adenine has been researched along with Infections in 20 studies
Infections: Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases.
Excerpt | Relevance | Reference |
---|---|---|
"Moving from the recognition that infection control represents an unmet need, the Italian Society of Hematology (SIE) convened a panel of experts who had published and/or expressed an interest in infection complications in CLL." | 6.61 | Infection control in patients treated for chronic lymphocytic leukemia with ibrutinib or idelalisib: recommendations from Italian society of hematology. ( Barosi, G; Gaidano, G; Girmenia, C; Marchetti, M; Pane, F; Rambaldi, A; Tura, S; Zinzani, PL, 2019) |
" Limited data have been published about the infection risk associated with these new drugs, therefore this study analyzes the infectious complications in patients with lymphoproliferative diseases (LPD) treated with monoclonal antibodies (obinutuzumab, ofatumumab, brentuximab, nivolumab, or pembrolizumab), BTK inhibitors (ibrutinib and acalabrutinib), PI3K inhibitors (idelalisib) and BCL2 inhibitors (venetoclax)." | 4.02 | Severe infections in patients with lymphoproliferative diseases treated with new targeted drugs: A multicentric real-world study. ( Alonso, C; Ángel Hernández-Rivas, J; Bastidas, G; Bastos-Oreiro, M; Bocanegra, A; Carpio, C; Comai, A; Cordoba, R; De Nicolás, R; Del Campo, R; Fernández-Cruz, A; García-Suárez, J; Grande, C; Jiménez-Ubieto, A; López-Guillermo, A; López-Jiménez, J; Luis Plana, J; Marquet, J; Martín, X; Martínez-López, J; Mas-Ochoa, C; Morillo, D; Navarro-Matilla, B; Núñez, L; Prat, M; Romero, S; Ruiz-Camps, I; Seri, C; Serna, Á; Stefania Infante, M; Vásquez, L; Villafuerte, P, 2021) |
"Ibrutinib has superior progression-free survival compared with bendamustine plus rituximab (BR) in older CLL patients, however, differences in treatment duration, six monthly BR cycles versus continuous ibrutinib, complicate adverse event (AE) comparisons." | 3.01 | Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202. ( Abramson, JS; Bartlett, NL; Booth, AM; Brander, DM; Brown, JR; Byrd, JC; Coutre, S; Ding, W; Erba, H; Kuzma, CS; Larson, RA; Little, RF; Litzow, M; Mandrekar, SJ; Nattam, S; Owen, C; Ruppert, AS; Smith, SE; Stone, RM; Woyach, JA, 2021) |
" In the integrated analysis (ibrutinib treatment up to 43 months), the most common adverse events (AEs) were primarily grade 1/2; diarrhea (n = 173, 52% any-grade; n = 15, 5% grade 3) and fatigue (n = 119, 36% any-grade; n = 10, 3% grade 3)." | 2.90 | Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. ( Barr, PM; Barrientos, JC; Burger, JA; Byrd, JC; Chang, S; Coutre, SE; Dean, JP; Devereux, S; Furman, RR; Ghia, P; Hillmen, P; James, DF; Kipps, TJ; Moreno, C; O'Brien, SM; O'Dwyer, M; Robak, T; Schuh, A; Valentino, R, 2019) |
"Whether this affects infection susceptibility and vaccination efficacy requires further investigation." | 2.72 | BTK Inhibitors in Chronic Lymphocytic Leukemia: Biological Activity and Immune Effects. ( Mulder, TA; Österborg, A; Palma, M, 2021) |
"Moving from the recognition that infection control represents an unmet need, the Italian Society of Hematology (SIE) convened a panel of experts who had published and/or expressed an interest in infection complications in CLL." | 2.61 | Infection control in patients treated for chronic lymphocytic leukemia with ibrutinib or idelalisib: recommendations from Italian society of hematology. ( Barosi, G; Gaidano, G; Girmenia, C; Marchetti, M; Pane, F; Rambaldi, A; Tura, S; Zinzani, PL, 2019) |
"Increased infections have been observed in patients taking ibrutinib." | 2.58 | Systematic review of infectious events with the Bruton tyrosine kinase inhibitor ibrutinib in the treatment of hematologic malignancies. ( Pauff, JM; Satyanarayana, G; Talbott, M; Tillman, BF; Warner, JL, 2018) |
"While opportunistic infections and viral reactivations occur with both ibrutinib and idelalisib, these complications are less common and less severe with ibrutinib, especially when used as monotherapy without additional immunosuppressive agents." | 2.58 | Immunological changes with kinase inhibitor therapy for chronic lymphocytic leukemia. ( Pleyer, C; Sun, C; Wiestner, A, 2018) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (5.00) | 29.6817 |
2010's | 12 (60.00) | 24.3611 |
2020's | 7 (35.00) | 2.80 |
Authors | Studies |
---|---|
Stefania Infante, M | 1 |
Fernández-Cruz, A | 1 |
Núñez, L | 1 |
Carpio, C | 1 |
Jiménez-Ubieto, A | 1 |
López-Jiménez, J | 1 |
Vásquez, L | 1 |
Del Campo, R | 1 |
Romero, S | 1 |
Alonso, C | 1 |
Morillo, D | 1 |
Prat, M | 1 |
Luis Plana, J | 1 |
Villafuerte, P | 1 |
Bastidas, G | 1 |
Bocanegra, A | 1 |
Serna, Á | 1 |
De Nicolás, R | 1 |
Marquet, J | 1 |
Mas-Ochoa, C | 1 |
Cordoba, R | 1 |
García-Suárez, J | 1 |
Comai, A | 1 |
Martín, X | 1 |
Bastos-Oreiro, M | 1 |
Seri, C | 1 |
Navarro-Matilla, B | 1 |
López-Guillermo, A | 1 |
Martínez-López, J | 1 |
Ángel Hernández-Rivas, J | 1 |
Ruiz-Camps, I | 2 |
Grande, C | 1 |
Munir, T | 1 |
Brown, JR | 2 |
O'Brien, S | 1 |
Barrientos, JC | 2 |
Barr, PM | 2 |
Reddy, NM | 1 |
Coutre, S | 2 |
Tam, CS | 1 |
Mulligan, SP | 1 |
Jaeger, U | 1 |
Kipps, TJ | 2 |
Moreno, C | 3 |
Montillo, M | 1 |
Burger, JA | 2 |
Byrd, JC | 4 |
Hillmen, P | 3 |
Dai, S | 1 |
Szoke, A | 1 |
Dean, JP | 2 |
Woyach, JA | 2 |
Los-Arcos, I | 1 |
Aguilar-Company, J | 1 |
Hardy-Abeloos, C | 1 |
Pinotti, R | 1 |
Gabrilove, J | 1 |
Cassin, R | 1 |
Visentin, A | 1 |
Giannarelli, D | 1 |
Noto, A | 1 |
Mauro, FR | 1 |
Baldini, L | 1 |
Trentin, L | 1 |
Reda, G | 1 |
Lipsky, A | 2 |
Lamanna, N | 1 |
Ruppert, AS | 1 |
Booth, AM | 1 |
Ding, W | 1 |
Bartlett, NL | 1 |
Brander, DM | 1 |
Nattam, S | 1 |
Larson, RA | 1 |
Erba, H | 1 |
Litzow, M | 1 |
Owen, C | 1 |
Kuzma, CS | 1 |
Abramson, JS | 1 |
Little, RF | 1 |
Smith, SE | 1 |
Stone, RM | 1 |
Mandrekar, SJ | 1 |
Palma, M | 1 |
Mulder, TA | 1 |
Österborg, A | 1 |
Tillman, BF | 1 |
Pauff, JM | 1 |
Satyanarayana, G | 1 |
Talbott, M | 1 |
Warner, JL | 1 |
Gribben, JG | 1 |
Bosch, F | 1 |
Cymbalista, F | 2 |
Geisler, CH | 1 |
Ghia, P | 2 |
Stilgenbauer, S | 1 |
Awan, FT | 1 |
Jurczak, W | 1 |
Pleyer, C | 1 |
Wiestner, A | 2 |
Sun, C | 2 |
Ball, S | 1 |
Vutthikraivit, W | 1 |
Maiti, A | 1 |
Short, NJ | 1 |
Stephens, DM | 1 |
Autore, F | 1 |
Innocenti, I | 1 |
Morelli, F | 1 |
Sorà, F | 1 |
Corbingi, A | 1 |
Fianchi, L | 1 |
Criscuolo, M | 1 |
Pagano, L | 1 |
Sica, S | 1 |
Laurenti, L | 1 |
Zinzani, PL | 1 |
Rambaldi, A | 1 |
Gaidano, G | 1 |
Girmenia, C | 1 |
Marchetti, M | 1 |
Pane, F | 1 |
Tura, S | 1 |
Barosi, G | 1 |
Coutre, SE | 1 |
Devereux, S | 1 |
Robak, T | 1 |
Schuh, A | 1 |
Furman, RR | 1 |
O'Dwyer, M | 1 |
Valentino, R | 1 |
Chang, S | 1 |
James, DF | 1 |
O'Brien, SM | 1 |
Tian, X | 1 |
Lee, YS | 1 |
Gunti, S | 1 |
Herman, SE | 1 |
Salem, D | 1 |
Stetler-Stevenson, M | 1 |
Yuan, C | 1 |
Kardava, L | 1 |
Moir, S | 1 |
Maric, I | 1 |
Valdez, J | 1 |
Soto, S | 1 |
Marti, GE | 1 |
Farooqui, MZ | 1 |
Notkins, AL | 1 |
Aue, G | 1 |
Michallet, AS | 1 |
Campidelli, A | 1 |
Lequeu, H | 1 |
Dilhuydy, MS | 1 |
Tournilhac, O | 1 |
Fornecker, LM | 1 |
Dupuis, J | 1 |
De Guibert, S | 1 |
Delmer, A | 1 |
Vilque, JP | 1 |
Ghez, D | 1 |
Leblond, V | 1 |
Subtil, F | 1 |
Feugier, P | 1 |
Ysebaert, L | 1 |
Nakagawa, J | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors[NCT05643235] | 50 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting | |||
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma[NCT01578707] | Phase 3 | 391 participants (Actual) | Interventional | 2012-06-30 | Completed | ||
A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)[NCT01886872] | Phase 3 | 547 participants (Actual) | Interventional | 2013-12-09 | Active, not recruiting | ||
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia[NCT01109069] | Phase 2 | 199 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia[NCT01105247] | Phase 1/Phase 2 | 133 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)[NCT01724346] | Phase 3 | 232 participants (Actual) | Interventional | 2012-08-28 | Completed | ||
Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma[NCT01722487] | Phase 3 | 269 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
A Phase II Study of PCI-32765 for Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Need Therapy and Are Older Than 65 or Have a 17p Deletion[NCT01500733] | Phase 2 | 86 participants (Actual) | Interventional | 2012-01-05 | Active, not recruiting | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm (NCT01578707)
Timeframe: OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 65.1 |
Ibrutinib (Arm B) | 67.7 |
Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013 (NCT01578707)
Timeframe: About 18 months after the first subject was enrolled
Intervention | percentage of participants (Number) |
---|---|
Ofatumumab (Arm A) | 4.1 |
Ibrutinib (Arm B) | 42.6 |
Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | percentage of participants (Number) |
---|---|
Ofatumumab (Arm A) | 22.4 |
Ibrutinib (Arm B) | 87.7 |
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines. (NCT01578707)
Timeframe: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 8.1 |
Ibrutinib (Arm B) | NA |
Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 8.1 |
Ibrutinib (Arm B) | 44.1 |
Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors. (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | percentage of participants (Number) | |
---|---|---|
Hgb Improvement in patient with baseline anemia | Platelet improvement in baseline thrombocytopenia | |
Ibrutinib (Arm B) | 69.7 | 78.4 |
Ofatumumab (Arm A) | 32.6 | 9.4 |
The Kaplan-Meier method will be used to estimate median DOR. DOR is the time from first objective status to progression or death. CR requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. PR requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL). (NCT01886872)
Timeframe: From the date of first response until progression or death, performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | months (Median) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 50 |
Arm B (Ibrutinib) | NA |
Arm C (Ibrutinib, Rituximab) | NA |
The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm. OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. (NCT01886872)
Timeframe: From the date of registration to the date of death, assessed up to 2 years
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 95 |
Arm B (Ibrutinib) | 90 |
Arm C (Ibrutinib, Rituximab) | 94 |
Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. Complete response rate and corresponding exact binomial 95% confidence intervals provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 26 |
Arm B (Ibrutinib) | 7 |
Arm C (Ibrutinib, Rituximab) | 12 |
Complete response (CR) requires all of the following: absence of lymphadenopathy >1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. Partial response (PR) requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).Overall response rate and corresponding exact binomial 95% CI provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled;up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 75 |
Arm B (Ibrutinib) | 93 |
Arm C (Ibrutinib, Rituximab) | 94 |
Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). Response rate and corresponding exact binomial 95% confidence intervals provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 33 |
Arm B (Ibrutinib) | 10 |
Arm C (Ibrutinib, Rituximab) | 23 |
Estimated using the number of patients who achieve minimal residual disease divided by the total number randomized to that treatment arm. Corresponding exact binomial 95% confidence intervals for MRD rates will be calculated. (NCT01886872)
Timeframe: Cycle 9 Day 1 Evaluation
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 8 |
Arm B (Ibrutinib) | 1 |
Arm C (Ibrutinib, Rituximab) | 4 |
The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50% with >= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first. (NCT01886872)
Timeframe: Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.
