Interventional2013-02-01Completed
A Phase II Study of the Aurora A Kinase Inhibitor Alisertib in Combination With 7+3 Induction Chemotherapy in Patients With High-risk Acute Myeloid Leukemia [NCT02560025]Phase 242 participants (Actual)Interventional2015-12-31Completed
Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children [NCT00003729]Phase 213 participants (Actual)Interventional1998-12-31Terminated(stopped due to low accrual)
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence [NCT00317408]96 participants (Anticipated)Interventional2004-04-30Active, not recruiting
A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) [NCT00002798]Phase 3880 participants (Actual)Interventional1996-08-31Completed
EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE III GROUP-WIDE STUDY [NCT00002816]Phase 3120 participants (Anticipated)Interventional1996-12-31Completed
INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LE [NCT00002701]Phase 3750 participants (Anticipated)Interventional1995-10-31Active, not recruiting
RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL) [NCT00002719]Phase 3500 participants (Anticipated)Interventional1995-12-31Completed
A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission [NCT00003602]Phase 3400 participants (Anticipated)Interventional1998-03-31Active, not recruiting
CAMP-010: PHASE I/II STUDY OF IN VIVO PURGING FOLLOWED BY HIGH DOSE CHEMOTHERAPY, AUTOLOGOUS HEMATOPOIETIC STEM CELL INFUSION AND IMMUNOTHERAPY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA [NCT00002761]Phase 1/Phase 20 participants (Actual)Interventional1996-02-29Withdrawn(stopped due to PI left institution)
Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG [NCT00003758]Phase 260 participants (Anticipated)Interventional1998-12-31Active, not recruiting
A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse [NCT00002989]Phase 3207 participants (Anticipated)Interventional1997-03-31Active, not recruiting
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
RANDOMIZED PHASE III STUDY OF INDUCTION (ICE VS MICE VS DCE) AND INTENSIVE CONSOLIDATION (IDIA VS NOVIA VS DIA) FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA: AML 10 PROTOCOL [NCT00002549]Phase 31,520 participants (Anticipated)Interventional1993-11-30Active, not recruiting
PHASE II TRIAL OF POST-REMISSION THERAPY WITH HuM195 AND CYTOTOXIC CHEMOTHERAPY FOR ACUTE PROMYELOCYTIC LEUKEMIA [NCT00002609]Phase 240 participants (Actual)Interventional1994-08-31Completed
PROSPECTIVE CONTROLLED STUDY FOR THE OPTIMIZATION OF THERAPY IN CHRONIC MYELOID LEUKEMIA (CML): MULTICENTRIC STUDY FOR THE EVALUATION OF INTERFERON ALPHA VS ALLOGENIC BM TRANSPLANTATION WITH CHEMOTHERAPY IN CML [NCT00002771]Phase 3750 participants (Anticipated)Interventional1995-01-31Active, not recruiting
High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia [NCT00002945]Phase 361 participants (Actual)Interventional1996-12-31Completed
Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants: Induction Using High-Dose Cytarabine, Mitoxantrone and Ethyol; Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha [NCT00003405]Phase 20 participants (Actual)Interventional1998-04-30Withdrawn(stopped due to No enrollment)
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma [NCT00003603]Phase 3660 participants (Anticipated)Interventional1998-03-31Active, not recruiting
Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia [NCT00004905]Phase 20 participants Interventional1999-10-31Completed
Randomised Controlled Trial of CID (Chlorambucil, Idarubicin, Dexamethasone) Versus CD (Chlorambucil, Dexamethasone) for Induction of Remission in Low Grade Non-Hodgkin's Lymphoma (Kiel Classification) Followed by Randomised Controlled Assessment of Stand [NCT00003639]Phase 3200 participants (Anticipated)Interventional1993-11-30Active, not recruiting
ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study [NCT00003783]Phase 236 participants (Actual)Interventional1999-03-31Completed
A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t). [NCT00363025]Phase 3465 participants Interventional1999-11-30Terminated
Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) [NCT02464657]Phase 1/Phase 244 participants (Actual)Interventional2015-07-31Completed
Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, [NCT03926624]Phase 3450 participants (Anticipated)Interventional2019-11-22Recruiting
Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients NCT00534469]Phase 260 participants (Actual)Interventional2000-02-08Active, not recruiting
Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Ne [NCT02881086]Phase 31,000 participants (Actual)Interventional2016-08-31Active, not recruiting
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021) [NCT05518383]Phase 4300 participants (Anticipated)Interventional2022-05-25Recruiting
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations [NCT02400281]Phase 1/Phase 228 participants (Actual)Interventional2015-09-30Completed
Allogeneic Hematopoietic Stem Cell Transplantation as Initial Salvage Therapy for Patients With Primary Induction Failure Acute Myeloid Leukemia Refractory to High-Dose Cytarabine-Based Induction Chemotherapy [NCT02441803]Phase 211 participants (Actual)Interventional2015-09-14Active, not recruiting
PROSPECTIVE RANDOMISED STUDY TO COMPARE INTERFERON-ALPHA-n1 (WELLFERON) VS 'IDAC' CHEMOTHERAPY AND AUTOGRAFTING FOLLOWED BY INTERFERON ALPHA-n1 (WELLFERON) IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA [NCT00002868]Phase 3744 participants (Anticipated)Interventional1997-11-20Completed
Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML) [NCT00528398]Phase 2111 participants (Actual)Interventional1994-09-30Completed
An Investigator-Initiated Study To Evaluate Ara-C and Idarubicin in Combination With the Selective Inhibitor Of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Relapsed Or Refractory AML [NCT02249091]Phase 242 participants (Actual)Interventional2014-09-30Completed
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblast [NCT03860844]Phase 267 participants (Actual)Interventional2019-08-06Terminated(stopped due to Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.)
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring. [NCT00458848]Phase 2470 participants (Actual)Interventional2004-10-31Completed
BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1 (BLAST MRD AML-1): A Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination With Conventional Intensive Chemotherapy as F [NCT04214249]Phase 2124 participants (Anticipated)Interventional2021-02-17Recruiting
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma [NCT03117751]Phase 2/Phase 3790 participants (Actual)Interventional2017-03-29Active, not recruiting
A Phase 1/2 Study of Sequential Idarubicin + Cytarabine, Followed by Lenalidomide, in Patients With Myelodysplastic Syndrome (RAEB-2) or With Previously Untreated Acute Myeloid Leukemia [NCT00831766]Phase 1/Phase 251 participants (Actual)Interventional2009-06-25Completed
A Randomized Phase III Study of Standard Cytarabine Plus Daunorubicin (7+3) Therapy or Idarubicin With High Dose Cytarabine (IA) Versus IA With Vorinostat (NSC-701852) (IA + V) in Younger Patients With Previously Untreated Acute Myeloid Leukemia (AML) [NCT01802333]Phase 3754 participants (Actual)Interventional2013-02-12Completed
Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myelo [NCT03250338]Phase 3322 participants (Anticipated)Interventional2018-06-05Recruiting
AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard-of-Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients [NCT02440568]Phase 1/Phase 222 participants (Actual)Interventional2015-06-05Terminated
Epacadostat With Idarubicin and Cytarabine (EIC) for First-line Treatment of AML Patients Fit for Intensive Chemotherapy; a Phase I Study [NCT03444649]Phase 10 participants (Actual)Interventional2018-09-30Withdrawn(stopped due to IMP will not be further developed)
Retrospective Study on TACE for HCC by TANDEM and Idarubicin [NCT03349957]98 participants (Actual)Observational2017-12-01Completed
Safety and Efficacy of Chemotherapy Combined With Adoptive Transfer of Human Leukocyte Antigen (HLA)-Haploidentical Donor Lymphocyte Infusion (DLI) in Older Patients With Righ-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) [NCT02046122]Phase 1/Phase 219 participants (Actual)Interventional2014-07-31Completed
A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML [NCT03214562]Phase 1/Phase 2116 participants (Anticipated)Interventional2017-09-26Recruiting
Phase I/II Study of the Combination of Dasatinib With Chemotherapy for High Risk Acute Myeloid Leukemia (AML) Patients [NCT01876953]Phase 1/Phase 220 participants (Actual)Interventional2013-09-13Terminated(stopped due to Due to the budget issues, the study discontinued at Phase II.)
Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence [NCT04178642]Phase 20 participants (Actual)Interventional2020-09-22Withdrawn(stopped due to no participants enrolled)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00067028 (2) [back to overview]Overall Response Rate (ORR)
NCT00067028 (2) [back to overview]Participants With a Response
NCT00096122 (1) [back to overview]Number of Participants With Complete Response
NCT00413166 (1) [back to overview]Complete Response (CR) Rate
NCT00422591 (2) [back to overview]Overall Survival (OS)
NCT00422591 (2) [back to overview]Event-Free Survival (EFS)
NCT00458848 (3) [back to overview]Number of Patients Reaching Complete Hematological Response After Induction Therapy
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Disease Free Survival
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Overall Survival
NCT00469859 (2) [back to overview]>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points
NCT00469859 (2) [back to overview]Dose-limiting Toxicity
NCT00528450 (1) [back to overview]Molecular Remission Rate
NCT00534469 (2) [back to overview]Disease-Free Survival at 2-Year Post-Transplant
NCT00534469 (2) [back to overview]Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk
NCT00542971 (2) [back to overview]Maximum Tolerated Dose (MTD)
NCT00542971 (2) [back to overview]Number of Participants With Complete Response
NCT00620321 (6) [back to overview]Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates)
NCT00620321 (6) [back to overview]Change From Baseline in Survivin Index at Day 2
NCT00620321 (6) [back to overview]Area Under the Curve of LY2181308 Over the Dosing Interval
NCT00620321 (6) [back to overview]Number of Participants With Adverse Events (Safety Profile)
NCT00620321 (6) [back to overview]Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up
NCT00620321 (6) [back to overview]Pharmacodynamics: Number of Participants With Survivin Protein Expression
NCT00656617 (2) [back to overview]Progression Free Survival (PFS) at 7 Months
NCT00656617 (2) [back to overview]Participant Response
NCT00666588 (5) [back to overview]Proteasome Inhibition Activity
NCT00666588 (5) [back to overview]Dose Limiting Toxicity
NCT00666588 (5) [back to overview]Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1
NCT00666588 (5) [back to overview]Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion
NCT00666588 (5) [back to overview]NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)
NCT00831766 (5) [back to overview]Median Overall Survival (OS)
NCT00831766 (5) [back to overview]Rate of Lenalidomide Related Toxicity During Maintenance Therapy
NCT00831766 (5) [back to overview]Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)
NCT00831766 (5) [back to overview]Median Progression-Free Survival (PFS)
NCT00831766 (5) [back to overview]Phase I: Recommended Phase II Dose
NCT00840177 (4) [back to overview]Overall Survival (OS)
NCT00840177 (4) [back to overview]Relapse-free Survival (RFS)
NCT00840177 (4) [back to overview]Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0
NCT00840177 (4) [back to overview]Complete Remission (CR) Rate (Including CR With Incomplete Recovery)
NCT00866918 (4) [back to overview]Event-free Survival (EFS)
NCT00866918 (4) [back to overview]Hematologic Remission Rate
NCT00866918 (4) [back to overview]Overall Survival (OS)
NCT00866918 (4) [back to overview]Hematologic, Molecular, and Cytogenetic Remission Rate
NCT00878722 (11) [back to overview]Overall Survival
NCT00878722 (11) [back to overview]Relapse-Free Survival
NCT00878722 (11) [back to overview]Remission Duration
NCT00878722 (11) [back to overview]Time to Response (CR and PR)
NCT00878722 (11) [back to overview]Event-Free Survival
NCT00878722 (11) [back to overview]Elimination t½
NCT00878722 (11) [back to overview]Duration of Response (CR and PR)
NCT00878722 (11) [back to overview]Belinostat Cmax
NCT00878722 (11) [back to overview]Belinostat AUC (Area Under Curve)
NCT00878722 (11) [back to overview]Maximum Tolerated Dose, Dose Limiting Toxicity
NCT00878722 (11) [back to overview]Overall Response
NCT01025154 (2) [back to overview]Median Event-Free Survival (EFS)
NCT01025154 (2) [back to overview]Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
NCT01141725 (4) [back to overview]Disease-free Survival (DFS)
NCT01141725 (4) [back to overview]Maximum Tolerated Dose
NCT01141725 (4) [back to overview]Median Survival
NCT01141725 (4) [back to overview]Incidence of Greater Than or Equal to Grade 3 Toxicity
NCT01289457 (4) [back to overview]Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI)
NCT01289457 (4) [back to overview]Overall Survival
NCT01289457 (4) [back to overview]Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine
NCT01289457 (4) [back to overview]Event-Free Survival (EFS) at 2 Years
NCT01607645 (13) [back to overview]Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000
NCT01607645 (13) [back to overview]Duration of Severe Neutropenia Defined as an ANC Less Than 500
NCT01607645 (13) [back to overview]Duration of Moderate Neutropenia Defined as an ANC Less Than 1000
NCT01607645 (13) [back to overview]Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction
NCT01607645 (13) [back to overview]CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
NCT01607645 (13) [back to overview]CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
NCT01607645 (13) [back to overview]CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL
NCT01607645 (13) [back to overview]CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers
NCT01607645 (13) [back to overview]Number of Participants Who Achieved Morphologic CR
NCT01607645 (13) [back to overview]Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0
NCT01607645 (13) [back to overview]TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine
NCT01607645 (13) [back to overview]Severe Prolonged Aplasia
NCT01607645 (13) [back to overview]Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM
NCT01692197 (4) [back to overview]Disease-free Survival
NCT01692197 (4) [back to overview]Duration of Response
NCT01692197 (4) [back to overview]Overall Response
NCT01692197 (4) [back to overview]Overall Survival
NCT01794702 (4) [back to overview]To Determine the Disease-free Survival (DFS).
NCT01794702 (4) [back to overview]Overall Survival
NCT01794702 (4) [back to overview]Number of Participants With a Response
NCT01794702 (4) [back to overview]Maximum Tolerated Dose (MTD) of Clofarabine
NCT01802333 (10) [back to overview]EFS of Arm I Compared to Arm II
NCT01802333 (10) [back to overview]Event-free Survival (EFS)
NCT01802333 (10) [back to overview]Overall Survival (OS)
NCT01802333 (10) [back to overview]Prevalence of the Mutation NPM1 in Patients on This Study.
NCT01802333 (10) [back to overview]Rate of Allogeneic HCT
NCT01802333 (10) [back to overview]Cytogenetic Risk Distribution of Patients on This Study
NCT01802333 (10) [back to overview]Frequency and Severity of Toxicities
NCT01802333 (10) [back to overview]Complete Response (CR) Rate
NCT01802333 (10) [back to overview]Disease-free Survival (DFS)
NCT01802333 (10) [back to overview]Disease-free Survival (DFS) Among High Risk Patients
NCT01831232 (6) [back to overview]Progression Free Survival (PFS)
NCT01831232 (6) [back to overview]Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)
NCT01831232 (6) [back to overview]Number of Biomarker-positive Participants With Clinical Responses
NCT01831232 (6) [back to overview]Number of Participants With Good Complete Remission (CR)
NCT01831232 (6) [back to overview]Number of Participants With TRM.
NCT01831232 (6) [back to overview]Overall Survival
NCT01876953 (1) [back to overview]Maximum Tolerated Dose of Dasatinib (Phase I)
NCT02046122 (8) [back to overview]Percentage of Subjects With Unacceptable Toxicity
NCT02046122 (8) [back to overview]Number of Participants With Immune Recovery
NCT02046122 (8) [back to overview]Number of Days to Hematopoietic Recovery
NCT02046122 (8) [back to overview]Rate of Efficacy
NCT02046122 (8) [back to overview]Overall Survival
NCT02046122 (8) [back to overview]Number of Subjects With Unacceptable Toxicity
NCT02046122 (8) [back to overview]Disease Free Survival
NCT02046122 (8) [back to overview]Percentage of Subjects With Acute GVHD
NCT02096055 (5) [back to overview]Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.
NCT02096055 (5) [back to overview]Survival
NCT02096055 (5) [back to overview]Number of Participants With a Complete Response
NCT02096055 (5) [back to overview]Leukemia-free Survival
NCT02096055 (5) [back to overview]Remission Duration
NCT02144675 (1) [back to overview]Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients
NCT02249091 (8) [back to overview]Number of Participants With CR/CRi = Overall Reponse Rate
NCT02249091 (8) [back to overview]Event-Free Survival
NCT02249091 (8) [back to overview]Early Death Rate
NCT02249091 (8) [back to overview]Progression-Free Survival
NCT02249091 (8) [back to overview]Relapse-Free Survival
NCT02249091 (8) [back to overview]Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation)
NCT02249091 (8) [back to overview]Overall Survival
NCT02249091 (8) [back to overview]Number of Participants With Partial Remission (PR) = Rate of PR
NCT02339740 (2) [back to overview]EFS in High Risk APL Patients
NCT02339740 (2) [back to overview]Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients
NCT02421939 (12) [back to overview]Percentage of Participants Who Achieved Transfusion Conversion and Maintenance
NCT02421939 (12) [back to overview]Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)
NCT02421939 (12) [back to overview]Duration of Remission
NCT02421939 (12) [back to overview]Duration of Overall Survival (OS)
NCT02421939 (12) [back to overview]Duration of Leukemia-Free Survival (LFS)
NCT02421939 (12) [back to overview]Duration of Event-Free Survival (EFS)
NCT02421939 (12) [back to overview]Percentage of Participants With Composite Complete Remission (CRc Rate)
NCT02421939 (12) [back to overview]Change From Baseline in Brief Fatigue Inventory (BFI)
NCT02421939 (12) [back to overview]Number of Participants With Adverse Events
NCT02421939 (12) [back to overview]Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm
NCT02421939 (12) [back to overview]Percentage of Participants With Complete Remission (CR) Rate
NCT02421939 (12) [back to overview]Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant
NCT02440568 (6) [back to overview]Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading
NCT02440568 (6) [back to overview]Time to Hematologic Recovery
NCT02440568 (6) [back to overview]Progression Free Survival
NCT02440568 (6) [back to overview]Overall Participant Survival
NCT02440568 (6) [back to overview]Optimally Tolerated Dose
NCT02440568 (6) [back to overview]Event Free Survival
NCT02464657 (4) [back to overview]Overall Survival
NCT02464657 (4) [back to overview]Maximum Tolerated Dose (MTD) of Nivolumab
NCT02464657 (4) [back to overview]Event-Free Survival (EFS)
NCT02464657 (4) [back to overview]Relapse Free Survival
NCT02560025 (6) [back to overview]Number of Participants With Serious Adverse Events
NCT02560025 (6) [back to overview]Median Relapse Free Survival
NCT02560025 (6) [back to overview]1 Year Overall Survival Rate
NCT02560025 (6) [back to overview]Median Duration of Remission
NCT02560025 (6) [back to overview]Number of Participants That Achieved Complete Remission With Incomplete Blood Count Recovery (CRi)
NCT02560025 (6) [back to overview]Number of Participants That Achieved Complete Remission
NCT02626338 (1) [back to overview]Clinical Response to Crenolanib With Standard Salvage Chemotherapy
NCT02668653 (5) [back to overview]Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
NCT02668653 (5) [back to overview]Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
NCT02668653 (5) [back to overview]Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
NCT02668653 (5) [back to overview]Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
NCT02668653 (5) [back to overview]Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
NCT02703272 (37) [back to overview]Part 1 and Part 2: Gene Expression Evaluated by Disease-specific Biomarkers at Baseline
NCT02703272 (37) [back to overview]Part 2: Percentage of Participants Who Achieved Complete Response (CR)
NCT02703272 (37) [back to overview]Part 2: Overall Survival
NCT02703272 (37) [back to overview]Part 2: Number of Participants With c-MYC Gene Rearrangement
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation
NCT02703272 (37) [back to overview]Part 2: Duration of Response
NCT02703272 (37) [back to overview]Part 2: Tumor Volume Reduction Rate at Day 14
NCT02703272 (37) [back to overview]Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1 and Part 2: Visual Analog Scale (VAS) Score for Palatability
NCT02703272 (37) [back to overview]Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Time to Response
NCT02703272 (37) [back to overview]Part 2: Percentage of Participants With EFS at 3 Years
NCT02703272 (37) [back to overview]Part 2: Percentage of Participants With EFS at 2 Years
NCT02703272 (37) [back to overview]Part 1 and Part 2: Overall Response Rate (ORR)
NCT02703272 (37) [back to overview]Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1 and Part 2: Number of Participants With Greater Than (>) 90% Bruton's Tyrosine Kinase (BTK) Occupancy
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 1 and Part 2: Number of Participants With Adverse Events as Measure of Safety and Tolerability
NCT02703272 (37) [back to overview]Part 2: Percentage of Participants Who Achieved Partial Response (PR)
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Event Free Survival (EFS) Between the 2 Treatment Groups
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Number of Participants With CD79B, CARD11, and MYD Mutations
NCT02703272 (37) [back to overview]Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
NCT02703272 (37) [back to overview]Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia
NCT02834390 (10) [back to overview]Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02834390 (10) [back to overview]Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT02873338 (10) [back to overview]Time to Platelet Recovery
NCT02873338 (10) [back to overview]Number of Subjects Who Died by Day 60.
NCT02873338 (10) [back to overview]Number of Subjects Who Died by Day 30
NCT02873338 (10) [back to overview]Number of Subjects Who Achieved Composite Complete Remission
NCT02873338 (10) [back to overview]Duration of Morphologic Complete Remission
NCT02873338 (10) [back to overview]Duration of Event-free Survival
NCT02873338 (10) [back to overview]Number of Subjects Who Achieved Morphologic Complete Remission
NCT02873338 (10) [back to overview]Time to Recovery of Neutrophils
NCT02873338 (10) [back to overview]Time to Leukemia-free Survival
NCT02873338 (10) [back to overview]Number of Subjects Who Died by Day 90
NCT03860844 (13) [back to overview]Number of Participants With Infusion Reactions (IRs)
NCT03860844 (13) [back to overview]Overall Response Rate (ORR)
NCT03860844 (13) [back to overview]Percentage of Participants With Complete Response (CR) Rate
NCT03860844 (13) [back to overview]AML: Ceoi of Isatuximab
NCT03860844 (13) [back to overview]AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
NCT03860844 (13) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
NCT03860844 (13) [back to overview]Cluster of Differentiation (CD)38 Receptor Density
NCT03860844 (13) [back to overview]B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
NCT03860844 (13) [back to overview]CD38 Receptor Occupancy
NCT03860844 (13) [back to overview]AML: AUC of Isatuximab
NCT03860844 (13) [back to overview]B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab
NCT03860844 (13) [back to overview]B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab
NCT03860844 (13) [back to overview]CD38 Receptor Occupancy

