Ibrutinib + Rituximab for Marginal Zone Lymphoma

Recruiting in Palo Alto (17 mi)

+13 other locations

Ariela Noy, MD - MSK Lymphoma Specialist

Overseen ByAriela Noy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.

Eligibility Criteria

This trial is for adults with untreated marginal zone lymphoma, including splenic, nodal, and extranodal types. They must have a life expectancy over 3 months and be able to perform daily activities with slight limitations (ECOG ≤2). Women of childbearing potential need a negative pregnancy test and agree to use birth control. Participants should not have severe heart conditions, bleeding disorders, central nervous system lymphoma or other serious health issues that could affect the study.

Inclusion Criteria

I agree to use effective birth control during and after the study.

My lymphoma type is confirmed as marginal zone lymphoma.

I have gastric MALT lymphoma, am H. pylori negative or didn't respond to treatment, and can't or won't have gastric radiation.

+8 more

Exclusion Criteria

I have been screened for hepatitis B and C, and if positive for HBV, I am on appropriate treatment.

Human immunodeficiency virus (HIV): NOTE: HIV is a contraindication if the subject has an active opportunistic infection (OI) within 12 months and CD4 count is below the normal range

I have no cancer history except for certain skin cancers or cancers treated over 2 years ago with no current signs.

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Participant Groups

The study tests if rituximab combined with ibrutinib is more effective than rituximab with a placebo in treating marginal zone lymphoma. Patients are randomly assigned to either the drug combo or the placebo group to compare outcomes.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ibrutinib/RituximabExperimental Treatment2 Interventions

All subjects meeting eligibility criteria will receive rituximab: 375 mg/m\^2 on days 1, 8, 15 and 22 on cycle 1.

Group II: Ibrutinib/PlaceboPlacebo Group2 Interventions

Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis. Placebo capsules will be similarly dosed at 4 capsules daily.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: