Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prolymphocytic Leukemia
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Small Lymphocytic Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To compare the 2-year progression-free survival (PFS) rate in treated patients. SECONDARY OBJECTIVES: I. To determine safety and tolerability, the overall response rate (ORR), the estimated PFS, changes in immune parameters (lymphocyte subpopulations, immunoglobulin levels) an...
PRIMARY OBJECTIVES: I. To compare the 2-year progression-free survival (PFS) rate in treated patients. SECONDARY OBJECTIVES: I. To determine safety and tolerability, the overall response rate (ORR), the estimated PFS, changes in immune parameters (lymphocyte subpopulations, immunoglobulin levels) and biomarker responses in relapsed chronic lymphocytic leukemia (CLL) patients receiving ibrutinib (i) versus ibrutinib and rituximab (iR). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive ibrutinib as in Arm I beginning on day 1 or 2. Patients also receive rituximab intravenously (IV) over 3-8 hours on days 1, 8, 15, and 22 of course 1 and day 1 of courses 2-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 60 days and then every 4 months for 5 years.
Tracking Information
- NCT #
- NCT02007044
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jan A Burger M.D. Anderson Cancer Center