Overall Response Rate (ORR)

Percentage of participants with complete response following treatment out of all participants in that particular treatment group. Response assessed by blood test or bone marrow aspirate following day 21 of induction and then every 2 weeks thereafter until remission or non-response. Complete remission (CR): Disappearance all clinical and/or radiologic evidence of disease; Neutrophil count > 1.0 x10^9/L and platelet count >100x10^9/L, and normal bone marrow differential (< 5% blasts). Complete remission without platelet recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of > 20 x 10^9/L and < 100 x 10^9/L. Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of > 50% and not more than 6-25% abnormal cells in the marrow. All other responses considered as failures. (NCT00067028)
Timeframe: Up to 6 years

InterventionPercentage of Participants (Number)
Clofarabine + Ara-C36
Clofarabine + Idarubicin44
Clofarabine + Idarubicin + Ara-C24

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Participants With a Response

Response assessed by blood test or bone marrow aspirate following day 21 of induction and then every 2 weeks thereafter until remission or non-response. Complete remission (CR): Disappearance all clinical and/or radiologic evidence of disease; Neutrophil count > 1.0 x10^9/L and platelet count >100x10^9/L, and normal bone marrow differential (< 5% blasts). Complete remission without platelet recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of > 20 x 10^9/L and < 100 x 10^9/L. Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of > 50% and not more than 6-25% abnormal cells in the marrow. All other responses considered as failures. (NCT00067028)
Timeframe: Up to 6 years

,,
Interventionparticipants (Number)
CRCRpPR
Clofarabine + Ara-C420
Clofarabine + Idarubicin951
Clofarabine + Idarubicin + Ara-C1671

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Number of Participants With Complete Response

Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L. (NCT00096122)
Timeframe: 21 Day Cycle

InterventionParticipants (Number)
CRCRp
Idarubicin, Cytarabine + Tipifarnib619

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Complete Response (CR) Rate

"Response defined as CR (marrow with <5% blasts and no abnormal promyelocytes together with neutrophil count >1000 and platelet count >100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy.~Bone marrow aspirate performed to check the status of the disease." (NCT00413166)
Timeframe: 1 month, up to day 85 of treatment

InterventionParticipants (Count of Participants)
ATRA + ATO: Low Risk (WBC<10,000)55
ATRA+ATO+IDA: High Risk (WBC >10,000)5
ATO+ATRA+GO15

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Overall Survival (OS)

Overall Survival (OS) was calculated with Kaplan-Meier estimates. OS was calculated from the time of treatment initiation until death. (NCT00422591)
Timeframe: Until death or loss of follow-up

InterventionMonths (Median)
Idarubicin + Cytarabine11.3

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Event-Free Survival (EFS)

Event -Free Survival (EFS) EFS was calculated with Kaplan-Meier estimates. Event-free survival (EFS), defined as the time to no response to intensive induction therapy, relapse, or death of any cause, whichever comes first. (NCT00422591)
Timeframe: from treatment initiation until treatment failure, relapse, or death

InterventionMonths (Median)
Idarubicin + Cytarabine4.7

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Number of Patients Reaching Complete Hematological Response After Induction Therapy

(NCT00458848)
Timeframe: At the end of induction, day +50

Interventionparticipants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy49

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Percentage of Participants Reaching Disease Free Survival

(NCT00458848)
Timeframe: At 60 months

Interventionpercentage of participants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy45.8

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Percentage of Participants Reaching Overall Survival

Overall survival from diagnosis (NCT00458848)
Timeframe: At 60 months

Interventionpercentage of patients (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy48.8

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>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points

FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient (NCT00469859)
Timeframe: Course 1 day 7, day 14, day 21, and day 28.

Interventionparticipants (Number)
Group 1 (Lestaurtinib Dose 50 mg/m25
Group 2 (Lestaurtinib: Dose 62.5 mg/m25

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Dose-limiting Toxicity

Number of patients with dose-limiting toxicity (DLT) (NCT00469859)
Timeframe: 28 days

Interventionparticipants (Number)
Group 1 (Lestaurtinib Dose 50 mg/m20
Group 2 (Lestaurtinib: Dose 62.5 mg/m20

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Molecular Remission Rate

# of patients with Complete Remission (NCT00528450)
Timeframe: 2 years

Interventionparticipants (Number)
All Patients1

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Disease-Free Survival at 2-Year Post-Transplant

Kaplan-Meier estimates at 2-years post-transplant, with 95% confidence intervals based on logit limit transformation of Greenwood's variance. Outcome is death or relapse, censor is alive in continual complete remission at the date of last clinical disease assessment. (NCT00534469)
Timeframe: Estimate at 2 years post treatment

InterventionProportion of pts alive in remission (Number)
HD ARA-C Intermediate Cytogenetics0.65

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Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk

Kaplan-Meier estimates at 2-years post-transplant, with 95% confidence intervals based on logit limit transformation of Greenwood's variance. Outcome is death or relapse, censor is alive in continual complete remission at the date of last clinical disease assessment. (NCT00534469)
Timeframe: Kaplan-Meier estimate 2 years post treatment

InterventionProportion of pts alive in remission (Number)
Unfavorable Risk Cytogenetics0.33
Intermediate Risk Cytogenetics0.75
Favorable Risk Cytogenetics0.75
Unknown Risk: Rejected Cytogenetics Study0.73

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Maximum Tolerated Dose (MTD)

MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0. (NCT00542971)
Timeframe: Twice a week for first two 28 day cycles

Interventionmilligrams/twice a day (BID) (Number)
Sorafenib + Idarubicin + Ara-C400

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Number of Participants With Complete Response

Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB). (NCT00542971)
Timeframe: Baseline to 2 years or disease progression.

