Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byMatthew Mei

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Matthew Mei

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

Inclusion Criteria

Aspartate aminotransferase (AST) =< 2.5 x ULN

Documented informed consent of the participant and/or legally authorized representative

Age: >= 18 years

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Exclusion Criteria

Prior exposure to either a PI3K inhibitor (including but not limited to idelalisib, duvelisib, copanlisib, and umbralisib) or an EZH2 inhibitor (including but not limited to tazemetostat).

You have received a stem cell transplant from someone else in the past.

Prior therapeutic intervention with any of the following: therapeutic anticancer antibodies within 3 weeks (rituximab); radio- or toxin-immunoconjugates within 10 weeks; all other chemotherapy or radiation therapy within 3 weeks prior to day 1 of protocol therapy.

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Treatment Details

Interventions

Tazemetostat (Epigenetic Modifier)
Ublituximab (Monoclonal Antibodies)
Umbralisib (PI3K Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (tazemetostat, umbralisib, ublituximab)Experimental Treatment3 Interventions

Patients receive ublituximab 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 PO BID umbralisib by PO QD on days 1-28. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity.