Page last updated: 2024-11-05

thalidomide and Chromosomal Triplication

thalidomide has been researched along with Chromosomal Triplication in 19 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research Excerpts

ExcerptRelevanceReference
"Prognostic impact of specific chromosomal aberrations in patients with relapsed multiple myeloma (MM) treated with the novel agents is briefly described."5.39Gain(1)(q21) is an unfavorable genetic prognostic factor for patients with relapsed multiple myeloma treated with thalidomide but not for those treated with bortezomib. ( Adam, Z; Almasi, M; Berankova, K; Frohlich, J; Greslikova, H; Hajek, R; Jarkovsky, J; Jurczyszyn, A; Kaisarova, P; Krejci, M; Kuglik, P; Kupska, R; Melicharova, H; Mikulasova, A; Nemec, P; Penka, M; Sandecka, V; Sevcikova, S; Smetana, J; Zahradova, L; Zaoralova, R, 2013)
"Lenalidomide is a candidate for study in AML based on its clinical activity in a related disorder, myelodysplastic syndrome (MDS), with the 5q- chromosomal abnormality."2.74Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13. ( Abboud, CN; Blum, W; Byrd, JC; Fehniger, TA; Kefauver, C; Marcucci, G; Payton, JE; Vij, R, 2009)
"MDS with trisomy 8 has been observed in adult patients with Behçet syndrome with some cases developing prior to the clinical manifestations of the latter."2.44Myelodysplastic syndrome with trisomy 8 associated with Behçet syndrome: an immunologic link to a karyotypic abnormality. ( Bolton-Maggs, P; Field, A; Moots, R; Salim, R; Thachil, JV, 2008)
"Treatment benefit in multiple myeloma (MM) patients with high-risk cytogenetics remains suboptimal."1.62Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. ( Alegre, A; Campana, F; Delimpasi, S; Facon, T; Harrison, SJ; Hulin, C; Inchauspé, M; Macé, S; Perrot, A; Richardson, P; Risse, ML; Simpson, D; Spencer, A; Sunami, K; van de Velde, H; Vlummens, P; Wang, MC; Yong, K, 2021)
"Prognostic impact of specific chromosomal aberrations in patients with relapsed multiple myeloma (MM) treated with the novel agents is briefly described."1.39Gain(1)(q21) is an unfavorable genetic prognostic factor for patients with relapsed multiple myeloma treated with thalidomide but not for those treated with bortezomib. ( Adam, Z; Almasi, M; Berankova, K; Frohlich, J; Greslikova, H; Hajek, R; Jarkovsky, J; Jurczyszyn, A; Kaisarova, P; Krejci, M; Kuglik, P; Kupska, R; Melicharova, H; Mikulasova, A; Nemec, P; Penka, M; Sandecka, V; Sevcikova, S; Smetana, J; Zahradova, L; Zaoralova, R, 2013)

Research

Studies (19)

TimeframeStudies, this research(%)All Research%
pre-199010 (52.63)18.7374
1990's0 (0.00)18.2507
2000's3 (15.79)29.6817
2010's3 (15.79)24.3611
2020's3 (15.79)2.80

Authors

AuthorsStudies
Sakai, H1
Miura, I1
Arai, A1
Wei, Q1
Zhang, X1
Peng, Y1
Chen, K1
Xu, S1
Huang, X1
Zhang, L1
Xie, Q1
He, Y1
Li, Y1
Chai, J1
Harrison, SJ1
Perrot, A1
Alegre, A1
Simpson, D1
Wang, MC1
Spencer, A1
Delimpasi, S1
Hulin, C1
Sunami, K1
Facon, T1
Vlummens, P1
Yong, K1
Campana, F1
Inchauspé, M1
Macé, S1
Risse, ML1
van de Velde, H1
Richardson, P1
Mangiacavalli, S1
Pochintesta, L1
Cocito, F1
Pompa, A1
Bernasconi, P1
Cazzola, M1
Corso, A1
Fehniger, TA1
Byrd, JC1
Marcucci, G1
Abboud, CN1
Kefauver, C1
Payton, JE1
Vij, R1
Blum, W1
Mesa, RA1
Hanson, CA1
Ketterling, RP1
Schwager, S1
Knudson, RA1
Tefferi, A1
Coutinho, R1
Costa, D1
Carrió, A1
Muñoz, C1
Vidal, A1
Belkaid, M1
Campo, E1
Nomdedeu, B1
Smetana, J1
Berankova, K1
Zaoralova, R1
Nemec, P1
Greslikova, H1
Kupska, R1
Mikulasova, A1
Frohlich, J1
Sevcikova, S1
Zahradova, L1
Krejci, M1
Sandecka, V1
Almasi, M1
Kaisarova, P1
Melicharova, H1
Adam, Z1
Penka, M1
Jarkovsky, J1
Jurczyszyn, A1
Hajek, R1
Kuglik, P1
ZELLWEGER, H1
HUFF, DS1
ABBO, G1
Thachil, JV1
Salim, R1
Field, A1
Moots, R1
Bolton-Maggs, P1
Jörgensen, G3
Shiono, H1
Holt, SB1
Kernis, MM1
Terrahe, K1
Schönenberg, H1
Poznanski, AK1
Garn, SM1
Holt, JF1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.[NCT00466895]Phase 137 participants (Actual)Interventional2007-04-30Completed
Phase II Trial of Lenalidomide in Older Patients (>/= 60 Years) With Untreated Acute Myeloid Leukemia Without Chromosome 5q Abnormalities[NCT00546897]Phase 248 participants (Actual)Interventional2007-02-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

