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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

Must not have

Newly diagnosed MCL: Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months at the time of consent or any class 3 (moderate) or 4 (severe) cardiac disease defined by the New York Heart Association Classification

Newly diagnosed MCL: Prior treatment with ibrutinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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).

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My liver function tests are within acceptable limits for my condition.

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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.

Exclusion Criteria

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

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I have heart problems like uncontrolled heart rhythm issues or recent heart attack.

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I have mantle cell lymphoma and have been treated with ibrutinib.

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I am not pregnant or breastfeeding.

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I do not have any serious health issues that would prevent me from safely participating in the trial.

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My heart's electrical activity is abnormal, as shown in a recent ECG.

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I haven't had major surgery or live vaccines in the last 4 weeks.

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I have been newly diagnosed with a specific type of mantle cell lymphoma.

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My heart's electrical activity is abnormal, as shown in my recent ECG.

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I do not have major gastrointestinal issues affecting absorption or bowel function.

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My MCL is resistant and needs treatment with specific strong inhibitors.

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I do not have any serious health issues that would prevent me from safely participating in the trial.

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I need treatment that involves strong inhibitors for my newly diagnosed MCL.

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My lymphoma diagnosis is new and affects my central nervous system.

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My Mantle Cell Lymphoma has a Ki-67 level of 50% or higher.

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I have a newly diagnosed MCL with a tumor 10 cm or larger.

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I have not had major gut surgery, IBS, or serious digestion problems.

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I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

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I have MCL and was previously treated with ibrutinib.

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

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 more

Secondary study objectives

Clinical benefit response (minimal response + overall response rate)

Duration of response

Duration of response in elderly patients with newly diagnosed, untreated mantle cell lymphoma

+5 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

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)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

Rituximab

1999

Completed Phase 4

~2990

Ibrutinib

2014

Completed Phase 4

~2060