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Chemotherapy

Ibrutinib + Rituximab + Venetoclax + Chemo 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

Kidney function above specified level

Cardiac ejection fraction within defined range

Must not have

Known human immunodeficiency virus (HIV) infection

Specific liver conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies how ibrutinib, rituximab, and venetoclax, combined with chemo, may help treat mantle cell lymphoma.

Who is the study for?

This trial is for adults with newly diagnosed mantle cell lymphoma who need treatment and have no prior therapy. They must be in good physical condition, not pregnant or breastfeeding, willing to use birth control, and free of serious medical conditions like uncontrolled hypertension or active infections.

What is being tested?

The study tests a combination of drugs (ibrutinib, rituximab, venetoclax) with chemotherapy (cytarabine, cyclophosphamide, dexamethasone, methotrexate) against mantle cell lymphoma. It aims to see if this mix can better halt cancer growth compared to current treatments.

What are the potential side effects?

Possible side effects include nausea, fatigue, hair loss from chemo; potential allergic reactions to monoclonal antibodies; increased risk of bleeding or infection due to low blood counts; liver issues; and heart problems.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is above the required level.

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My heart's pumping ability is within the normal range.

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

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My liver is working within normal ranges.

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I have been newly diagnosed with mantle cell lymphoma and have not received any treatment.

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I can do most of my daily activities by myself.

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 a specific liver condition.

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I have heart conditions or recently had a heart attack.

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I have not received any live vaccines recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Efficacy of ibrutinib plus rituximab combination followed by venetoclax

Secondary study objectives

Incidence of adverse events

Progression-free survival (PFS)

Other study objectives

Circulating tumor deoxyribonucleic acid (ctDNA) levels

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group III (ibrutinib, rituximab, venetoclax)Experimental Treatment3 Interventions

Patients receive ibrutinib, rituximab, venetoclax as in part I. Patients then receive maintenance therapy as in group I.

Group II: Group II (ibrutinib, rituximab, venetoclax, chemotherapy)Experimental Treatment9 Interventions

Patients receive ibrutinib, rituximab, and venetoclax as in part I. Patients receive combination chemotherapy as in group I. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive maintenance therapy as in group I.

Group III: Group I (ibrutinib, rituximab, venetoclax, chemotherapy)Experimental Treatment9 Interventions

Patients receive ibrutinib, rituximab, and venetoclax as described in part I. COMBINATION CHEMOTHERAPY: 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, and doxorubicin hydrochloride IV over 24 hours and vincristine sulfate IV over 15-30 minutes on day 5 of odd-numbered cycles (1 and 3). 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 3-4 of even-numbered cycles (2 and 4). Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ibrutinib and venetoclax PO QD on days 1-28, and rituximab IV over 4-8 hours on day 1 of every other month. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3330

Cyclophosphamide

2010

Completed Phase 4

~2310