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~12 spots leftby Jul 2026

Ibrutinib + Rituximab for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Preetesh Jain | MD Anderson Cancer Center

Overseen ByLuhua (Michael) Wang

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well ibrutinib and rituximab work in treating patients with mantle cell lymphoma that has come back or has not responded to treatment or older patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving ibrutinib and rituximab may be an effective treatment for mantle cell lymphoma.

Eligibility Criteria

This trial is for adults with relapsed/refractory Mantle Cell Lymphoma (MCL) or those over 65 newly diagnosed with MCL. Participants need functioning kidneys, acceptable liver function, and no major heart issues. They must not be pregnant, have HIV/Hepatitis B infection, or have taken Ibrutinib before.

Inclusion Criteria

I have signed the consent form for my relapsed/refractory MCL treatment study.

My lymphoma is confirmed to be mantle cell type with specific markers.

My MCL has come back or didn't respond to treatment, and I can care for myself.

My kidneys work well enough (Cr clearance >= 30 mL/min).

My lymphoma is confirmed to be mantle cell type with specific markers.

I have newly diagnosed MCL and have signed the consent form.

My liver function tests are within the required range for my condition.

I am willing to receive blood product transfusions for my relapsed/refractory MCL.

I am over 65 years old and have been newly diagnosed with MCL.

I have newly diagnosed MCL and can care for myself.

I can take pills without any trouble and agree to follow the study's procedures.

My condition allows me to care for myself despite having relapsed or refractory MCL.

My kidneys work well enough (Cr Clearance >= 30 mL/min).

My liver function tests are within acceptable limits for my condition.

I am willing to receive blood transfusions for my newly diagnosed MCL.

I have newly diagnosed MCL and have not received any treatment for it.

Exclusion Criteria

I have heart problems like uncontrolled heart rhythm issues or recent heart attack.

I have mantle cell lymphoma and have been treated with ibrutinib.

I am not pregnant or breastfeeding.

I do not have any serious health issues that would prevent me from safely participating in the trial.

My heart's electrical activity is abnormal, as shown in a recent ECG.

I haven't had major surgery or live vaccines in the last 4 weeks.

I have been newly diagnosed with a specific type of mantle cell lymphoma.

My heart's electrical activity is abnormal, as shown in my recent ECG.

I do not have major gastrointestinal issues affecting absorption or bowel function.

My MCL is resistant and needs treatment with specific strong inhibitors.

I do not have any serious health issues that would prevent me from safely participating in the trial.

I need treatment that involves strong inhibitors for my newly diagnosed MCL.

My lymphoma diagnosis is new and affects my central nervous system.

My Mantle Cell Lymphoma has a Ki-67 level of 50% or higher.

I have a newly diagnosed MCL with a tumor 10 cm or larger.

I have not had major gut surgery, IBS, or serious digestion problems.

I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

I have MCL and was previously treated with ibrutinib.

Participant Groups

The effectiveness of combining Ibrutinib and Rituximab to treat MCL is being tested. Ibrutinib blocks enzymes that cancer cells need to grow while Rituximab targets cancer cells directly. This phase II trial aims to see if this combination improves treatment outcomes.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, rituximab)Experimental Treatment3 Interventions

Patients receive ibrutinib PO daily on days 1-28 and rituximab IV over 4-8 hours on days 1, 8, 15, and 22 of course 1; on day 1 of courses 3-8; and on day 1 of every other course for all subsequent courses. Treatment with rituximab repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Courses with ibrutinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Imbruvica for: