Umbralisib + Rituximab for Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJacob D. Soumerai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research is being done to assess Umbralisib and Rituximab as a first line therapy for Follicular Lymphoma or Marginal Zone Lymphoma.

Research Team

Jacob D. Soumerai, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults diagnosed with grade 1-3A follicular lymphoma or marginal zone lymphoma who need treatment and haven't had systemic therapy for it. They should have measurable disease, be in good physical condition (ECOG ≤2), and have normal organ function. Women of childbearing age must test negative for pregnancy and agree to use contraception.

Inclusion Criteria

My blood cell counts are within a healthy range, not due to lymphoma.

I can take care of myself but might not be able to do heavy physical work.

My kidney function, measured by creatinine or its clearance, is within the normal range.

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Exclusion Criteria

I am allergic to medications similar to umbralisib or rituximab.

I have had a stem cell transplant from a donor.

Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:

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Treatment Details

Interventions

Rituximab (Monoclonal Antibody)
Umbralisib (PI3K Inhibitor)

Trial OverviewThe trial is testing Umbralisib combined with Rituximab as a first-line treatment for patients with Follicular Lymphoma or Marginal Zone Lymphoma. It aims to evaluate the effectiveness and safety of this combination therapy in individuals who are newly diagnosed.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Umbralisib+RituximabExperimental Treatment2 Interventions

* A treatment cycle is defined as 28 consecutive days. * Umbralisib will be administered at 800 mg by mouth once daily on days 1-28 of cycles 1-24. * Rituximab will be administered at 375 mg/m2 by intravenous infusion on Cycle 1 Day 1 and may be administered at 375 mg/m2 by intravenous infusion or at 1400 mg by subcutaneous injection on days 8, 15, 22 of cycle 1, day 1 of cycles 2 to 6, then every 8 weeks starting on day 1 of cycle 7 until completion of 24 cycles of umbralisib (i.e. every other cycle for 18 cycles or 9 doses, for a total of 15 doses of rituximab), or until progression or intolerance.

Rituximab is already approved in Canada for the following indications: