Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery

Summary

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Description

PRIMARY OBJECTIVE: I. To determine the recommended phase II doses of lenalidomide and ibrutinib for combination with rituximab in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of the combination of le...

PRIMARY OBJECTIVE: I. To determine the recommended phase II doses of lenalidomide and ibrutinib for combination with rituximab in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of the combination of lenalidomide, ibrutinib and rituximab in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. II. To describe any preliminary evidence of antitumor activity of the combination of lenalidomide, rituximab and ibrutinib in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma as defined by response rate, duration of response, and progression-free survival. III. To observe and record anti-tumor activity. OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive rituximab intravenously (IV) on day 1 (up to 6 cycles), lenalidomide orally (PO) once daily (QD) on days 1-21 (up to 12 cycles), and ibrutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 6 months for 10 years.

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