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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 belowSelect...
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:Select...
I am HIV positive.
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I have an active hepatitis B or C infection.
Select...
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.
Select...
I need to take warfarin for blood thinning.
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I have a condition that affects how my body absorbs nutrients.
Select...
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
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
Cytarabine
2016
Completed Phase 3
~3330
Dexamethasone
2007
Completed Phase 4
~2650
Vincristine Sulfate
2005
Completed Phase 3
~10270
Cyclophosphamide
2010
Completed Phase 4
~2310
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Ibrutinib
2014
Completed Phase 4
~2060
Doxorubicin
2012
Completed Phase 3
~8030
Methotrexate
2019
Completed Phase 4
~4400
Rituximab
1999
Completed Phase 4
~2990
Vincristine
2003
Completed Phase 4
~2970
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,650 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,013 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious medical condition.I am HIV positive.I have an active hepatitis B or C infection.I have lymphoma in my brain or spinal cord.I have had severe nerve pain or tingling in the last 2 weeks.I cannot take certain medications or treatments due to adverse reactions.I do not have severe heart issues like recent heart attacks or heart failure.I have not been treated for an infection in the last 14 days.I am 65 years old or younger.My cancer can be measured in two dimensions.I have not had major surgery in the last 4 weeks.I need to take warfarin for blood thinning.My biopsy shows I have mantle cell lymphoma with CD20 positive.I have aggressive MCL with symptoms needing immediate treatment.I have a newly diagnosed condition and have not received any treatment.I have a condition that affects how my body absorbs nutrients.My kidneys are functioning well enough to clear at least 30 mL/min.My cancer is only in my gastrointestinal tract, bone marrow, or spleen.I can take care of myself but cannot do heavy physical work.I have no other cancers, except for certain allowed types.I need treatment with strong CYP3A inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, rituximab, consolidation chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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