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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Rituximab + Chemotherapy for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Luhua (Michael) Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age =< 65 years at the time of signing the informed consent

Patients should have bi-dimensional measurable disease using the Cheson criteria

Must not have

Known HIV infection

Patients with active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ibrutinib, rituximab, and consolidation chemotherapy as a treatment for mantle cell lymphoma in young patients.

Who is the study for?

This trial is for young patients under 65 with newly diagnosed mantle cell lymphoma, who need immediate treatment and have measurable disease. They should be in good physical condition (ECOG <=2), have proper organ function, no serious medical conditions or active infections, and not be pregnant. High-risk factors like blastoid/pleomorphic variant or certain genetic mutations qualify them.

What is being tested?

The study tests a combination of the drug Ibrutinib with Rituximab and other chemotherapy drugs to see if they work better together for treating mantle cell lymphoma. It aims to block cancer growth enzymes, help the immune system attack cancer cells, and kill or stop cancer cells from dividing.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to therapy, blood disorders due to bone marrow impact, liver issues reflected by bilirubin levels, heart problems shown by ejection fraction rates, fatigue from overall treatment burden.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or younger.

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My cancer can be measured in two dimensions.

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I can take care of myself but cannot do heavy physical work.

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My kidneys are functioning well enough to clear at least 30 mL/min.

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My biopsy shows I have mantle cell lymphoma with CD20 positive.

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I have aggressive MCL with symptoms needing immediate treatment.

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I have a newly diagnosed condition and have not received any treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I have an active hepatitis B or C infection.

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I have lymphoma in my brain or spinal cord.

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I cannot take certain medications or treatments due to adverse reactions.

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I do not have severe heart issues like recent heart attacks or heart failure.

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I need to take warfarin for blood thinning.

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I have a condition that affects how my body absorbs nutrients.

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I need treatment with strong CYP3A inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (complete response + partial response)

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, rituximab, consolidation chemotherapy)Experimental Treatment11 Interventions

PART I (IBRUTINIB PLUS RITUXIMAB): Patients receive ibrutinib PO QD on days 1-28 and rituximab IV over 6-8 hours on days 1, 8, 15, and 22 of cycle 1 and then over 4 hours on day 1 of cycles 3-12. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or until patients achieve complete response. PART II (CONSOLIDATION THERAPY): Patients receive rituximab IV over 6 hours on day 1; dexamethasone PO or IV on days 1-4; cyclophosphamide IV over 3 hours BID on days 2-4; doxorubicin hydrochloride IV over 15-30 minutes on day 5; and vincristine sulfate IV over 15-30 minutes on day 5 of cycles 1, 3, 5, and 7. Patients also receive rituximab IV over 6 hours on day 1; methotrexate IV over 24 hours on day 2; and cytarabine IV over 2 hours BID on days 3 and 4 of cycles 2, 4, 6, and 8. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860