CR With Complete Blood Counts (CRi) Rate

CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 10
Cohort 24

Cytogenetics CR Rate (CRc)

Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells). (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 11
Cohort 23

Duration of CR for Complete Responders

Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 210

Morphologic Complete Remission Rate (CRm)

CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 10
Cohort 23

Morphologic Leukemia Free State

Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 11
Cohort 210

Overall Survival (OS)

Overall survival: Defined as the date of first dose of study drug to the date of death from any cause. (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 24

Partial Remission Rate (PR)

Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission. (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

Interventionparticipants (Number)
Cohort 11
Cohort 20

Progression-free Survival

Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is. (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 22

Relapse Free Survival (RFS) for Complete Responders

This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause. (NCT00546897)
Timeframe: 2 years

Interventionmonths (Median)
Cohort 210

Safety and Tolerability (Removal From Study Due to Adverse Events)

Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting (NCT00546897)
Timeframe: 4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]

Interventionparticipants (Number)
Cohort 11
Cohort 28

Complete Remission Rate (CRm + CRi + CRc)

"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)." (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

,
Interventionparticipants (Number)
CRmCRiCRc
Cohort 1001
Cohort 2343

Response Rate (RR)

"RR = as patients obtaining any response (CRm + CRc +CRi + PR).~CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Partial remission (PR): Requires" (NCT00546897)
Timeframe: After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)

,
Interventionparticipants (Number)
CRmCRcCRiPR
Cohort 10101
Cohort 23340

Reviews

4 reviews available for thalidomide and Chromosomal Triplication

ArticleYear
Myelodysplastic syndrome with trisomy 8 associated with Behçet syndrome: an immunologic link to a karyotypic abnormality.
    Pediatric blood & cancer, 2008, Volume: 50, Issue:3

    Topics: Adolescent; Anemia, Refractory; Behcet Syndrome; Chromosomes, Human, Pair 8; Female; Humans; Immunol

2008
[Human genetic aspects of inborn ear, nose, and throat diseases].
    HNO, 1985, Volume: 33, Issue:6

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acrocephalosyndactylia; Child, Preschool; Chro

1985
[Diseases and dermatoglyphics].
    Nihon hoigaku zasshi = The Japanese journal of legal medicine, 1970, Volume: 24, Issue:6

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Bone and Bones; Chromosome Aberrations; Chromo

1970
Principles of teratology.
    Obstetrics and gynecology annual, 1972, Volume: 1, Issue:0

    Topics: Abnormalities, Drug-Induced; Amniocentesis; Animals; Chromosome Aberrations; Chromosome Disorders; C

1972

Trials

1 trial available for thalidomide and Chromosomal Triplication

ArticleYear
Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13.
    Blood, 2009, Jan-29, Volume: 113, Issue:5

    Topics: Aged; Antineoplastic Agents; Chromosomes, Human, Pair 13; Humans; Lenalidomide; Leukemia, Myeloid, A

2009
Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13.
    Blood, 2009, Jan-29, Volume: 113, Issue:5

    Topics: Aged; Antineoplastic Agents; Chromosomes, Human, Pair 13; Humans; Lenalidomide; Leukemia, Myeloid, A

2009
Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13.
    Blood, 2009, Jan-29, Volume: 113, Issue:5

