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Kinase Inhibitor
Ibrutinib + Rituximab 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
Relapsed/refractory MCL: Understand and voluntarily sign an Institutional Review Board (IRB)-approved informed consent form
Relapsed/refractory MCL: Confirmed diagnosis of mantle cell lymphoma with cluster of differentiation (CD)20 and cyclin D1 through cyclin D3 positivity in tissue biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing ibrutinib and rituximab as a treatment for mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include diarrhea, muscle pain, rash, fever from infusion reactions due to Rituximab; and bleeding problems, high blood pressure, irregular heartbeat among others from Ibrutinib. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signed the consent form for my relapsed/refractory MCL treatment study.
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My lymphoma is confirmed to be mantle cell type with specific markers.
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My MCL has come back or didn't respond to treatment, and I can care for myself.
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My kidneys work well enough (Cr clearance >= 30 mL/min).
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My lymphoma is confirmed to be mantle cell type with specific markers.
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I have newly diagnosed MCL and have signed the consent form.
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My liver function tests are within the required range for my condition.
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I am willing to receive blood product transfusions for my relapsed/refractory MCL.
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I am over 65 years old and have been newly diagnosed with MCL.
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I have newly diagnosed MCL and can care for myself.
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I can take pills without any trouble and agree to follow the study's procedures.
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My condition allows me to care for myself despite having relapsed or refractory MCL.
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My kidneys work well enough (Cr Clearance >= 30 mL/min).
Select...
My liver function tests are within acceptable limits for my condition.
Select...
I am willing to receive blood transfusions for my newly diagnosed MCL.
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I have newly diagnosed MCL and have not received any treatment for it.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade 3 or higher non-hematologic toxicity, grade 3 neutropenia, grade 4 hematologic toxicity, inability to administer full schedule and dose, or inability to receive treatment day 1 of course 2 in newly diagnosed elderly patients
Incidence of toxicity, defined as grade 3 or higher non-hematologic toxicity, grade 3 neutropenia, grade 4 hematologic toxicity, inability to administer full schedule and dose, or inability to receive treatment day 1 of course 2
Overall response (complete response and partial response) in elderly patients with newly-diagnosed, untreated mantle cell lymphoma, assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma
+1 moreSecondary outcome measures
Clinical benefit response (minimal response + overall response rate)
Duration of response
Duration of response in elderly patients with newly diagnosed, untreated mantle cell lymphoma
+6 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,689 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,554 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
517 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signed a consent form for treatment of my relapsed or refractory MCL.I have heart problems like uncontrolled heart rhythm issues or recent heart attack.I have signed the consent form for my relapsed/refractory MCL treatment study.My platelet count is at least 30,000/mm^3, or 15,000/mm^3 with bone marrow cancer.My MCL has returned or didn't respond to treatment, and I've had at least one treatment.My MCL has returned or didn't respond to treatment, and it's in my bone marrow or GI tract.I have a cancer that is more dangerous to my health than my newly diagnosed MCL.I have mantle cell lymphoma and have been treated with ibrutinib.I have a new diagnosis of MCL with a tumor under 10 cm or only in my bone marrow/GI.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 white blood cell count is sufficient despite my relapsed MCL.My kidneys work well enough (Cr clearance >= 30 mL/min).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.My white blood cell count is healthy enough for treatment.My platelet count is above the required level for my Mantle Cell Lymphoma diagnosis.I can take pills without any trouble and agree to follow the study's procedures.I do not have any serious health issues that would prevent me from safely participating in the trial.I have not had a stroke or brain bleed in the last 6 months.My heart's electrical activity is abnormal, as shown in a recent ECG.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.I haven't had cancer treatments or major surgery in the last 3 to 10 weeks.I am taking warfarin or a similar drug for my relapsed/refractory MCL.My MCL is resistant and needs treatment with specific strong inhibitors.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 can take part in all study activities and can swallow pills without trouble.I have newly diagnosed MCL and have signed the consent form.I have MCL and have been cancer-free for at least 6 months, except for certain skin cancers or cancers in remission.I have MCL and HIV or active hepatitis B, but not hepatitis C unless it's inactive.I have not had a stroke or brain bleed in the last 6 months.My lymphoma is confirmed to be mantle cell type with specific markers.My MCL has returned or didn't respond to treatment, and I've had at least one treatment.My uric acid levels are normal, possibly with the help of allopurinol.I am not pregnant or breastfeeding.I haven't had major surgery or live vaccines in the last 4 weeks.I have newly diagnosed MCL and need blood thinner medication.I have been newly diagnosed with a specific type of mantle cell lymphoma.I do not have any serious health issues that would prevent me from safely participating in the trial.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.My white blood cell count is adequate, even with my mantle cell lymphoma.I am willing to receive blood transfusions for my newly diagnosed MCL.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.If you have a type of cancer called MCL that has come back or not responded to treatment, your bilirubin level in your blood needs to be less than 1.5 mg/dl.I have another cancer that is more serious than my mantle cell lymphoma.I have newly diagnosed MCL and have not received any treatment for it.I have MCL and was previously treated with ibrutinib.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib, rituximab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample size for this clinical trial?
"Unfortunately, this clinical trial is not actively recruiting patients at present. It was originally posted on July 15th 2013 and amended for the last time on October 31st 2022. However, there are 1720 other trials currently accepting ccnd1 positive individuals as well as 522 studies admitting participants who have been prescribed Rituximab therapy."
Answered by AI
What maladies does Rituximab typically target?
"Rituximab is a popular treatment for dlbcl, however it has also been used to successfully manage b-cell lymphomas, polyangium and pemphigus vulgaris."
Answered by AI
Are new participants being welcomed into this trial?
"Clinicaltrials.gov states that this medical trial, initially posted on July 15th 2013, is not currently seeking to enroll any more patients. Nonetheless, the website lists over 2200 other institutes actively recruiting individuals for their study protocols."
Answered by AI
Has the Food and Drug Administration endorsed Rituximab for public use?
"Due to the fact that Rituximab is currently in Phase 2 trials, indicating limited evidence for safety and none for efficacy, our team at Power assigned it a score of 2 on the 1-3 scale."
Answered by AI
Are there any other investigations into the efficacy of Rituximab?
"Presently, there are 105 Phase 3 studies utilizing Rituximab and 522 active trials overall. Of those trials, 18462 locations across the globe have registered to participate in administering this medication. Notably, Ascoli Piceno is a major site for such research."
Answered by AI
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