Refractory Follicular Lymphoma Clinical Trial
Official title:
A Phase 1/2 Study of Tazemetostat With Umbralisib and Ublituximab in Patients With Relapsed/Refractory Follicular Lymphoma
This phase I/II trial tests the safety, side effects, and best dose of tazemetostat and umbralisib and whether tazemetostat in combination with umbralisib and ublituximab works to shrink tumors in patients with follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractor). Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Umbralisib may help block the formation of growths that may become cancer. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving tazemetostat in combination with umbralisib and ublituximab may work better in treating follicular lymphoma.
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of a regimen combining tazemetostat, umbralisib and ublituximab in patients with relapsed/refractory follicular lymphoma (FL). II. Estimate the overall response rate (ORR) in relapsed/refractory FL patients treated with tazemetostat, umbralisib and ublituximab. SECONDARY OBJECTIVE: I. Estimate the complete response (CR) rate, time to response, duration of response (DOR), overall survival (OS) and event-free survival (EFS) in relapsed/refractory FL patients treated with tazemetostat, umbralisib and ublituximab. EXPLORATORY OBJECTIVES: I. Examine the immune effects of concurrent targeting of PI3K and EZH2 in patients with FL. II. Examine the evolution of tumor genetic profile while on therapy with tazemetostat, umbralisib and ublituximab, as determined by liquid biopsy. OUTLINE: This is a phase I, dose-escalation study of tazemetostat and umbralisib followed by a phase II trials. Patients receive ublituximab intravenously (IV) on days 1, 8, and 15 of cycle 1, day 1 of cycle 2-6, and day 1 of every 3 cycles thereafter. Patients also receive tazemetostat orally (PO) twice daily (BID) umbralisib by PO once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for 2 years. ;
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