Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02756897|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Small Lymphocytic Lymphoma Small Lymphocytic Lymphoma Untreated Chronic Lymphocytic Leukemia Untreated Small Lymphocytic Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Venetoclax||Phase 2|
I. Estimate therapeutic activity (best response [complete response (CR)/complete response with incomplete recovery (CRi)]) of combined ibrutinib and venetoclax in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL).
I. To determine the safety of this combination strategy. II. To estimate the time to best response with this combination. III. To determine the progression-free survival (PFS) and overall survival (OS).
IV. To test pharmacodynamic endpoints and molecular interactions between these two drugs.
V. To assess the therapeutic activity (best response [CR/CRi]) in subgroups of patients defined by IGHV mutation or fluorescence in situ hybridization (FISH) subtype.
I. To study immunological and molecular changes in the peripheral blood and the bone marrow in response to ibrutinib and venetoclax.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Beginning on day 1 of course 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for minimal residual disease (MRD) after course 27 may continue treatment with ibrutinib.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||July 7, 2016|
|Estimated Primary Completion Date :||July 1, 2024|
|Estimated Study Completion Date :||July 1, 2024|
Experimental: Treatment (ibrutinib, venetoclax)
Patients receive ibrutinib PO QD on days 1-28. Beginning on day 1 of course 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for MRD after course 27 may continue treatment with ibrutinib.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Best response (complete response /complete response with incomplete recovery) of combined ibrutinib and venetoclax [ Time Frame: Up to 2 months after treatment ]For each cohort, the best response (complete response /complete response with incomplete recovery) rate will be estimated along with the exact 95% confidence interval.
- Incidence of toxicities defined as prolonged neutropenia or thrombocytopenia lasting > 42 days; febrile neutropenia; hospitalization due to infection; early death; major bleeding due to thrombocytopenia [ Time Frame: Up to 6 weeks of treatment ]Will be monitored in each disease cohort separately using the Bayesian method of Thall, Simon and Estey. Safety data will be summarized using descriptive statistics.
- Time to response with combination of ibrutinib and venetoclax [ Time Frame: Up to 8 years ]Estimated using the Kaplan-Meier method in each cohort.
- Overall survival [ Time Frame: Up to 8 years ]Estimated using the Kaplan-Meier method in each cohort.
- Progression-free survival [ Time Frame: Up to 8 years ]Estimated using the Kaplan-Meier method in each cohort.
- Complete response/complete response with incomplete recovery rate in each subgroups of patients defined by IGHV mutation or fluorescence in situ hybridization (FISH) subtype [ Time Frame: Up to 8 years ]Will be estimated along with the exact 95% confidence interval.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756897
|Contact: Nitin Jainemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nitin Jain 713-745-6080|
|Principal Investigator: Nitin Jain|
|Principal Investigator:||Nitin Jain||M.D. Anderson Cancer Center|