What side effects are associated with this type of intervention?

The most common treatments for Mantle Cell Lymphoma (MCL) include Ibrutinib, Lenalidomide, and Rituximab. Ibrutinib is associated with side effects such as atrial fibrillation, hypertension, and increased risk of infections. Lenalidomide can cause serious infections, cytopenias, and thromboembolic events. Rituximab may lead to infusion reactions, which can be severe, especially during the first cycle of treatment. These side effects necessitate careful monitoring and management during therapy.

What prior FDA approvals exist?

Ibrutinib, a BTK inhibitor, was approved by the FDA for Mantle Cell Lymphoma (MCL) due to its effectiveness in targeting B-cell receptor signaling. Lenalidomide, an immunomodulatory drug, is approved for relapsed or refractory MCL, leveraging its immune-modulating and anti-angiogenic properties. Rituximab, a CD20 monoclonal antibody, is commonly used in combination therapies for MCL, targeting CD20-positive B-cells. These drugs are key components in the treatment of MCL and have shown significant efficacy in clinical trials.

What other types of research exist?

Promising novel alternatives for Mantle Cell Lymphoma treatment in 2024 include: 1) Acalabrutinib, another BTK inhibitor, which has shown efficacy in MCL. 2) Zanubrutinib, a newer BTK inhibitor with favorable outcomes in clinical trials. 3) Venetoclax, a BCL-2 inhibitor, which has been effective in combination therapies for MCL. 4) CAR T-cell therapies, such as KTE-X19, which have shown promising results in relapsed/refractory MCL. These alternatives offer new avenues for treatment and may provide better outcomes for patients.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Lenalidomide + Rituximab for Lymphoma

Phase 1

Waitlist Available

Led By Andre Goy, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

Histologically or cytologically confirmed diagnosis of MCL

Must not have

Concomitant use of warfarin or other Vit K antagonists

Major surgery or significant traumatic injury within 28 days of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of three drugs (ibrutinib, lenalidomide, and rituximab) in patients with mantle cell lymphoma who have not responded to other treatments. Ibrutinib stops cancer cell growth, lenalidomide boosts the immune system, and rituximab helps the immune system target cancer cells. Lenalidomide and rituximab have shown significant activity in mantle cell lymphoma, both as monotherapies and in combination. The goal is to find the best dose and see how well this combination works.

Who is the study for?

This trial is for adults over 18 with Mantle Cell Lymphoma that has come back or hasn't responded to treatment. They must have had at least one prior therapy, be in decent physical shape (ECOG ≤2), and have certain blood counts within normal ranges. Women who can have children need a negative pregnancy test and must follow specific safety programs.

What is being tested?

The study aims to find the safest dose of Ibrutinib combined with Lenalidomide/Rituximab for patients with relapsed/refractory Mantle Cell Lymphoma. It's a step-by-step process where doses are increased to determine the maximum tolerated dose or recommended phase II dose.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression such as infections, bleeding issues due to low platelets, anemia from low red blood cells, fatigue, kidney problems, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My diagnosis of mantle cell lymphoma (MCL) is confirmed by lab tests.

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My kidney function is normal, with a creatinine level below 2.

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I have MCL and have been treated before, but my condition didn't improve or has returned.

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My daily activity is significantly limited due to my health.

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My blood tests show normal organ function and I don't have severe anemia or liver issues.

Exclusion Criteria

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

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I am currently taking warfarin or similar blood thinners.

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I haven't had major surgery or a serious injury in the last 28 days.

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I do not have severe heart problems as described.

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My lymphoma has spread to my brain or spinal cord.

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I haven't had chemotherapy, radiation, or experimental drugs for my MCL in the last 21 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study

This trial's timeline: 3 weeks for screening, Varies for treatment, and response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events

Secondary study objectives

Assess Drug-drug Interaction of Combination Therapy

Assess Radiologic Progression-Free Survival

Assess Radiologic Response Rate

+1 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: Dose Escalation StudyExperimental Treatment3 Interventions

Ibrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Lenalidomide

2005

Completed Phase 3

~2240

Ibrutinib

2014

Completed Phase 4

~2060

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Mantle Cell Lymphoma (MCL) include Ibrutinib, Lenalidomide, and Rituximab. Ibrutinib, a BTK inhibitor, disrupts B-cell receptor signaling, reducing the survival and proliferation of malignant B cells. Lenalidomide, an immunomodulatory drug, enhances the immune system's ability to attack cancer cells, inhibits angiogenesis, and induces cancer cell apoptosis. Rituximab, a CD20 monoclonal antibody, leads to B cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. These treatments are vital for MCL patients as they target different pathways critical for cancer cell survival, providing a comprehensive approach to therapy.