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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of ibrutinib plus rituximab combination followed by venetoclax
Secondary outcome measures
Incidence of adverse events
Progression-free survival (PFS)
Other outcome measures
Circulating tumor deoxyribonucleic acid (ctDNA) levels

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
~3310
Cyclophosphamide
1995
Completed Phase 3
~3770
Dexamethasone
2007
Completed Phase 4
~2590
Methotrexate
2013
Completed Phase 4
~3800
Ibrutinib
2014
Completed Phase 3
~1880
Rituximab
1999
Completed Phase 4
~1880
Vincristine Sulfate
2005
Completed Phase 3
~10110
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,752 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,617 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
580 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03710772 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Group III (ibrutinib, rituximab, venetoclax), Group I (ibrutinib, rituximab, venetoclax, chemotherapy), Group II (ibrutinib, rituximab, venetoclax, chemotherapy)
Mantle Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03710772 — Phase 2
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03710772 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
2019. "Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03710772.
All > Mantle Cell Lymphoma
~9 spots leftby May 2025
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