Intervention | months (Median) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 43 |
Arm B (Ibrutinib) | NA |
Arm C (Ibrutinib, Rituximab) | NA |
The Kaplan-Meier method will be used to estimate the rate of progression free survival at 2 years in each treatment arm. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50%, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first. (NCT01886872)
Timeframe: Time from study entry to the time of documented disease progression or death, assessed up to 2 years
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 74 |
Arm B (Ibrutinib) | 87 |
Arm C (Ibrutinib, Rituximab) | 88 |
The rate of grade 3, 4, or 5 treatment-related non-hematologic adverse events (toxicities) by arm; excludes adverse events occurring post-crossover for patients in Arm A (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 41 |
Arm B (Ibrutinib) | 48 |
Arm C (Ibrutinib, Rituximab) | 39 |
All death events are due to AE, progressive disease, and other reasons. (NCT01109069)
Timeframe: 30 days after last dose of study drug
Intervention | Participants (Count of Participants) |
---|---|
IBRUTINIB/PCI-32765 | 42 |
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases. (NCT01109069)
Timeframe: 30 days after last dose of study drug, continue up to 6 months
Intervention | Participants (Count of Participants) |
---|---|
A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 199 |
A progressive disease confirmed by a CT scan. (NCT01109069)
Timeframe: 30 days after last dose of study drug, continue up to 6 months
Intervention | Participants (Count of Participants) |
---|---|
IBRUTINIB/PCI-32765 | 70 |
Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose. (NCT01105247)
Timeframe: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.
Intervention | (Number) |
---|---|
Food Effect Cohort | 1.65 |
Number of participants who had experienced at least one treatment emergent AEs. (NCT01105247)
Timeframe: From first dose to within 30 days of last dose of PCI-32765
Intervention | Participants (Number) |
---|---|
PCI-32765 | 116 |
Food Effect | 11 |
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
Intervention | Percentage of Participants (Number) |
---|---|
Treatment Naive | 71 |
Relapsed/ Refractory | 75.3 |
Food Effect | 56.3 |
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
Intervention | Percentage of Participants (Number) |
---|---|
Treatment Naive | 96.3 |
Relapsed/ Refractory | 73.6 |
Food- Effect | NA |
ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib | 82.4 |
Chlorambucil | 35.3 |
OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Months (Median) |
---|---|
Ibrutinib | NA |
Chlorambucil | NA |
"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL" (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Months (Median) |
---|---|
Ibrutinib | NA |
Chlorambucil | 18.9 |
The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 45.6 |
Chlorambucil | 20.3 |
In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 84.3 |
Chlorambucil | 45.5 |
The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 27.2 |
Chlorambucil | 11.3 |
In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 77.1 |
Chlorambucil | 42.9 |
"The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows:~Complete response (CR): all group A and group B criteria are met~Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count < 4,000/uL, normocellular bone marrow with < 30% lymphocytes without nodules~Group B criteria: improved blood count (platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL)~Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met~Group A criteria: >=50% decrease in target lymph nodes, >=50% decrease in spleen size, >=50% decrease in liver size, 50% reduction in marrow infiltrates~Group B criteria: platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL" (NCT01500733)
Timeframe: 6 months
Intervention | percentage of participants (Number) |
---|---|
Elderly Cohort | 93.9 |
TP53 Cohort | 95.8 |
10 reviews available for adenine and Infections
Article | Year |
---|---|
Risk of infection associated with new therapies for lymphoproliferative syndromes.