InterventionParticipants (Number)
Complete ResponseNo Complete Response
Sorafenib + Idarubicin + Ara-C5421

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Percentage of Participants With Response to LY2181308 Sodium in Combination With Idarubicin and Cytarabine (Remission Rates)

Response is complete remission (CR) + CR with incomplete blood count recovery (CRi) + partial remission (PR) + cytoreduction. CR: fewer than 5% blasts based on a cell count of at least 200 cells from a bone marrow aspirate containing bone marrow spicules, in the setting of peripheral blood recovery to: platelets ≥100x10⁹/liter (L), neutrophils ≥10⁹/L. PR: defined as a decrease of at least 50% in blast count on the bone marrow aspirate; or cytoreduction (defined as a decrease in blast count not meeting the criteria for a PR or CR). Response rate is calculated as a total number of participants with CR or CRi or PR or cytoreduction divided by the total number of participants treated multiplied by 100. (NCT00620321)
Timeframe: Baseline to progression of disease or death up to 6 months

Interventionpercentage of participants (Number)
LY21813080
LY2181308 + Idarubicin + Cytarabine56.3

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Change From Baseline in Survivin Index at Day 2

Data presented are the ratio of Day 2 survivin index to the baseline survivin index. Survivin is a protein expressed in tumor cells, including acute myeloid leukemia (AML), which regulates mitosis and prevents tumor cell death. Survivin index was calculated as ([blast survivin mean equivalent fluorochrome (MEFL) - blast isotypic control MEFL]/blast isotypic control MEFL). (NCT00620321)
Timeframe: Baseline, Day 2

Interventionratio (Least Squares Mean)
LY21813080.43

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Area Under the Curve of LY2181308 Over the Dosing Interval

Area under the curve of LY2181308 over the dosing interval (NCT00620321)
Timeframe: Day 3: 0,12,24,36,48,60,72,84,96,108,120,132 hours

Interventionnanograms*hour/milliliter (ng*h/mL) (Geometric Mean)
LY2181308216947
LY2181308 + Idarubicin + Cytarabine185734

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Number of Participants With Adverse Events (Safety Profile)

Data are presented as number of participants who experienced serious adverse events (SAE) and possibly drug-related treatment-emergent adverse events (TEAE) during the study including the 21-day follow-up period. A summary of serious adverse events and other nonserious adverse events regardless of causality is located in the Reported Adverse Events section. (NCT00620321)
Timeframe: Start of treatment to study completion up to 6.7 months

,
InterventionParticipants (Count of Participants)
SAEDrug-related TEAE
LY218130862
LY2181308 + Idarubicin + Cytarabine1311

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Number of Participants Who Died Due to Progressive Disease or Unknown Cause During the 21 Days Post Study Treatment Follow-Up

Deaths due to progressive disease (PD) and unknown cause are not considered adverse events. Deaths due to PD and unknown cause occurring during the 21-day follow-up period after treatment discontinuation are reported here and for those occurring while participants were on treatment are reported in the Participant Flow. Deaths due to serious adverse events occurred during the study including the 21-day follow-up period are reported in the Reported Adverse Events section. (NCT00620321)
Timeframe: Study treatment discontinuation up to 21 days post study treatment discontinuation

,
InterventionParticipants (Count of Participants)
Death due to progressive diseaseDeath due to unknown cause
LY218130811
LY2181308 + Idarubicin + Cytarabine00

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Pharmacodynamics: Number of Participants With Survivin Protein Expression

Pharmacodynamics: Number of participants with Survivin Protein Expression. (NCT00620321)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
LY21813082

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Progression Free Survival (PFS) at 7 Months

Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months. (NCT00656617)
Timeframe: PFS Evaluation at 7 months

Interventionpercentage of participants (Number)
Idarubicin + Ara-C + Vorinostat65

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Participant Response

Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response. (NCT00656617)
Timeframe: Monitoring with each 4 week cycle, up to 18 cycles of treatment

Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Complete Response without platelet recovery (CRp)Progressive Disease (PD)No response
Idarubicin + Ara-C + Vorinostat67011024

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Proteasome Inhibition Activity

Mean and standard deviation of β1 and β5- Results are ratios (proteasome subunit/β-actin based on loading of 15 µg total protein, normalized to CEM). (NCT00666588)
Timeframe: At baseline

,,
Interventionratio (Mean)
Baseline β1Baseline β5
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp0.78940.2576
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp0.28951430.3721286
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0.081150.121575

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Dose Limiting Toxicity

Number of participants with dose limiting toxicity. (NCT00666588)
Timeframe: During Course 1

Interventionparticipants (Number)
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp1
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp0
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp0

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Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1

Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1. (NCT00666588)
Timeframe: After course 1

Interventionparticipants (Number)
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure4
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp2
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp2
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp9

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Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion

Descriptive statistics to assess mean +/- standard deviation for the percentage leukemia initiation cells (LIC) depletion. (NCT00666588)
Timeframe: At baseline and after completion of course 1

,,
Interventionpercentage of LIC depletion (Mean)
Prior to TreatmentPost Treatment
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp1.63850.0435
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp0.20.43
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0.0136670.021

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NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)

NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response. (NCT00666588)
Timeframe: At baseline, prior to and up to 24 hours after bortezomib treatment

,,,
Interventionng/Mg protein (Mean)
Baseline24 Hrs after treatment
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp655.4345.46
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp408.144497.31
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp974.66855.96
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure718.218774.1925

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Median Overall Survival (OS)

Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure. (NCT00831766)
Timeframe: Up to 24 Months

Interventionmonths (Median)
All Participants Treated at MTD11.22

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Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)

Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL). (NCT00831766)
Timeframe: 24 months

Interventionpercentage of participants (Number)
All Participants Treated at MTD54

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Median Progression-Free Survival (PFS)

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. (NCT00831766)
Timeframe: 24 months

Interventionmonths (Median)
All Participants Treated at MTD7.55

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Overall Survival (OS)

OS is calculated for all participants from the date of initial registration on study until death from any cause. Observations for participants last known to be alive were censored. (NCT00840177)
Timeframe: OS assessed for up to 5 years, median OS reported

Interventionmonths (Median)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month10
Poor-risk Cohort: MDS Transformed to AML10
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission4

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Relapse-free Survival (RFS)

"RFS is calculated for participants who have achieved a complete response (CR) or CR with incomplete blood count recovery (CRi). RFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL." (NCT00840177)
Timeframe: RFS assessed for up to 5 years, median RFS reported

Interventionmonths (Median)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month9
Poor-risk Cohort: MDS Transformed to AML19.4
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission2.7

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Frequency and Severity of Toxicity as Assessed by NCI CTCAE Version 3.0

Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event (NCT00840177)
Timeframe: Up to 5 years post registration

,,
InterventionParticipants (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AST, SGOTAcidosis (metabolic or respiratory)Albumin, serum-low (hypoalbuminemia)Alkaline phosphataseAlkalosis (metabolic or respiratory)AnorexiaBilirubin (hyperbilirubinemia)Blood/Bone Marrow-Other (Specify)Bone marrow cellularityCalcium, serum-low (hypocalcemia)Carbon monoxide diffusion capacity (DL(co))Cardiac General-Other (Specify)Cardiac-ischemia/infarctionColitis, infectious (e.g., Clostridium difficile)Conduction abnormality - AsystoleConfusionConstitutional Symptoms-Other (Specify)CreatinineDiarrheaDistention/bloating, abdominalDry mouth/salivary gland (xerostomia)Dyspnea (shortness of breath)Edema: limbEsophagitisFatigue (asthenia, lethargy, malaise)Febrile neutropeniaGlucose, serum-high (hyperglycemia)HemoglobinHemorrhage, GI - DuodenumHemorrhage, GU - VaginaHemorrhage, pulmo/upper resp- Bronchopulmonary NOSHemorrhage, pulmonary/upper respiratory - NoseHemorrhage/Bleeding-Other (Specify)HypertensionHypotensionHypoxiaIleus, GI (functional obstruction of bowel)Inf (clin/microbio) w/Gr 3-4 neuts - BloodInf (clin/microbio) w/Gr 3-4 neuts - BronchusInf (clin/microbio) w/Gr 3-4 neuts - KidneyInf (clin/microbio) w/Gr 3-4 neuts - LungInf (clin/microbio) w/Gr 3-4 neuts - MeningesInf (clin/microbio) w/Gr 3-4 neuts - SinusInf (clin/microbio) w/Gr 3-4 neuts - SkinInf (clin/microbio) w/Gr 3-4 neuts - Small bowelInf (clin/microbio) w/Gr 3-4 neuts - StomachInfection with unknown ANC - BloodInfection with unknown ANC - Lung (pneumonia)Infection with unknown ANC - MucosaInfection with unknown ANC - SinusInfection with unknown ANC - Small bowel NOSInfection-Other (Specify)Left ventricular diastolic dysfunctionLeukocytes (total WBC)LipaseLymphopeniaMagnesium, serum-high (hypermagnesemia)Mental statusMucositis/stomatitis (clinical exam) - Oral cavityMucositis/stomatitis (clinical exam) - PharynxMucositis/stomatitis (functional/symp) - Oral cavMusculoskeletal/Soft Tissue-Other (Specify)NauseaNecrosis, GI - Small bowel NOSNeutrophils/granulocytes (ANC/AGC)Obstruction, GI - Small bowel NOSOcular/Visual-Other (Specify)Opportunistic inf associated w/gt=Gr 2 lymphopeniaPain - Abdomen NOSPain - BonePain - EsophagusPain - Extremity-limbPain - Oral cavityPain - PeritoneumPhosphate, serum-low (hypophosphatemia)PlateletsPleural effusion (non-malignant)Potassium, serum-high (hyperkalemia)Potassium, serum-low (hypokalemia)Pulmonary hypertensionPulmonary/Upper Respiratory-Other (Specify)Rash/desquamationRenal failureRenal/Genitourinary-Other (Specify)SVT and nodal arrhythmia - Atrial fibrillationSVT and nodal arrhythmia - Atrial flutterSodium, serum-high (hypernatremia)Sodium, serum-low (hyponatremia)Syncope (fainting)Typhlitis (cecal inflammation)Ulcer, GI - DuodenumUlcerationVomitingWeight loss
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month0001001221211001100300201320111010011111410501010100101216160100102014010100000217006100001111100020
Poor-risk Cohort: MDS Transformed to AML2313011210540110023421120218214100000222400200100210011011051000011115100300001416123010011000001020
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission2106100000310010002800200232021001100130711610001401000017090011103016002011130219003001200001010102

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Complete Remission (CR) Rate (Including CR With Incomplete Recovery)

"Participants who achieved morphological complete remission with or without incomplete blood count recovery.~Per the Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia, morphologic complete remission requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL." (NCT00840177)
Timeframe: Up to 5 years after registration

InterventionParticipants (Count of Participants)
Initial Cohort: Relapsed AML With Previous Remission ≥ 3 Month27
Poor-risk Cohort: MDS Transformed to AML14
Poor-risk Cohort: Refractory/Relapsed AML, < 6 Mths Remission14

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Event-free Survival (EFS)

EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol. (NCT00866918)
Timeframe: At 3 years from study entry

InterventionPercentage of participants (Number)
Standard Risk95.4
High Risk82.9

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Hematologic Remission Rate

Proportion of patients in hematologic remission at end of consolidation, course 1 are reported. (NCT00866918)
Timeframe: End of consolidation, course 1: up to 5 months

InterventionProportion of participants (Number)
Standard Risk1.0000
High Risk0.8824

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Overall Survival (OS)

OS - time from study entry to death. (NCT00866918)
Timeframe: At 3 years from study entry

InterventionPercentage of participants (Number)
Standard Risk98.4
High Risk85.7

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Hematologic, Molecular, and Cytogenetic Remission Rate

Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria. (NCT00866918)
Timeframe: End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)

InterventionProportion of participants (Number)
Standard Risk0.8095
High Risk0.5882

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Overall Survival

Overall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored. (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

InterventionWeeks (Median)
Arm A, Step 410
Arm B, Steps 1-64.9
Arm B, Step 73.7
Arm B, Step 93.9

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Relapse-Free Survival

Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause. (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

InterventionWeeks (Number)
Arm A, Step 226.3
Arm A, Step 320.6
Arm A, Step 428.1
Arm B, Step 730.3
Arm B, Step 96.1

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Remission Duration

Remission duration: time (weeks) from date of remission status to disease relapse. (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

InterventionWeeks (Mean)
Arm A, Step 226.3
Arm A, Step 320.6
Arm B, Steps 1-65.4
Arm B, Step 730.3
Arm B, Step 819.6
Arm B, Step 93.0

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Time to Response (CR and PR)

Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR) (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

InterventionWeeks (Median)
Arm A, Step 22.6
Arm A, Step 37.9
Arm A, Step 46.0
Arm B, Steps 1-64.0
Arm B, Step 71.9
Arm B, Step 84.0
Arm B, Step 91.0

