Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

Summary

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Description

PRIMARY OBJECTIVE: I. Best overall response of complete response/partial response (CR/PR). SECONDARY OBJECTIVES: I. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival. EXPLORATORY/CORRELATIVE OBJECTIVES: I. Gene expression profiling using Lymph5Cx test. II. ...

PRIMARY OBJECTIVE: I. Best overall response of complete response/partial response (CR/PR). SECONDARY OBJECTIVES: I. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival. EXPLORATORY/CORRELATIVE OBJECTIVES: I. Gene expression profiling using Lymph5Cx test. II. Sequencing using the ion torrent platform (76 gene panel for known mutations in lymphoma). III. Sequencing of BTK and phospholipase-C gamma (PLC) to evaluate for mutations. IV. Minimal residual disease testing (MRD by flow cytometry and targeted sequencing post treatment). OUTLINE: Patients receive obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years.

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