Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Summary

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Description

PRIMARY OBJECTIVE: I. Determine the recommended phase 2 dose (RP2D) and toxicity of lenalidomide, umbralisib and ublituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. Determine the overall response rate (ORR) ...

PRIMARY OBJECTIVE: I. Determine the recommended phase 2 dose (RP2D) and toxicity of lenalidomide, umbralisib and ublituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL). SECONDARY OBJECTIVES: I. Determine the overall response rate (ORR) for patients with relapsed or refractory follicular lymphoma (FL) treated at the RP2D. II. Determine duration of response (DOR), progression-free survival (PFS), time to treatment failure and overall survival (OS) for patients with relapsed or refractory FL treated at the RP2D. OUTLINE: This is a dose-escalation study of lenalidomide and umbralisib. Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 and umbralisib PO QD on days 1-28. Beginning in cycle 2, patients also receive ublituximab intravenously (IV) over 90 minutes to 4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial or complete response after cycle 6 continue treatment of lenalidomide PO QD and umbralisib PO QD for 12 additional cycles, and ublituximab IV on day 1 of subsequent even cycles (8, 10, 12, 14, 16, and 18). Patients with stable disease after cycle 6 may continue on treatment for an additional 12 cycles at the discretion of the investigator. After completion of study treatment, patients are followed up within 8 weeks, and then every 6 months for 2 years.

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