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Event-Free Survival

Event-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause. (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

InterventionWeeks (Median)
Arm A, Step 15.1
Arm A, Step 23.1
Arm A, Step 38.0
Arm A, Step 46.5
Arm B, Steps 1-62.0
Arm B, Step 75.4
Arm B, Step 85.4
Arm B, Step 96.4

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Elimination t½

(NCT00878722)
Timeframe: Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion

InterventionHours (Mean)
Arm A, Cycle 1 Day 412.7
Arm A, Cycle 1 Day 513.1
Arm B, Cycle 1 Day 1 and Day 24.21

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Duration of Response (CR and PR)

Duration of Response (CR and PR) in Weeks (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

Interventionweeks (Mean)
Arm A, Step 226.3
Arm A, Step 320.6
Arm A, Step 428.1
Arm B, Steps 1-65.4
Arm B, Step 730.3
Arm B, Step 819.6
Arm B, Step 94.3

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Belinostat Cmax

Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2 (NCT00878722)
Timeframe: Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion

Interventionng/mL (Mean)
Arm A, Cycle 1 Day 438744
Arm A, Cycle 1 Day 531952
Arm B, Cycle 1 Day 1 and Day 29657

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Belinostat AUC (Area Under Curve)

(NCT00878722)
Timeframe: Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion

Interventionng*hrs/mL (Mean)
Arm A, Cycle 1 Day 421850
Arm A, Cycle 1 Day 521322
Arm B, Cycle 1 Day 1 and Day 2172823

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Maximum Tolerated Dose, Dose Limiting Toxicity

DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle (NCT00878722)
Timeframe: First Cycle

Interventionparticipants (Number)
Arm A, Step 10
Arm A, Step 20
Arm A, Step 30
Arm A, Step 40
Arm B, Steps 1-60
Arm B, Step 70
Arm B, Step 80
Arm B, Step 90

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Overall Response

Efficacy measured as Response rate (complete response ([CR] and Complete remission with incomplete recovery of platelets [CRi]) and partial response ([PR])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission). (NCT00878722)
Timeframe: Throughout study, after each cycle for the first two cycles, then after every second cycle

Interventionparticipants (Number)
Arm A, Step 10
Arm A, Step 21
Arm A, Step 31
Arm A, Step 41
Arm B, Steps 1-61
Arm B, Step 71
Arm B, Step 81
Arm B, Step 93

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Median Event-Free Survival (EFS)

Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death. Bayesian time-to-event model will be used to monitor progression free survival. (NCT01025154)
Timeframe: 2 years

InterventionMonths (Median)
Clofarabine, Cytarabine + Idarubicin13.5

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Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery

Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy. (NCT01025154)
Timeframe: 8 weeks after Induction therapy (induction cycle 4-6 weeks)

Interventionparticipants (Number)
Complete RemissionComplete Remission without Platelet Recovery
Clofarabine, Cytarabine + Idarubicin423

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Disease-free Survival (DFS)

In a five year following, the disease free survival was obtained. (NCT01141725)
Timeframe: 5 years

Interventiondays (Median)
Treatment (Combination Chemotherapy)235

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Maximum Tolerated Dose

A bayesian approach to estimate the MTD of bendamustine associated with a CR rate of at least 40% and with <30% grade 3-4 non-haematological toxicity was used (Wathen et al, 2008).The MTD of bendamustine in combination with idarubicin was determined after two cases of grade 3 toxicity were noted in the three patients entered at the 75 mg/m2 dose. The DLTs were congestive heart failure and mucositis in one patient each. Patients subsequent to this were treated at the 60 mg/m2 bendamustine dose. (NCT01141725)
Timeframe: 6 months

Interventionmg/m2 (Number)
Treatment (Combination Chemotherapy)60

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Median Survival

In a five year following, the median survival was obtained. (NCT01141725)
Timeframe: 5 years

Interventionmonths (Median)
Treatment (Combination Chemotherapy)7.2

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Incidence of Greater Than or Equal to Grade 3 Toxicity

Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0. (NCT01141725)
Timeframe: Up to day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier

InterventionParticipants (Count of Participants)
Treatment A0
Treatment B0
Treatment C2

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Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI)

NCI & Myelodysplastic syndromes (MDS) International Working Group (IWG) Definitions: Complete Response (CR): Neutrophil count ≥1.0 ×10^9/L, Platelet count ≥100 ×10^9/L, Bone marrow aspirate 10% after initial response. Response assessed Day 28 of every 2-3 cycles during treatment. (NCT01289457)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Group 1 CIA107
Group 2 FLAI76

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT01289457)
Timeframe: up to 2 years

InterventionMonths (Median)
Group 1 CIA14.5
Group 2 FLAI15.1

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Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine

MTD is highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicities (DLT). Toxicity defined as any treatment-related grade 3 or greater non-hematological toxicities. (NCT01289457)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Clofarabine + Idarubicin + Cytarabine15

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Event-Free Survival (EFS) at 2 Years

Comparison of the event-free survival (EFS) between treatment CIA and FLAI, where an event is defined to be resistance to treatment, relapse (after response) or death, whichever occurred first. (NCT01289457)
Timeframe: Up to 2 years or until relapse/death

InterventionMonths (Median)
Group 1 CIA7.1
Group 2 FLAI8.4

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Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000

(NCT01607645)
Timeframe: Assessed for up to 5 years

Interventiondays (Mean)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)51

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Duration of Severe Neutropenia Defined as an ANC Less Than 500

(NCT01607645)
Timeframe: Assessed for up to 5 years

Interventiondays (Mean)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)65

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Duration of Moderate Neutropenia Defined as an ANC Less Than 1000

(NCT01607645)
Timeframe: Assessed for up to 5 years

Interventiondays (Mean)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)67

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Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction

(NCT01607645)
Timeframe: Assessed for up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)3
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers

(NCT01607645)
Timeframe: Assessed for up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)0
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers

(NCT01607645)
Timeframe: Assessed for up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)2
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL

(NCT01607645)
Timeframe: Assessed for up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)0
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers

(NCT01607645)
Timeframe: Assessed for up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)1
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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Number of Participants Who Achieved Morphologic CR

Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease (NCT01607645)
Timeframe: Participants were monitored up until the point when they went off study following completion of the treatment (3 months)

,
Interventionparticipants (Number)
CRCRi-MRD (Minimal Residual Disease)Refractory
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)211
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)003

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Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0

(NCT01607645)
Timeframe: Assessed for up to 3 months after completion study treatment

,
InterventionParticipants (Count of Participants)
CYCLE 1 : Infection Grade 3CYCLE 1 : Infection Grade 4CYCLE 1 : Hepatobiliary Grade 3CYCLE 1 : Blood and Lymphatic Grade 3CYCLE 1 : Gastrointenstinal Grade 3CYCLE 2 : Infection Grade 3CYCLE 2 : Infection Grade 4CYCLE 2 : Hepatobiliary Grade 3CYCLE 2 : Blood and Lymphatic Grade 3CYCLE 2 : Gastrointenstinal Grade 3
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)2003000011
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0111000000

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TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine

(NCT01607645)
Timeframe: Assessed for up to Day 30

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)0
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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Severe Prolonged Aplasia

(NCT01607645)
Timeframe: Assessed for up to 45 days

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)0
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)0

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Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM

(NCT01607645)
Timeframe: Assessed for up to 90 days

InterventionParticipants (Count of Participants)
Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)1
Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)3

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Disease-free Survival

Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT01692197)
Timeframe: Up to 5 years

Interventionmonths (Median)
E7070 + Idarubicin + Cytarabine1.7

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Duration of Response

Response date to loss of response or last follow up. (NCT01692197)
Timeframe: Up to 5 years

Interventionmonths (Median)
E7070 and Idarubicin and Cytarabine6.7

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Overall Response

Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1. (NCT01692197)
Timeframe: 2 cycles (60 days)

InterventionParticipants (Count of Participants)
E7070 and Idarubicin and Cytarabine11

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Overall Survival

Time from date of treatment start until date of death due to any cause or last follow-up. (NCT01692197)
Timeframe: Up to 5 years

Interventionmonths (Median)
E7070 and Idarubicin and Cytarabine5.1

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To Determine the Disease-free Survival (DFS).

Time from date of treatment start until the date of first objective documentation of return of disease. (NCT01794702)
Timeframe: Up to 2 years after participants off study date

Interventionmonths (Median)
Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin17.9

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT01794702)
Timeframe: Up to 2 years after participants off study date

InterventionMonths (Median)
Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin7.7

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Number of Participants With a Response

Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days. (NCT01794702)
Timeframe: 56 days

InterventionParticipants (Count of Participants)
Phase II Clofarabine + Cytarabine + Decitabine + Idarubicin20

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Maximum Tolerated Dose (MTD) of Clofarabine

Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion). (NCT01794702)
Timeframe: After second, 33 day cycle

Interventionmg/m^2 x 4 days (6-9) (Number)
Period 115

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EFS of Arm I Compared to Arm II

"EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi.~A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates.~2-year EFS by arm will be estimated using the Kaplan-Meier method." (NCT01802333)
Timeframe: EFS assessed for up to 5 years, 2 year EFS reported

InterventionProportion of participants (Number)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)0.36
Arm II (High-dose Cytarabine, Idarubicin)0.41

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Event-free Survival (EFS)

"EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi.~2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression." (NCT01802333)
Timeframe: EFS assessed for up to 5 years, 2 year EFS reported

InterventionProportion of participants (Number)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)0.36
Arm II (High-dose Cytarabine, Idarubicin)0.41
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)0.37

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Overall Survival (OS)

"To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.~2-year OS by arm will be estimated using the Kaplan-Meier method." (NCT01802333)
Timeframe: OS assessed for up to 5 years, 2 year OS reported

InterventionProportion of participants (Number)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)0.56
Arm II (High-dose Cytarabine, Idarubicin)0.59
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)0.58

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Prevalence of the Mutation NPM1 in Patients on This Study.

To estimate the prevalence of the mutation NPM1 in this patient population. (NCT01802333)
Timeframe: Baseline

Interventionpercentage of patients (Number)
All Arms Combined33

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Rate of Allogeneic HCT

The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted. (NCT01802333)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
High Risk Patients in First Complete Remission65

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Cytogenetic Risk Distribution of Patients on This Study

To estimate the cytogenetic risk distribution of patients on this study. (NCT01802333)
Timeframe: Baseline

Interventionpercentage of participants (Number)
High riskIntermediate riskLow risk
All Arms Combined22.364.213.5

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Frequency and Severity of Toxicities

Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event. (NCT01802333)
Timeframe: Up to 5 years

,,
InterventionParticipants (Count of Participants)
Abdominal distensionAbdominal infectionAbdominal painAcidosisAcute kidney injuryAdult respiratory distress syndromeAlanine aminotransferase increasedAlkaline phosphatase increasedAlkalosisAllergic reactionAnal hemorrhageAnal painAnal ulcerAnemiaAnorectal infectionAnorexiaAspartate aminotransferase increasedAtelectasisAtrial fibrillationAtrial flutterAtrioventricular block completeBlood and lymphatic system disorders - OtherBlood bilirubin increasedBone infectionBone painBronchopulmonary hemorrhageBullous dermatitisCD4 lymphocytes decreasedCardiac arrestCardiac disorders - Other, specifyCardiac troponin I increasedCatheter related infectionChillsChronic kidney diseaseCognitive disturbanceColitisColonic hemorrhageColonic perforationConduction disorderConfusionConjunctivitisConstipationConstrictive pericarditisCreatinine increasedDeath NOSDehydrationDental cariesDevice related infectionDiarrheaDisseminated intravascular coagulationDry mouthDry skinDuodenal hemorrhageDyspepsiaDysphagiaDyspneaEdema cerebralEdema limbsEjection fraction decreasedElectrocardiogram QT corrected interval prolongedEncephalopathyEnterocolitisEnterocolitis infectiousEpistaxisErythema multiformeErythrodermaEsophageal hemorrhageEsophageal painEsophagitisEye infectionFatigueFebrile neutropeniaFeverGGT increasedGait disturbanceGastric hemorrhageGastritisGastroesophageal reflux diseaseGastrointestinal disorders - Other, specifyGeneral disorders and admin site conditions-OtherGeneralized muscle weaknessGenital edemaGlucose intoleranceGum infectionHeadacheHeart failureHematomaHematuriaHepatic failureHepatic infectionHepatobiliary disorders - Other, specifyHyperglycemiaHyperhidrosisHyperkalemiaHypermagnesemiaHypernatremiaHypertensionHyperuricemiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaIleusInfections and infestations - Other, specifyInfective myositisInjury, poison and procedural complications-OtherIntracranial hemorrhageInvestigations - Other, specifyIrregular menstruationJejunal obstructionKidney infectionLaryngeal edemaLaryngeal mucositisLeft ventricular systolic dysfunctionLeukocytosisLipase increasedLower gastrointestinal hemorrhageLung infectionLymphocyte count decreasedMenorrhagiaMetabolism and nutrition disorders-Other, specifyMiddle ear inflammationMucosal infectionMucositis oralMulti-organ failureMusculoskeletal and connective tiss disorder-OtherMyalgiaNauseaNeck edemaNervous system disorders - Other, specifyNeutrophil count decreasedNon-cardiac chest painOral painPainPain in extremityPalmar-plantar erythrodysesthesia syndromePapulopustular rashParesthesiaPericardial effusionPericardial tamponadePeriorbital edemaPeripheral sensory neuropathyPharyngeal mucositisPharyngitisPlatelet count decreasedPleural effusionPneumonitisPruritusPulmonary edemaPurpuraRash acneiformRash maculo-papularRectal hemorrhageRectal painRenal and urinary disorders - Other, specifyResp, thoracic and mediastinal disorders - OtherRespiratory failureRestrictive cardiomyopathySalivary duct inflammationScrotal infectionScrotal painSeizureSepsisSinus bradycardiaSinus tachycardiaSinusitisSkin and subcutaneous tissue disorders - OtherSkin infectionSkin ulcerationSmall intestinal obstructionSoft tissue infectionSore throatStomach painStrokeSupraventricular tachycardiaSyncopeTesticular disorderThromboembolic eventThrombotic thrombocytopenic purpuraTooth infectionTumor lysis syndromeTyphlitisUpper gastrointestinal hemorrhageUpper respiratory infectionUrinary incontinenceUrinary tract infectionUrine output decreasedVaginal hemorrhageVascular access complicationVasovagal reactionVentricular tachycardiaVomitingWeight lossWhite blood cell decreasedWound infection
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)114121122100001580580000191010111031003201010111111152001113002001121001301415243001110201123001115100070580180202132018110110010210021891111191007001411511000000011175110101111101311001160020501111002013148120500000321561
Arm II (High-dose Cytarabine, Idarubicin)016153172100101640161503111150112131170209000201061003201120017036216410001211816072020054100022120101211106181702012031124121000600100310122107010018310150112805002100010001680412112600138000002602021000201121000814010200211601500
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)119244201221011064121211100220030021040015110000040300381000008124205420110101311464130011210043000011601026182512429319921400130100101231477000111511510104100110111010012812150010010214001113412014100201130010923121612110421120

