NCT02756897

Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia

A Phase II Study of Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well venetoclax and ibrutinib work in treating patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.

Detailed description

PRIMARY OBJECTIVE: 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). SECONDARY OBJECTIVES: 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 immunoglobulin heavy chain variable (IGHV) mutation or fluorescence in situ hybridization (FISH) subtype. EXPLORATORY OBJECTIVE: I. To study immunological and molecular changes in the peripheral blood and the bone marrow in response to ibrutinib and venetoclax. OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Beginning on day 1 of cycle 4, patients also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease or who are positive for minimal residual disease (MRD) after cycle 27 may continue treatment with ibrutinib. After completion of study treatment, patients are followed up every 3-6 months.

Conditions

• Chronic Lymphocytic Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Small Lymphocytic Lymphoma
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2016-07-07
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2016-04-29
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study