Topics: Adenine; Alemtuzumab; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Antineoplastic Agent | 2020 |
Ibrutinib dose modifications in the management of CLL.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Antineoplastic Agents; Biotransformation; Clinical Stu | 2020 |
Managing toxicities of Bruton tyrosine kinase inhibitors.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Aged; Animals; Arrhythmias, Cardiac; Arthralgia; Benza | 2020 |
BTK Inhibitors in Chronic Lymphocytic Leukemia: Biological Activity and Immune Effects.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Benzamides; Humans; Infection Control; Infections; Leu | 2021 |
Systematic review of infectious events with the Bruton tyrosine kinase inhibitor ibrutinib in the treatment of hematologic malignancies.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Antineoplastic Agents; Antineoplastic Combined Chemoth | 2018 |
Optimising outcomes for patients with chronic lymphocytic leukaemia on ibrutinib therapy: European recommendations for clinical practice.
Topics: Adenine; Anticoagulants; Antineoplastic Agents; Arthralgia; Atrial Fibrillation; Diabetes Mellitus, | 2018 |
Use of acalabrutinib in patients with mantle cell lymphoma.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Benzamides; Humans; Infection Control; Infections; Lym | 2018 |
Immunological changes with kinase inhibitor therapy for chronic lymphocytic leukemia.
Topics: Adenine; Antineoplastic Combined Chemotherapy Protocols; Autoimmune Diseases; Autoimmunity; B-Lympho | 2018 |
How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia.
Topics: Adenine; Aged; Anti-Infective Agents; Anticoagulants; Arthralgia; Atrial Fibrillation; Drug Resistan | 2019 |
Infection control in patients treated for chronic lymphocytic leukemia with ibrutinib or idelalisib: recommendations from Italian society of hematology.
Topics: Adenine; Antineoplastic Combined Chemotherapy Protocols; Hematology; Humans; Infection Control; Infe | 2019 |
5 trials available for adenine and Infections
Article | Year |
---|---|
Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, I | 2019 |
Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, I | 2019 |
Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, I | 2019 |
Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, I | 2019 |
Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202.
Topics: Adenine; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillatio | 2021 |
Risk of infectious complications in patients with chronic lymphocytic leukemia in the era of BCR inhibitors: a retrospective single institution experience.
Topics: Adenine; Adolescent; Adult; Child; Female; Follow-Up Studies; Humans; Infections; Leukemia, Lymphocy | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Partial reconstitution of humoral immunity and fewer infections in patients with chronic lymphocytic leukemia treated with ibrutinib.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Aged; Aged, 80 and over; B-Lymphocytes; Bone Marrow; F | 2015 |
5 other studies available for adenine and Infections
Article | Year |
---|---|
Severe infections in patients with lymphoproliferative diseases treated with new targeted drugs: A multicentric real-world study.
Topics: Adenine; Adolescent; Adult; Agammaglobulinaemia Tyrosine Kinase; Aged; Aged, 80 and over; Antibodies | 2021 |
Increase of immunoglobulin A during ibrutinib therapy reduces infection rate in chronic lymphocytic leukemia patients.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Immunoglobulin A; Infect | 2021 |
Infection with ibrutinib in patients with chronic lymphocytic leukemia: How strong is the association?
Topics: Adenine; Clinical Trials, Phase III as Topic; Humans; Infections; Leukemia, Lymphocytic, Chronic, B- | 2018 |
Ibrutinib in very elderly patients with relapsed/refractory chronic lymphocytic leukemia: A real-world experience of 71 patients treated in France: A study from the French Innovative Leukemia Organization (FILO) group.
Topics: Adenine; Aged; Aged, 80 and over; Antineoplastic Agents; Cardiovascular Diseases; Dose-Response Rela | 2017 |
Transient responses via regulation of mRNA stability as an immuno-logical strategy for countering infectious diseases.
Topics: Adenine; Animals; Anti-Infective Agents; Cytokines; Humans; Immunologic Capping; Infections; Protein | 2008 |