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Complete Response (CR) Rate

"To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~Complete response is defined as: ANC >= 1,000/mcl, platelet count >= 100,000/mcl, < 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration)" (NCT01802333)
Timeframe: Up to 5 years

InterventionPercentage of participants (Number)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)75
Arm II (High-dose Cytarabine, Idarubicin)80
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)77

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Disease-free Survival (DFS)

"To compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~2-year DFS by arm will be estimated using the Kaplan-Meier method." (NCT01802333)
Timeframe: DFS assessed for up to 5 years, 2 year DFS reported

InterventionProportion of participants (Number)
Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride)0.48
Arm II (High-dose Cytarabine, Idarubicin)0.51
Arm III (Vorinostat, High-dose Cytarabine, Idarubicin)0.46

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Disease-free Survival (DFS) Among High Risk Patients

"DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~2-year DFS for high risk patients will be estimated using the Kaplan-Meier method." (NCT01802333)
Timeframe: DFS assessed for up to 5 years, 2 year DFS reported

InterventionProportion of participants (Number)
High Risk Patients0.30

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Progression Free Survival (PFS)

(NCT01831232)
Timeframe: 1 year after treatment with IAP

Interventionpercentage of patients with PFS (Number)
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)52.6

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Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)

Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR) (NCT01831232)
Timeframe: 35 days

InterventionParticipants (Count of Participants)
CRCRiPR
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)1520

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Number of Biomarker-positive Participants With Clinical Responses

"Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A good CR is defined as <5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets >100,00 and absolute neutrophil count >1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease)." (NCT01831232)
Timeframe: 38 days after dosing

Interventionparticipants with clinical responses (Number)
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)0

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Number of Participants With Good Complete Remission (CR)

"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~Definition of Good CR: Conventional criteria for CR (absolute neutrophil count > 1,000/uL, platelet count > 100,000/uL, marrow with <5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained." (NCT01831232)
Timeframe: 35 days

InterventionParticipants (Count of Participants)
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)12

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Number of Participants With TRM.

"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~TRM: Treatment Related Mortality" (NCT01831232)
Timeframe: 28 days

Interventionparticipants (Number)
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)2

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Overall Survival

Amount of time a patient lives after treatment with IAP (NCT01831232)
Timeframe: 1 year after treatment with IAP

Interventionpercentage of patients surviving (Number)
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)53.5

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Maximum Tolerated Dose of Dasatinib (Phase I)

Maximum tolerated dose of dasatinib, determined according to incidence of dose limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) (NCT01876953)
Timeframe: From the first dose of Dasatinib through the DLT observation period (Day +28)

Interventionmg/m2 (Number)
Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day100

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Percentage of Subjects With Unacceptable Toxicity

Grade IV CTCAE toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days, Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days, or death (NCT02046122)
Timeframe: 8 weeks after the last cell infusion

Interventionpercentage of participants (Number)
Idarubicin + Cytarabine + DLI5.88

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Number of Participants With Immune Recovery

Immune recovery determined by measurements of cytokine profiles, lymphocyte and natural killer (NK) enumeration and flow-based assays, measured prior to induction, prior to each round of consolidation, 8 weeks after the last cycle of consolidation, and every 3 months after treatment for up to 2 years (NCT02046122)
Timeframe: up to 2 years after completing therapy

InterventionParticipants (Count of Participants)
Idarubicin + Cytarabine + DLI3

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Number of Days to Hematopoietic Recovery

Hematopoietic recovery as measured by the date of the first of three consecutive laboratory values where the absolute neutrophil count (ANC) ≥ 500/μl , the date of the first of three consecutive laboratory values obtained on different days where the platelet count was > 20,000/μl without transfusion. (NCT02046122)
Timeframe: 2 years after completion of therapy

Interventiondays (Median)
Neutrophil recoveryPlatelet recovery
Idarubicin + Cytarabine + DLI2932

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Rate of Efficacy

Efficacy as measured by the number of subjects with a complete remission. Responses were evaluated according to standard criteria defined by the National Comprehensive Cancer Network Guidelines for AML (www.nccn.org). (NCT02046122)
Timeframe: 2 years after completing therapy

InterventionParticipants (Count of Participants)
Idarubicin + Cytarabine + DLI10

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Overall Survival

Number of participants alive 2 years after completing adoptive transfer therapy. (NCT02046122)
Timeframe: 2 years after completing therapy

Interventionparticipants (Number)
Idarubicin + Cytarabine + DLI16

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Number of Subjects With Unacceptable Toxicity

"Unacceptable toxicity is defined as:~i. Grade III or IV acute GVHD (aGVHD) of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days;~ii. Grade IV Common Terminology Criteria for Adverse Events (CTCAE) toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days~iii. Treatment-related mortality (TRM)" (NCT02046122)
Timeframe: up to 8 weeks after last cell infusion

InterventionParticipants (Count of Participants)
Idarubicin + Cytarabine + DLI1

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Disease Free Survival

1 year disease free survival rate following adoptive transfer (NCT02046122)
Timeframe: one year following adoptive transfer

InterventionParticipants (Count of Participants)
Idarubicin + Cytarabine + DLI3

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Percentage of Subjects With Acute GVHD

Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days (NCT02046122)
Timeframe: 8 weeks after last cell infusion

Interventionpercentage of participants (Number)
Idarubicin + Cytarabine + DLI0

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Number of Participants With the Most Frequently Reports Grade 3 or 4 Adverse Event.

The most frequently reported adverse events will be determined by the Principal Investigator. The number of participants who experienced the most frequent grade 3 or 4 adverse events will be reported. (NCT02096055)
Timeframe: Up to 4 years, 3 months

,,,
InterventionParticipants (Count of Participants)
Infection/SepsisFebrile NeutropeniaFatigue
Arm I (Guadecitabine) x 5 Days450
Arm II (CLOSED) (Guadecitabine) x 10 Days820
Arm III (Guadecitabine, Idarubicin)843
Arm IV (CLOSED) (Guadecitabine, Cladribine)990

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Survival

Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. (NCT02096055)
Timeframe: Up to 4 years, 3 months

InterventionMonths (Median)
Arm I (Guadecitabine) x 5 Days13.1
Arm II (CLOSED) (Guadecitabine) x 10 Days13.0
Arm III (Guadecitabine, Idarubicin)15.4
Arm IV (CLOSED) (Guadecitabine, Cladribine)11.9

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Number of Participants With a Complete Response

Complete Response = Complete Remission (CR) + Complete Remission without blood count recovery (CRi) - CR: Neutrophil count >/= 1.0 x 10^9/L and platelet count >/= 100 x 10^9/L, and normal bone marrow differential (NCT02096055)
Timeframe: Up to 4 years, 3 months

InterventionParticipants (Count of Participants)
Arm I (Guadecitabine) x 5 Days5
Arm II (CLOSED) (Guadecitabine) x 10 Days5
Arm III (Guadecitabine, Idarubicin)10
Arm IV (CLOSED) (Guadecitabine, Cladribine)0

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Leukemia-free Survival

Survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups. Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT02096055)
Timeframe: Up to 4 years, 3 months

InterventionMonths (Median)
Arm I (Guadecitabine) x 5 Days4.2
Arm II (CLOSED) (Guadecitabine) x 10 Days10.0
Arm III (Guadecitabine, Idarubicin)7.4
Arm IV (CLOSED) (Guadecitabine, Cladribine)4.3

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Remission Duration

The date of Complete Response to the date of loss of response or last follow-up. (NCT02096055)
Timeframe: Up to 4 years, 3 months

InterventionMonths (Median)
Arm I (Guadecitabine) x 5 Days7.4
Arm II (CLOSED) (Guadecitabine) x 10 Days14.2
Arm III (Guadecitabine, Idarubicin)5.3

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Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients

The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients. (NCT02144675)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Arm I (Choline Magnesium Trisalicylate and Chemotherapy)13
Arm II (Chemotherapy)14

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Number of Participants With CR/CRi = Overall Reponse Rate

"Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of complete response (CR) or morphologic complete response with incomplete blood count recovery (CRi), as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet:~CR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease.~CRi: Same as CR, but ANC may be <1.0x10^9/L and/or Platelet count <100x10^9/L.~Patients with morphologic leukemia free-state (MLFS) were included in the group of responders. MLFS: Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease.~The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s)." (NCT02249091)
Timeframe: 1-2 induction cycles (4 - 8 weeks)

InterventionParticipants (Count of Participants)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin15
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin6

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Event-Free Survival

Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi. (NCT02249091)
Timeframe: Time from registration to event, max 2 years

Interventionmonths (Median)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin5.6
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin4.3

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Early Death Rate

Early death was defined as death before the end of the first induction cycle. (NCT02249091)
Timeframe: 1 induction cycle (4 weeks)

InterventionParticipants (Count of Participants)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin0
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin4

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Progression-Free Survival

"Progression-free survival (PFS) was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.~Disease progression was defined as presence of >50% increase in bone marrow blasts to a level of at least 50% and/or a doubling of the percentage of peripheral blood blasts to a level of at least 50%." (NCT02249091)
Timeframe: Time from registration to event, max 2 years

Interventionmonths (Median)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin6.3
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin4.3

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Relapse-Free Survival

Relapse-free survival (RFS) was calculated from the date of CR/CRi until death or relapse, whichever occurred first. Patients were censored on the date of the last follow-up if they were alive without relapse. (NCT02249091)
Timeframe: Time from registration to event, max 2 years

Interventionmonths (Median)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin10.9
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and IdarubicinNA

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Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation)

Percentage of patients being transplanted after induction therapy (stem cell transplantation) (NCT02249091)
Timeframe: 1-2 induction cycles (4 - 8 weeks)

InterventionParticipants (Count of Participants)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin11
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin4

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Overall Survival

Overall survival (OS) was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. (NCT02249091)
Timeframe: Time from registration to event, max 2 years

Interventionmonths (Median)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin12.6
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin8.0

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Number of Participants With Partial Remission (PR) = Rate of PR

"Efficacy of selinexor in combination with standard chemotherapy in patients with relapsed/refractory AML by determination of rate of partial remission(PR) as defined by the recommendations on diagnosis and management of AML in adults from an international expert panel, on behalf of the European LeukemiaNet:~PR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.~The best response after Selinexor treatment was analyzed, thus the best response after the induction cycle(s)." (NCT02249091)
Timeframe: 1-2 induction cycles (4 - 8 weeks)

InterventionParticipants (Count of Participants)
Cohort 1 / Selinexor 40 mg/m^2 in Combination With Cytarabine and Idarubicin0
Cohort 2 / Selinexor 60 mg Flat Dose in Combination With Cytarabine and Idarubicin0

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EFS in High Risk APL Patients

EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits. (NCT02339740)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
High Risk96.1

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Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients

EFS is defined as the time from on study to failure to achieve hematological complete response (CR) prior to start of consolidation, persistence of molecular positive disease after minimal residual disease (MRD) positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits. (NCT02339740)
Timeframe: Up to 24 months

Interventionpercentage of participants (Number)
Standard Risk97.9

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Percentage of Participants Who Achieved Transfusion Conversion and Maintenance

Transfusion conversion & maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or > 4 weeks but < 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)

InterventionPercentage of participants (Number)
Baseline Independent/ Post baseline IndependentBaseline Independent/Post baseline DependentBaseline Independent/Post baseline Not EvaluableBaseline Dependent/Post baseline IndependentBaseline Dependent/Post baseline DependentBaseline Dependent/Post baseline Not Evaluable
Gilteritinib59.224.516.334.555.89.6

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Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)

CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionPercentage of participants (Number)
Gilteritinib34.0
Salvage Chemotherapy15.3

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Duration of Remission

Duration of remission included duration of composite complete remission (CRc), duration of complete remission (CR)/ complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR and duration of response (CRc + partial remission (PR). The duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse (i.e., the date of first NR after CRc or PR) for participants who achieved CRc or PR (relapse date - first CRc or PR disease assessment date + 1). Participants who died without report of relapse were considered nonevents and censored at their last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc or PR disease assessment date + 1). Other participants who did not relapse during the study were considered nonevents and censored at the last relapse-free assessment date. Duration of CR was only applicable to participants with best overall response of CR. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionMonths (Median)
Gilteritinib14.8
Salvage Chemotherapy1.8

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Duration of Overall Survival (OS)

Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive by the cutoff date. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionMonths (Median)
Gilteritinib9.3
Salvage Chemotherapy5.6

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Duration of Leukemia-Free Survival (LFS)

