Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Summary

Participation Requirements

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.

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