    Topics: Aged; Antineoplastic Agents; Chromosomes, Human, Pair 13; Humans; Lenalidomide; Leukemia, Myeloid, A

2009
Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13.
    Blood, 2009, Jan-29, Volume: 113, Issue:5

    Topics: Aged; Antineoplastic Agents; Chromosomes, Human, Pair 13; Humans; Lenalidomide; Leukemia, Myeloid, A

2009

Other Studies

14 other studies available for thalidomide and Chromosomal Triplication

ArticleYear
Quantitative evaluation of treatment response to lenalidomide by applying fluorescence in situ hybridization for peripheral blood granulocytes in a patient with 5q- syndrome.
    Journal of clinical and experimental hematopathology : JCEH, 2022, Sep-28, Volume: 62, Issue:3

    Topics: Aged, 80 and over; Anemia, Macrocytic; Chromosome Deletion; Chromosomes, Human, Pair 5; Cri-du-Chat

2022
Successful treatment by thalidomide therapy of intestinal Behçet's disease associated with trisomy 8 myelodysplastic syndrome.
    Rheumatology (Oxford, England), 2021, 06-18, Volume: 60, Issue:6

    Topics: Behcet Syndrome; Chromosomes, Human, Pair 8; Female; Humans; Immunosuppressive Agents; Intestinal Di

2021
Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics.
    British journal of haematology, 2021, Volume: 194, Issue:1

    Topics: Abnormal Karyotype; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplasti

2021
Correlation between burden of 17P13.1 alteration and rapid escape to plasma cell leukaemia in multiple myeloma.
    British journal of haematology, 2013, Volume: 162, Issue:4

    Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Bortezomib; Chromosomes, Human,

2013
Trisomy 13: prevalence and clinicopathologic correlates of another potentially lenalidomide-sensitive cytogenetic abnormality.
    Blood, 2009, Jan-29, Volume: 113, Issue:5

    Topics: Antineoplastic Agents; Chromosomes, Human, Pair 13; Female; Humans; Lenalidomide; Leukemia, Myeloid,

2009
Response to lenalidomide in patients with myelodysplastic syndrome with deletion 5q: clinical and cytogenetic analysis of a single centre series.
    Annals of hematology, 2010, Volume: 89, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Chromosome Deletion; Clinical Trials as Topic

2010
Gain(1)(q21) is an unfavorable genetic prognostic factor for patients with relapsed multiple myeloma treated with thalidomide but not for those treated with bortezomib.
    Clinical lymphoma, myeloma & leukemia, 2013, Volume: 13, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Boronic Acids; Bortezomib; Chromosome Aberrat

2013
PHOCOMELIA AND TRISOMY E.
    Acta geneticae medicae et gemellologiae, 1965, Volume: 14

    Topics: Classification; Diagnosis; Ectromelia; Infant, Newborn; Thalidomide; Toxicology; Trisomy

1965
[Abnormalities in the field of otorhinolaryngology. Genetic report].
    Archiv fur klinische und experimentelle Ohren- Nasen- und Kehlkopfheilkunde, 1972, Volume: 202, Issue:1

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acrocephalosyndactylia; Chromosome Aberrations

1972
[Malformations in otorhinolaryngology. Genetic report].
    Archiv fur klinische und experimentelle Ohren- Nasen- und Kehlkopfheilkunde, 1972, Volume: 202, Issue:2

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Child; Chromosome Aberrations; Chromosome Diso

1972
The significance of dermatoglyphics in medicine. A short survey and summary.
    Clinical pediatrics, 1973, Volume: 12, Issue:8

    Topics: Abnormalities, Drug-Induced; Chromosome Aberrations; Chromosome Disorders; Chromosomes, Human, 13-15

1973
[Diagnosis of malformations of the ear and temporal bone].
    Archiv fur klinische und experimentelle Ohren- Nasen- und Kehlkopfheilkunde, 1972, Volume: 202, Issue:1

    Topics: Abducens Nerve; Abnormalities, Drug-Induced; Abnormalities, Multiple; Audiometry; Craniofacial Dysos

1972
[Malformation syndrome and urinary organs].
    Zeitschrift fur Urologie und Nephrologie, 1971, Volume: 64, Issue:1

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Child; Child, Preschool; Chromosomes, Human, 1

1971
The thumb in the congenital malformation syndromes.
    Radiology, 1971, Volume: 100, Issue:1

    Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Acrocephalosyndactylia; Anemia, Aplastic; Arm;

1971