The LFS was defined as the time from the date of first CRc until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc (relapse date or death date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1). (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionMonths (Median)
Gilteritinib4.4
Salvage Chemotherapy6.7

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Duration of Event-Free Survival (EFS)

"EFS was defined as the time from the date of randomization until the date of documented relapse (excluding relapse after PR), treatment failure or death from any cause within 30 days after the last dose of study drug, whichever occurred first (earliest of [relapse date, treatment failure date, death date] - randomization date + 1). If a participant experienced relapse or death within 30 days after the last dose of study drug, the participant was defined as having an EFS event related to either relapse or death, and the event date was the date of relapse or death. For a participant who was not known to have had a relapse or treatment failure or death event, EFS was censored at the date of last relapse-free disease assessment (last relapse-free disease assessment date - randomization date + 1). Data was estimated based on Kaplan-Meier estimates." (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionMonths (Median)
Gilteritinib2.8
Salvage Chemotherapy0.7

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Percentage of Participants With Composite Complete Remission (CRc Rate)

CRc rate was defined as the number of participants who achieved the best response of CRc (CR,complete remission with incomplete platelet recovery (CRp) or complete remission with incomplete hematologic recovery (CRi) divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionPercentage of participants (Number)
Gilteritinib54.3
Salvage Chemotherapy21.8

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Change From Baseline in Brief Fatigue Inventory (BFI)

The Brief Fatigue Inventory (BFI) is a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions ask participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions ask participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The global BFI score will be calculated only if at least 5 of the 9 items are answered. A higher BFI fatigue score indicates worse outcome. (NCT02421939)
Timeframe: Baseline and cycle 1, day 8 and cycle 2 day 1 (up to data cut off date of 17 Sep 2018)

,
InterventionUnits on a scale (Mean)
Cycle 1 day 8 (C1D8)Cycle 2 day 1 (C2D1)
Gilteritinib-0.40.0
Salvage Chemotherapy1.00.4

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Number of Participants With Adverse Events

"A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the study drug (gilteritinib or salvage chemotherapy). If the AE occurred on day 1 and the onset check box was marked Onset after first dose of study drug or the onset check box was left blank, then the AE was considered treatment emergent. If the AE occurred on day 1 and the onset check box was marked Onset before first dose of study drug, then the AE was not considered treatment emergent. Majority of salvage chemotherapy participants finished the study by cycle 2 of treatment, the duration of exposure was longer in the gilteritinib arm compared with the salvage chemotherapy arm (126.00 [4.0, 885.0] days versus 28.0 [5.0, 217.0] days). The NCI-CTCAE is defined as National Cancer Institute-Common Terminology Criteria for Adverse Events." (NCT02421939)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)

,
InterventionParticipants (Count of Participants)
Drug-related TEAESerious TEAEDrug-related serious TEAETEAE leading to deathDrug-related TEAE leading to deathTEAE leading to withdrawal of treatmentDrug-related TEAE lead withdrawal of treatmentNCI-CTCAE Grade 3 or higher TEAEDrug-related Grade 3 or higher TEAEDeath
Gilteritinib2062058871105827236153170
Salvage Chemotherapy713416165135945781

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Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm

The CR/CRh rate was defined as the number of participants who achieved either CR or CRh at any of the postbaseline visits divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date 04 Aug 2017, the 142 patients included in the primary analysis of CR/CRh rate were followed up at least 112 days

InterventionPercentage of participants (Number)
CR/CRh rateCR rateCRh rate
Gilteritinib28.219.09.2

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Percentage of Participants With Complete Remission (CR) Rate

The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, all participants included in the primary analysis of CR rate were followed up at least 6 months

InterventionPercentage of participants (Number)
Gilteritinib21.1
Salvage Chemotherapy10.5

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Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant

Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period. (NCT02421939)
Timeframe: From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months

InterventionPercentage of participants (Number)
Gilteritinib25.5
Salvage Chemotherapy15.3

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Toxicity: Describe by the Adverse Events as Assessed by the CTCAE Grading

Describe the adverse events associated with Omacetaxine when administered in combination with cytarabine and Idarubicin as induction therapy for AML, using CTCAE grading (NCT02440568)
Timeframe: Up to 6 months after last dose of Omacetaxine

InterventionTotal Adverse Events (Number)
Patients With Newly Diagnosed AML, Cohort 147
Patients With Newly Diagnosed AML, Cohort 288
Patients With Newly Diagnosed AML, Cohort 3219
Patients With Newly Diagnosed AML, Cohort 437

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Time to Hematologic Recovery

Time to Absolute Neutrophil Count > 1.0 x 10e9/L and Platelet Count > 100 x 10e9/L, whichever was later, for those patients who achieved a remission and achieved these hematologic goals. (NCT02440568)
Timeframe: Within 6 months of last dose of Omacetaxine

InterventionDays (Median)
Patients With Newly Diagnosed AML, Cohort 125.5
Patients With Newly Diagnosed AML, Cohort 235
Patients With Newly Diagnosed AML, Cohort 333.5
Patients With Newly Diagnosed AML, Cohort 436

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Progression Free Survival

Among the participants who achieved CR,CRi, progression free survival in number of days, i.e. the number of days participants who achieved CR/CRi remained alive and in a remission. (NCT02440568)
Timeframe: 3 years

InterventionDays (Median)
Patients With Newly Diagnosed AML, Cohort 1852.5
Patients With Newly Diagnosed AML, Cohort 2100
Patients With Newly Diagnosed AML, Cohort 31241.5
Patients With Newly Diagnosed AML, Cohort 41141

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Overall Participant Survival

Observed overall survival among participants (days) (NCT02440568)
Timeframe: 3 years

InterventionDays (Median)
Patients With Newly Diagnosed AML, Cohort 1726
Patients With Newly Diagnosed AML, Cohort 2162.5
Patients With Newly Diagnosed AML, Cohort 3792.5
Patients With Newly Diagnosed AML, Cohort 433

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Optimally Tolerated Dose

"The primary endpoint is determination of the optimally active and safe dose (OD) of Omacetaxine when added to the standard-of-care induction chemotherapy for AML and estimation of the efficacy and response rate.~OD will be defined as a dose level at which fewer than 30% of patients experience hematologic toxicity and greater than 50% of patients achieve a CR (50% is an accepted CR rate in AML when using a single induction)." (NCT02440568)
Timeframe: Within 50 days (duration of hematologic recovery)

InterventionParticipants treated with OD (Number)
Patients With Newly Diagnosed AML, Cohort 10
Patients With Newly Diagnosed AML, Cohort 20
Patients With Newly Diagnosed AML, Cohort 310
Patients With Newly Diagnosed AML, Cohort 40

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Event Free Survival

Observed length of time (days) after which patients remained free of recurrence or death. (NCT02440568)
Timeframe: 6 months

InterventionDays (Median)
Patients With Newly Diagnosed AML, Cohort 166
Patients With Newly Diagnosed AML, Cohort 290.5
Patients With Newly Diagnosed AML, Cohort 365.5
Patients With Newly Diagnosed AML, Cohort 433

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Overall Survival

Overall survival was defined as the time from the start of treatment to death or date of last follow-up. (NCT02464657)
Timeframe: Up to 2 years and 10 Months

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Maximum Tolerated Dose (MTD) of Nivolumab

MTD is highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). (NCT02464657)
Timeframe: 28 days

Interventionmg/kg (Number)
Ph 1 - Nivolumab (1mg) + Idarubicin + CytarabineNA
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine3

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Event-Free Survival (EFS)

EFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. (NCT02464657)
Timeframe: 56 days

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + CytarabineNA

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Relapse Free Survival

Relapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first. (NCT02464657)
Timeframe: Up to 2 years and10 Months

InterventionMonths (Median)
Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Number of Participants With Serious Adverse Events

Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were considered to be Serious Adverse Events (SAE) if they were grade 3 or greater and deemed to be possibly, probably, or definitely related to the study treatment. (NCT02560025)
Timeframe: From the start of treatment until 30 days after the last dose of a study drug is received, up to approximately 11 months

InterventionParticipants (Count of Participants)
Alisertib / MLN823727

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Median Relapse Free Survival

"The median amount of time from achieving a complete remission to the first of disease recurrence or death. RFS applies only to the subset of patients who achieve a CR+CRi at the end of induction therapy.~Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR.~Complete remission with incomplete blood count recovery (CRi): Same as CR but without achievement of specified ANC and/or platelet count~Recurrence/ morphologic relapse: reappearance of leukemic blasts in the peripheral blood or >5% blasts in the bone marrow not attributable to any other cause" (NCT02560025)
Timeframe: From the time of treatment response until death or disease progression (up to about one year)

InterventionMonths (Median)
Alisertib / MLN8237NA

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1 Year Overall Survival Rate

The percentage of participants alive at one year (NCT02560025)
Timeframe: 1 Year

Interventionpercentage of participants (Number)
Alisertib / MLN823750

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Median Duration of Remission

"The median amount of time from first achieving remission to disease progression (with patients censored at death).~Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR.~Complete remission with incomplete blood count recovery (CRi): Same as CR but without achievement of specified ANC and/or platelet count~Recurrence/ morphologic relapse: reappearance of leukemic blasts in the peripheral blood or >5% blasts in the bone marrow not attributable to any other cause" (NCT02560025)
Timeframe: From the time of first remission to disease progression or death, median duration of 12.8 months

InterventionMonths (Median)
Alisertib / MLN823712.8

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Number of Participants That Achieved Complete Remission With Incomplete Blood Count Recovery (CRi)

"The number of participants that achieved a best overall response of CRi while on study.~Complete Remission with Incomplete Blood Count Recovery (CRi): Same as for CR but without achievement of ANC at least 1000/uL (CRi) and/or platelet count of 100,000/uL (CRp)." (NCT02560025)
Timeframe: From the start of treatment until the end of study treatment, up to approximately 10 months

InterventionParticipants (Count of Participants)
Alisertib / MLN82375

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Number of Participants That Achieved Complete Remission

"The number of participants that achieved a best overall response of complete remission while on study.~Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR." (NCT02560025)
Timeframe: From the start of treatment until the end of study treatment, up to approximately 10 months

InterventionParticipants (Count of Participants)
Alisertib / MLN823720

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Clinical Response to Crenolanib With Standard Salvage Chemotherapy

To determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but >5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. (NCT02626338)
Timeframe: 1 year

,,,
InterventionParticipants (Count of Participants)
Composite complete remission (CR+CRh+CRi)MLFSClinical benefit (CRc+PR+MLFS)
All Subjects737
Arm A: HAM Chemotherapy323
Arm B: FLAG-Ida Chemotherapy404
Arm C: MEC Chemotherapy010

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Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related. (NCT02668653)
Timeframe: Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)

,
InterventionParticipants (Count of Participants)
Any TEAEGastrointestinal disordersDiarrhoeaNauseaVomitingStomatitisConstipationAbdominal painDyspepsiaAbdominal pain upperInfections and infestationsPneumoniaSepsisGeneral disorders and administration site disordersPyrexiaOedema peripheralFatigueBlood and lymphatic system disordersFebrile neutropeniaNeutropeniaThrombocytopeniaAnaemiaMetabolism and nutrition disordersHypokalaemiaDecreased appetiteHypomagnesaemiaHypophosphataemiaHypocalcaemiaSkin and subcutaneous tissue disordersRashPruritusInvestigationsAlanine aminotransferase increasedElectrocardiogram QT prolongedAspartate aminotransferase increasedNeutrophil count decreasedRespiratory, thoracic, and mediastinal disordersCoughEpistaxisOropharyngeal painNervous system disordersHeadacheMusculoskeletal and connective tissue disordersArthralgiaBack painVascular disordersHypertensionPsychiatric disordersInsomnia
Placebo26520994845356693823251884128173109372314311327301915396363024291586640105271119121154429189753108352870335030
Quizartinib26421598906557564630292043915177112302916811754302916593463027261526935140423628271235040271037391291971295737

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Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Overall survival is defined as the time from randomization until death from any cause. (NCT02668653)
Timeframe: Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment

Interventionmonths (Median)
Quizartinib31.9
Placebo15.1

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Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Complete remission (CR) rate is defined as the percentage of participants achieving CR, defined as a disappearance of all target lesions, after Induction. (NCT02668653)
Timeframe: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)

InterventionParticipants (Count of Participants)
Quizartinib147
Placebo150

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Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Composite complete remission (CRc) rate is defined as the percentage of participants whose best response is complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle. (NCT02668653)
Timeframe: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)

InterventionParticipants (Count of Participants)
Quizartinib192
Placebo176

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Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure [TF]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: >1000 neutrophils, >100,000 platelets, <5% blasts, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation. (NCT02668653)
Timeframe: Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment

Interventionmonths (Median)
Quizartinib0.03
Placebo0.71

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Part 1 and Part 2: Gene Expression Evaluated by Disease-specific Biomarkers at Baseline

"Tumor formalin-fixed paraffin-embedded (FFPE) samples were taken to evaluate the baseline gene expression by disease-specific biomarkers such as BCL-2L1 (BCL-xl), BIRC2 (cIAP1), Caspase 3 (CASP3), STAT3, and SYK. Transcripts per million (TPM) is a normalization method for RNA-sequencing, which means for every 1,000,000 RNA molecules in the RNA-sequencing tumor FFPE sample, x came from this gene/transcript." (NCT02703272)
Timeframe: Baseline

,
InterventionTranscripts per million (Mean)
BCL-2L1 (BCL-xl)BIRC2 (cIAP1)Caspase 3 (CASP3)STAT3SYK
Part 2: Chemoimmunotherapy74.3079040.0171647.61412526.35308618.36324
Part 2: Ibrutinib+CIT (RICE or RVICI)58.0934647.2078751.14711540.02256705.29909

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Part 2: Percentage of Participants Who Achieved Complete Response (CR)

