Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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|ClinicalTrials.gov Identifier: NCT03128879|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|BTK Gene Mutation Chronic Lymphocytic Leukemia PLCG2 Gene Mutation Small Lymphocytic Lymphoma||Drug: Ibrutinib Drug: Venetoclax||Phase 2|
I. To estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) after receiving ibrutinib monotherapy for at least 12 months and who have high risk CLL.
I. Determine complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate after 6, 12, 18 and 24 cycles of combination therapy and to estimate the time to best response with this combination.
II. Determine the cumulative rate of bone marrow minimal residual disease (MRD)-free complete responders by an assay method with at least 0.01% sensitivity and median time to MRD-negativity.
III. Determine the safety of combined ibrutinib and venetoclax. IV. Determine the progression-free and overall survival.
Participants receive venetoclax orally (PO) once daily (QD) and ibrutinib PO QD. Courses repeat every 4 weeks for up to 24 courses in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, participants are followed up every 6-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Venetoclax (ABT-199) Added to Ibrutinib in Patients With High-Risk CLL|
|Actual Study Start Date :||June 16, 2017|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Treatment (venetoclax, ibrutinib)
Participants receive venetoclax PO QD and ibrutinib PO QD. Courses repeat every 4 weeks for up to 24 courses in the absence of disease progression or unaccepted toxicity.
- Complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate [ Time Frame: At the end of 12 courses (48 weeks) ]The complete remission rate will be calculated, with the exact 95% confidence interval.
- Incidence of adverse events grade 3 or higher [ Time Frame: At the end of 5 weeks ]Frequency tables will be used to summarize categorical variables. Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The proportion of patients with adverse events will be estimated, along with the Bayesian 95% credible interval.
- Overall survival [ Time Frame: Up to 5 years ]The Kaplan-Meier method will be used. time to best response and a Cox regression model will used to assess the association between clinical factors and overall survival.
- Progression free survival [ Time Frame: Up to 5 years ]The Kaplan-Meier method will be used. time to best response and a Cox regression model will used to assess the association between clinical factors and progression free survival.
- Minimal Residual Disease (MRD) Analysis [ Time Frame: Performed pre-treatment and after 6 months,12 months, 18 months, and 24 months ]Bone marrow examination (aspiration and biopsy) with minimal residual disease (MRD) analysis by 4-color flow cytometry will be performed to evaluate whether or not and how soon patient will achieve MRD-negative status in bone marrow.
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): NCT03128879
|Contact: Philip A. Thompsonemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Philip A. Thompson 713-792-7430|
|Principal Investigator: Philip A. Thompson|
|Principal Investigator:||Philip A Thompson||M.D. Anderson Cancer Center|