Complete response rate was defined as the percentage of participants who achieved complete response or complete response with an incomplete marrow recovery (CRi) on or prior to initiation of subsequent anti-leukemic therapy per the IRC assessment. (NCT02703272)
Timeframe: Up to 4 year and 4 months

InterventionPercentage of Participants (Number)
Part 2: Ibrutinib+CIT (RICE or RVICI)17.1
Part 2: Chemoimmunotherapy18.8

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Part 2: Overall Survival

Overall survival was defined as duration from the date of randomization to the date of the participant's death. (NCT02703272)
Timeframe: Up to 4 year and 4 months

InterventionMonths (Median)
Part 2: Ibrutinib+CIT (RICE or RVICI)14.13
Part 2: Chemoimmunotherapy11.07

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Part 2: Number of Participants With c-MYC Gene Rearrangement

Number of participants with c-MYC gene rearrangement were reported. Blood samples were taken to evaluate the levels of biomarker such as c-MYC Gene rearrangement. (NCT02703272)
Timeframe: At baseline (Cycle 1 Day 1)

InterventionParticipants (Count of Participants)
Part 2: Ibrutinib+CIT (RICE or RVICI)1
Part 2: Chemoimmunotherapy1

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Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

InterventionmL/h (Median)
12-17 years18+ years
Part 2: Ibrutinib: 329 mg/m^29821510

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Part 2: Number of Participants Who Proceeded to Stem Cell Transplantation

Number of participants who proceeded to stem cell transplantation were reported. (NCT02703272)
Timeframe: Up to end of the study (Up to 4 year and 4 months)

InterventionParticipants (Count of Participants)
Part 2: Ibrutinib+CIT (RICE or RVICI)13
Part 2: Chemoimmunotherapy7

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Part 2: Duration of Response

Duration of response was defined as the duration from date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (PD) or death, whichever occurred first. PD: >25% increase in SPD of residual lesions (calculated from nadir) on CT or MRI; Deauville score 4 or 5 on FDG-PET with increase in lesional uptake from baseline; documentation of new lesions or development of new morphologic evidence of disease in BM or CSF. (NCT02703272)
Timeframe: Up to 4 year and 4 months

InterventionMonths (Median)
Part 2: Ibrutinib+CIT (RICE or RVICI)6.01
Part 2: Chemoimmunotherapy6.51

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Part 2: Tumor Volume Reduction Rate at Day 14

The tumor volume reduction rate was defined as percent decrease in the sum of the products of the lesion diameters at Day 14. It was measured as the mean change in the sum of the products of the lesion diameters (SPD) at Day 14. (NCT02703272)
Timeframe: At Day 14

InterventionPercent change (Least Squares Mean)
Part 2: Ibrutinib+CIT (RICE or RVICI)-49.7
Part 2: Chemoimmunotherapy-58.60

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Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib

Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

,
Interventionliter(s) (Median)
1-5 years6-11 years12-17 years
Part 1: Ibrutinib: 240 mg/m^211.1183.63
Part 1: Ibrutinib: 329 mg/m^25.187.5511.3

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Part 1 and Part 2: Visual Analog Scale (VAS) Score for Palatability

Palatability of ibrutinib was measured by using a VAS. The scale is a 5-point visual analog scale incorporating a facial hedonic scale designed to span pediatric ages and levels of participant comprehension with a score range of 1 to 5, where 1 represents best score and 5 is worst palatability. (NCT02703272)
Timeframe: Day 1 of Cycle 1 and Cycle 3

,,
InterventionUnits on a scale (Mean)
Cycle 1 Day 1Cycle 3 Day 1
Part 1: Ibrutinib+RICE2.63.3
Part 1: Ibrutinib+RVICI3.22.3
Part 2: Ibrutinib+CIT (RICE or RVICI)2.42.6

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Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionmilliliter per hour (mL/h) (Median)
1-5 years6-11 years
Part 1: Ibrutinib: 440 mg/m^212001300

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Part 1: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

,
Interventionmilliliter per hour (mL/h) (Median)
1-5 years6-11 years12-17 years
Part 1: Ibrutinib: 240 mg/m^212201450348
Part 1: Ibrutinib: 329 mg/m^2508805729

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Part 1: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib

Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionliter(s) (Median)
1-5 years6-11 years
Part 1: Ibrutinib: 440 mg/m^27.6319

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Part 2: Time to Response

Time to response was defined as the time interval from the first dose of ibrutinib to the first documented response for those participants who responded. Time to response was summarized for participants who achieved either CR (including CRb and CRu) or PR. CR=disappearance of all disease; CRb=residual mass has no morphologic evidence of disease from limited or core biopsy, with no new lesions by imaging examination; BM and CSF morphologically free of disease; no new or PD elsewhere, CRu=Residual mass is negative by FDG-PET; no new lesions by imaging examination; BM and CSF morphologically free of disease; no new or PD elsewhere, PR=50% decrease in SPD on CT or MRI; FDG-PET may be positive (deauville score or 4 or 5 with reduced lesional uptake compared with baseline); no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: Up to 4 Years and 4 months

InterventionMonths (Median)
Part 2: Ibrutinib+CIT (RICE or RVICI)0.89
Part 2: Chemoimmunotherapy0.82

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Part 2: Percentage of Participants With EFS at 3 Years

EFS is the time interval from randomization to death, disease progression, or lack of complete response (CR) or partial response (PR) after 3 cycles of treatment, whichever occurs first based on blinded independent event review by the IRC. CR was defined as CT or MRI reveals no residual disease or new lesions, resected residual mass that is pathologically (morphologically) negative for disease, BM and CSF morphologically free of disease with no new lesions by imaging examination. PR was defined as 50% decrease in um of the products of the SPD on CT or MRI; FDG-PET may be positive, no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: At 3 years

InterventionPercentage of participants (Number)
Part 2: Ibrutinib+CIT (RICE or RVICI)8.6
Part 2: Chemoimmunotherapy12.5

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Part 2: Percentage of Participants With EFS at 2 Years

EFS was the time interval from randomization to death, disease progression, or lack of complete response (CR) or partial response (PR) after 3 cycles of treatment, whichever occurred first based on blinded independent event review by the IRC. CR was defined as CT or MRI reveals no residual disease or new lesions, resected residual mass that is pathologically (morphologically) negative for disease, BM and CSF morphologically free of disease with no new lesions by imaging examination. PR was defined as 50% decrease in um of the products of the SPD on CT or MRI; FDG-PET may be positive, no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: At 2 years

InterventionPercentage of participants (Number)
Part 2: Ibrutinib+CIT (RICE or RVICI)14.3
Part 2: Chemoimmunotherapy12.5

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Part 1 and Part 2: Overall Response Rate (ORR)

ORR was defined as the percentage of participants achieving a best overall response of either complete response (CR) (including CR biopsy-negative [CRb] and unconfirmed CR [CRu]) or partial response (PR) as evaluated by International Pediatric non-Hodgkin lymphoma (NHL) response criteria. CR=disappearance of all disease; CRb=residual mass has no morphologic evidence of disease from limited or core biopsy, with no new lesions by imaging examination; bone marrow (BM) and CSF morphologically free of disease; no new or PD elsewhere, CRu=Residual mass is negative by FDG-PET; no new lesions by imaging examination; BM and CSF morphologically free of disease; no new or PD elsewhere, PR=50% decrease in SPD on CT or MRI; FDG-PET may be positive (deauville score or 4 or 5 with reduced lesional uptake compared with baseline); no new or PD; morphologic evidence of disease may be present in BM or CSF if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: Up to 4 year and 4 months

InterventionPercentage of participants (Number)
Part 1: Ibrutinib+RICE81.8
Part 1: Ibrutinib+RVICI50.0
Part 2: Ibrutinib+CIT (RICE or RVICI)68.6
Part 2: Chemoimmunotherapy81.3

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Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square [mg/m^2], 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionhours*nanogram per milliliter (h*ng/mL) (Median)
1-5 years6-11 years
Part 1: Ibrutinib: 440 mg/m^2310324

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Part 1: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 milligrams per meter square [mg/m^2], 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

,
Interventionhours*nanogram per milliliter (h*ng/mL) (Median)
1-5 years6-11 years12-17 years
Part 1: Ibrutinib: 240 mg/m^21431451210
Part 1: Ibrutinib: 329 mg/m^2386349661

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Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionnanograms per milliliter (ng/mL) (Median)
1-5 years6-11 years
Part 1: Ibrutinib: 440 mg/m^25.073.88

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Part 1: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, pharmacokinetic (PK) parameters for Part 1 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

,
Interventionnanograms per milliliter (ng/mL) (Median)
1-5 years6-11 years12-17 years
Part 1: Ibrutinib: 240 mg/m^23.863.464.88
Part 1: Ibrutinib: 329 mg/m^24.483.644.73

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Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

InterventionmL/h (Median)
12-17 years
Part 2: Ibrutinib: 240 mg/m^21730

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Part 1 and Part 2: Number of Participants With Greater Than (>) 90% Bruton's Tyrosine Kinase (BTK) Occupancy

Number of participants with >90% BTK occupancy were reported. Blood samples were collected to assess BTK occupancy. (NCT02703272)
Timeframe: Up to 3 months

InterventionParticipants (Count of Participants)
Part 1: Ibrutinib5
Part 2: Ibrutinib5

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Part 2: Apparent (Oral) Plasma Clearance (CL/F) of Ibrutinib

CL/F is defined as apparent plasma clearance of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

InterventionmL/h (Median)
1-5 years6-11 years
Part 2: Ibrutinib: 440 mg/m^21110856

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Part 1 and Part 2: Number of Participants With Adverse Events as Measure of Safety and Tolerability

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. (NCT02703272)
Timeframe: Up to 4 year and 4 months

InterventionParticipants (Count of Participants)
Part 1: Ibrutinib+RICE11
Part 1: Ibrutinib+RVICI10
Part 2: Ibrutinib+CIT (RICE or RVICI)35
Part 2: Chemoimmunotherapy15

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Part 2: Percentage of Participants Who Achieved Partial Response (PR)

Percentage of participants who achieved PR were assessed. PR was defined as 50% decrease in SPD on computed tomography (CT) or magnetic resonance imaging (MRI); FDG-PET may be positive; no new or PD; morphologic evidence of disease may be present in BM or cerebrospinal fluid (CSF) if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: Up to 4 year and 4 months

Interventionpercentage of participants (Number)
Part 2: Ibrutinib+CIT (RICE or RVICI)51.4
Part 2: Chemoimmunotherapy62.5

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Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib

Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionliter(s) (Median)
1-5 years6-11 years
Part 2: Ibrutinib: 440 mg/m^21.686.18

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Part 2: Event Free Survival (EFS) Between the 2 Treatment Groups

EFS was the time interval from randomization to death, disease progression, or lack of complete response (CR) or partial response (PR) after 3 cycles of treatment, whichever occurred first based on blinded independent event review by the Independent Review Committee (IRC). CR was defined as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions, resected residual mass that was pathologically (morphologically) negative for disease, BM and CSF morphologically free of disease with no new lesions by imaging examination. PR was defined as 50 percent (%) decrease in sum of the products of the lesion diameters (SPD) on CT or MRI; fluorodeoxyglucose (FDG)-positron emission tomography (PET) may be positive, no new or progressive disease (PD); morphologic evidence of disease may be present in BM or cerebrospinal fluid (CSF) if present at diagnosis; however, there should be 50% reduction in percentage of lymphoma cells. (NCT02703272)
Timeframe: Time from Randomization to death, disease progression, or lack of CR or PR after 3 cycles of treatment (up to 4 year and 4 months)

InterventionMonths (Median)
Part 2: Ibrutinib+CIT (RICE or RVICI)6.05
Part 2: Chemoimmunotherapy6.97

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Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib

Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionliter(s) (Median)
12-17 years18+ years
Part 2: Ibrutinib: 329 mg/m^24.149.29

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Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionh*ng/mL (Mean)
12-17 years
Part 2: Ibrutinib: 240 mg/m^2:215

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Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionh*ng/mL (Mean)
1-5 years6-11 years
Part 2: Ibrutinib: 440 mg/m^2298655

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Part 2: Area Under the Plasma Concentration-time Curve (AUC) of Ibrutinib

AUC is defined as area under the plasma concentration-time curve. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionh*ng/mL (Mean)
12-17 years18+ years
Part 2: Ibrutinib: 329 mg/m^2499423

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Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionng/mL (Median)
12-17 years
Part 2: Ibrutinib: 240 mg/m^22.93

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Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionng/mL (Median)
12-17 years18+ years
Part 2: Ibrutinib: 329 mg/m^24.863.7

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Part 2: Number of Participants With CD79B, CARD11, and MYD Mutations

Number of participants with CD79B, CARD11, and MYD mutations were reported. Blood samples were taken to evaluate the levels of biomarkers such as CD79B, CARD11, and MYD mutations. (NCT02703272)
Timeframe: Up to 4 year and 4 months

,
InterventionParticipants (Count of Participants)
CD79BCARD11MYD mutation
Part 2: Chemoimmunotherapy000
Part 2: Ibrutinib+CIT (RICE or RVICI)110

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Part 2: Maximum Observed Plasma Concentration (Cmax) of Ibrutinib

Cmax is defined as maximum plasma concentration of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionng/mL (Median)
1-5 years6-11 years
Part 2: Ibrutinib: 440 mg/m^23.794.15

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Part 2: Apparent (Oral) Volume of Distribution (Vd/F) of Ibrutinib

Vd/F is defined as apparent (oral) volume of distribution of ibrutinib. As per planned analyses, PK parameters for Part 2 were presented per dose group (240 mg/m^2, 329 mg/m^2 and 440 mg/m^2) and age group (1-5, 6-11, 12-17 and >18 years). As planned in protocol, the PK parameters were presented per dose group as dosing was dependent on age. (NCT02703272)
Timeframe: Up to Cycle 3 (each cycle of 21 or 28 days)

Interventionliter(s) (Median)
12-17 years
Part 2: Ibrutinib: 240 mg/m^29.9

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Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 21 (each cycle 28 days)

,
Interventionaccumulation ratio (Geometric Mean)
Cycle 1, Day 21: Quizartinib AR (Cmax)Cycle 1, Day 21: AC886 AR (Cmax)Cycle 1, Day 21: Quizartinib + AC886 AR (Cmax)Cycle 1, Day 21: Quizartinib AR (AUCtau)Cycle 1, Day 21: AC886 AR (AUCtau)Cycle 1, Day 21: Quizartinib + AC886 AR (AUCtau)
Quizartinib 20 mg/Day1.522.652.092.373.502.99
Quizartinib 40 mg/Day1.982.552.532.843.313.24

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Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia

The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

,
Interventionng*h/mL (Geometric Mean)
Cycle 1, Day 8: Quizartinib, AUCtauCycle 1, Day 8: AC886, AUCtauCycle 1, Day 8: Quizartinib + AC886, AUCtauCycle 1, Day 21: Quizartinib, AUCtau,ssCycle 1, Day 21: AC886, AUCtau, ssCycle 1, Day 21: Quizartinib + AC886, AUCtau
Quizartinib 20 mg/Day418555101099119403020
Quizartinib 40 mg/Day92116402640294053108850

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Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia

The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1, Day 8: Quizartinib, CmaxCycle 1, Day 8: AC886, CmaxCycle 1, Day 8: Quizartinib + AC886, CmaxCycle 1, Day 21: Quizartinib, Cmax, ssCycle 1, Day 21: AC886, Cmax, ssCycle 1, Day 21: Quizartinib + AC886, Cmax
Quizartinib 20 mg/Day42.436.577.464.296.7162
Quizartinib 40 mg/Day91.3103180212256480

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Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 8 (each cycle 28 days)

,
Interventionmetabolite to parent ratio (Geometric Mean)
Cycle 1, Day 8: MR (Cmax)Cycle 1, Day 8: MR (AUCtau)
Quizartinib 20 mg/Day0.8611.33
Quizartinib 40 mg/Day1.131.78

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Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

,
Interventionhour (Median)
Cycle 1, Day 8: Quizartinib, TmaxCycle 1, Day 8: AC886, TmaxCycle 1, Day 8: Quizartinib + AC886, TmaxCycle 1, Day 21: Quizartinib, Tmax,ssCycle 1, Day 21: AC886, Tmax,ssCycle 1, Day 21: Quizartinib + AC886, Tmax
Quizartinib 20 mg/Day3.035.014.014.035.024.03
Quizartinib 40 mg/Day2.176.084.174.086.094.08

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Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 21 (each cycle 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1, Day 21: QuizartinibCycle 1, Day 21: AC886Cycle 1, Day 21: Quizartinib + AC886
Quizartinib 20 mg/Day22.768.694.6
Quizartinib 40 mg/Day77.1195299

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Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. (NCT02834390)
Timeframe: Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year

,
InterventionParticipants (Count of Participants)
Participants with TEAEsInfections and InfestationsPneumoniaSkin infectionStaphylococcal bacteraemiaBlood and Lymphatic System DisordersFebrile neutropeniaAnaemiaLeukopeniaNeutropeniaThrombocytopeniaImmune DisordersHypersensitivityMetabolism and Nutrition DisordersDecreased appetiteHypoalbuminaemiaHypokalaemiaHypomagnesaemiaHyponatraemiaHypophosphataemiaHypouricaemiaTumour lysis syndromeNervous System DisordersDysgeusiaDizzinessEye DisordersPhotophobiaCardiac DisordersPalpitationsVascular DisordersHypotensionRespiratory, Thoracic, and Mediastinal DisordersEpistaxisOropharyngeal painRespiratory disorderGastrointestinal DisordersAbdominal pain upperNauseaConstipationDiarrhoeaStomatitisCheilitisVomitingMelaenaHepatobiliary DisordersHepatic function abnormalSkin and Subcutaneous Tissue DisordersAlopeciaRashRash maculo-papularDermatitis bullousDry skinMusculoskeletal and Connective Tissue DisordersArthralgiaMusculoskeletal painMyalgiaPain in extremityRenal and Urinary DisordersHaematuriaProteinuriaUrinary tract painReproductive System and Breast DisordersMenorrhagiaGeneral Disorders & Administration Site ConditionsOedema peripheralPyrexiaInvestigationsGamma-glutamyltransferase increasedAlanine aminotransferase increasedBlood alkaline phosphatase increasedElectrocardiogram QT prolongedPlatelet count decreasedWeight decreasedWhite blood cell count decreasedAspartate aminotransferaseAspartate aminotransferase increasedBlood bilirubin increasedBlood lactate dehydrogenase increasedBlood pressure decreasedLipase increased
Quizartinib 20 mg/Day41100442111003312111012211100000000332112110004311001001011110000043210111101000
Quizartinib 40 mg/Day33111331000112110000101100011111111312221111113221113210100001111131112111010111

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Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia

Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. (NCT02834390)
Timeframe: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year

,
Interventionpercentage of participants (Number)
Composite CR rate (CRc rate: CR+CRp+CRi)Response rate (CRc+PR)
Quizartinib 20 mg/Day75.0100
Quizartinib 40 mg/Day66.766.7

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Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. (NCT02834390)
Timeframe: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year

,
InterventionParticipants (Count of Participants)
Complete remission (CR)CR with incomplete platelet recovery (CRp)CR with incomplete hematological recovery (CRi)Partial remission (PR)No response (NR)
Quizartinib 20 mg/Day00310
Quizartinib 40 mg/Day00201

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Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier. (NCT02834390)
Timeframe: Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year

,
InterventionParticipants (Count of Participants)
Participants with TEAEsInfections and InfestationsLung infectionSkin infectionUpper respiratory tract infectionBlood and Lymphatic System DisordersFebrile neutropeniaNervous System DisordersDysgeusiaGastrointestinal DisordersDiarrhoeaNauseaStomatitisSkin and Subcutaneous Tissue DisordersRashRash maculo-papularGeneral Disorders & Administration Site ConditionsOedema peripheralInvestigationsPlatelet count decreasedWhite blood cell count decreasedAlanine aminotransferase increasedElectrocardiogram QT prolongedInjury, Poisoning, and Procedural ComplicationsContusionFall
Quizartinib 20 mg/Day21011221122111101121110000
Quizartinib 40 mg/Day11100110000001010011101111

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Time to Platelet Recovery

Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL) (NCT02873338)
Timeframe: Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle

,,
Interventiondays (Median)
Recovery to >20,000µLRecovery to >100,000µL
Control (Idarubicin+Cytarabine)3538
Dociparstat 0.125 mg/kg3650
Dociparstat 0.25 mg/kg2932

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Number of Subjects Who Died by Day 60.

Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. (NCT02873338)
Timeframe: 60 days (from the first day of induction treatment to 60 days after)

InterventionParticipants (Count of Participants)
Control (Idarubicin+Cytarabine)2
Dociparstat 0.125 mg/kg2
Dociparstat 0.25 mg/kg3

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Number of Subjects Who Died by Day 30

Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. (NCT02873338)
Timeframe: 30 days (from first day of induction treatment to 30 days after)

InterventionParticipants (Count of Participants)
Control (Idarubicin+Cytarabine)2
Dociparstat 0.125 mg/kg1
Dociparstat 0.25 mg/kg3

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Number of Subjects Who Achieved Composite Complete Remission

The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) >1000/μL, platelet count >100,000/μL, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC <1000/μL and/or platelet count <100,000/, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. (NCT02873338)
Timeframe: Up to 60 days after the start of each treatment cycle

InterventionParticipants (Count of Participants)
Control (Idarubicin+Cytarabine)16
Dociparstat 0.125 mg/kg9
Dociparstat 0.25 mg/kg15

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Duration of Morphologic Complete Remission

"The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, >5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of >5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of >5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first.~Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)" (NCT02873338)
Timeframe: Randomization to end of study (18 months)

Interventiondays (Median)
Control (Idarubicin+Cytarabine)233
Dociparstat 0.125 mg/kg494
Dociparstat 0.25 mg/kg294

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Duration of Event-free Survival

Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. (NCT02873338)
Timeframe: Randomization up to 30 months

Interventiondays (Median)
Control (Idarubicin+Cytarabine)243.5
Dociparstat 0.125 mg/kg1
Dociparstat 0.25 mg/kg171.5

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Number of Subjects Who Achieved Morphologic Complete Remission

Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. (NCT02873338)
Timeframe: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)

InterventionParticipants (Count of Participants)
Control (Idarubicin+Cytarabine)14
Dociparstat 0.125 mg/kg8
Dociparstat 0.25 mg/kg11

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Time to Recovery of Neutrophils

Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC >500/µL and >1000/µL) for up to 60 days after the start of each treatment cycle. (NCT02873338)
Timeframe: Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle

,,
Interventiondays (Median)
Recovery to >500/µLRecovery to >1000/µL
Control (Idarubicin+Cytarabine)3237
Dociparstat 0.125 mg/kg4342
Dociparstat 0.25 mg/kg2935

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Time to Leukemia-free Survival

Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. (NCT02873338)
Timeframe: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months

Interventiondays (Median)
Control (Idarubicin+Cytarabine)292
Dociparstat 0.125 mg/kg448
Dociparstat 0.25 mg/kg166

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Number of Subjects Who Died by Day 90

Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. (NCT02873338)
Timeframe: 90 days (from the first day of induction treatment to 90 days after)

InterventionParticipants (Count of Participants)
Control (Idarubicin+Cytarabine)2
Dociparstat 0.125 mg/kg3
Dociparstat 0.25 mg/kg3

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Number of Participants With Infusion Reactions (IRs)

An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator. (NCT03860844)
Timeframe: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)

InterventionParticipants (Count of Participants)
B-cell Acute Lymphoblastic Leukemia (B-ALL)9
T-cell Acute Lymphoblastic Leukemia (T-ALL)5
Acute Myeloid Leukemia (AML)15

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Overall Response Rate (ORR)

ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site. (NCT03860844)
Timeframe: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks

Interventionpercentage of participants (Number)
B-cell Acute Lymphoblastic Leukemia (B-ALL)52.0
T-cell Acute Lymphoblastic Leukemia (T-ALL)54.5
Acute Myeloid Leukemia (AML)65.2

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Percentage of Participants With Complete Response (CR) Rate

The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). (NCT03860844)
Timeframe: From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks

Interventionpercentage of participants (Number)
B-cell Acute Lymphoblastic Leukemia (B-ALL)52.0
T-cell Acute Lymphoblastic Leukemia (T-ALL)45.5
Acute Myeloid Leukemia (AML)60.9

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AML: Ceoi of Isatuximab

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT03860844)
Timeframe: At end of infusion on Cycle 1 Days 1 and 15

Interventionmcg/mL (Mean)
Cycle 1: Day 1Cycle 1: Day 15
Acute Myeloid Leukemia (AML)363562

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first. (NCT03860844)
Timeframe: From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)

,,
InterventionParticipants (Count of Participants)
Any TEAEAny TESAE
Acute Myeloid Leukemia (AML)2616
B-cell Acute Lymphoblastic Leukemia (B-ALL)2719
T-cell Acute Lymphoblastic Leukemia (T-ALL)1312

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Cluster of Differentiation (CD)38 Receptor Density

"Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where a was the slope and b was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control." (NCT03860844)
Timeframe: Pre-dose on Day 1

,,
InterventionsABC (Mean)
Blood blast cells: CR/CRiBlood blast cells: Non CR/CRi;Blood immune cells (Natural Killer [NK] cells): CR/CRiBlood immune cells (NK cells): Non CR/CRi
Acute Myeloid Leukemia (AML)19502.09815.011220.322530.0
B-cell Acute Lymphoblastic Leukemia (B-ALL)20345.631080.013506.216650.0
T-cell Acute Lymphoblastic Leukemia (T-ALL)12780.022952.022639.033859.0

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CD38 Receptor Occupancy

Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. (NCT03860844)
Timeframe: Pre-dose on Day 15

Interventionpercent receptor occupancy (Mean)
Blood plasma cells: CR/CRiBlood plasma cells: Non CR/CRi;Blood NK cells: CR/CRiBlood NK cells: Non CR/CRi
T-cell Acute Lymphoblastic Leukemia (T-ALL)40.555.066.770.0

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AML: AUC of Isatuximab

Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. (NCT03860844)
Timeframe: From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8

Interventionmg*h/L (Mean)
Week 0 to Week 1Week 0 to Week 3Week 0 to Week 8
Acute Myeloid Leukemia (AML)28592130862291962

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B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT03860844)
Timeframe: At end of infusion on Cycle 1 Days 1 and 29

,
Interventionmcg/mL (Mean)
Cycle 1: Day 1Cycle 1: Day 29
B-cell Acute Lymphoblastic Leukemia (B-ALL)452835
T-cell Acute Lymphoblastic Leukemia (T-ALL)259745

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B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab

Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. (NCT03860844)
Timeframe: From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10

,
Interventionmg*hour (h)/Liter (L) (Mean)
Week 0 to Week 1Week 0 to Week 5Week 0 to Week 10
B-cell Acute Lymphoblastic Leukemia (B-ALL)31703299071582686
T-cell Acute Lymphoblastic Leukemia (T-ALL)29057289167540375

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CD38 Receptor Occupancy

Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. (NCT03860844)
Timeframe: Pre-dose on Day 15

Interventionpercent receptor occupancy (Mean)
Blood plasma cells: Non CR/CRi;Blood NK cells: CR/CRiBlood NK cells: Non CR/CRi
B-cell Acute Lymphoblastic Leukemia (B-ALL)44.055.661.3

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