What side effects are associated with this type of intervention?

Palbociclib, a CDK4/6 inhibitor, commonly causes neutropenia, infections, fatigue, and gastrointestinal issues such as diarrhea. Ibrutinib, a BTK inhibitor, is associated with side effects including atrial fibrillation, hypertension, bleeding, infections, and diarrhea. Other common treatments for MCL, such as bendamustine plus rituximab, can cause myelosuppression, infections, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has been approved by the FDA for the treatment of Mantle Cell Lymphoma (MCL). It has shown significant efficacy in relapsed or refractory MCL. Other treatments for MCL include bortezomib, a proteasome inhibitor, and bendamustine, an alkylating agent, often used in combination with rituximab, a monoclonal antibody targeting CD20. While Palbociclib, a CDK4/6 inhibitor, is not specifically mentioned in the context of MCL, its combination with Ibrutinib is being studied for potential efficacy in this disease.

What other types of research exist?

Promising novel alternatives to Palbociclib and Ibrutinib for Mantle Cell Lymphoma patients include Zanubrutinib (a BTK inhibitor) combined with Rituximab, followed by Zanubrutinib monotherapy, as well as the combination of Palbociclib and Ibrutinib. Additionally, emerging therapies such as chimeric antigen receptor T cells (CAR-T) and bispecific T cell engagers (BiTEs) like teclistamab and AMG 701 are also being explored for their potential in treating MCL.

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BTK Inhibitor

Palbociclib + Ibrutinib for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Suzanne George, MD

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

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

Must have

Patients must have normal organ and marrow function as defined below: ANC ≥ 1000 cells/μL, unless bone marrow involvement in MCL, then ANC >500 cells/μL; Platelets ≥ 75,000 cells/μL, unless bone marrow involvement in MCL, then platelets >30,000 cells/μL; Calculated creatinine clearance ≥30mL/min; AST or ALT ≤ 2.5x ULN; Total bilirubin ≤ 1.5x ULN; QTc ≤ 480 ms

Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm by CT or MRI, PET positive lesion(s) or a peripheral blood CD5+, CD19+ lymphocyte count of at least 5,000 cells/µL.

Must not have

Subjects that have received prior CDK4/6 inhibitor will not be eligible.

Subjects that have received any prior BTK inhibitor > 90 days prior to enrollment will not be eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, palbociclib and ibrutinib, for patients with mantle cell lymphoma who have previously received treatment. Palbociclib stops cancer cells from dividing, while ibrutinib blocks signals that help cancer cells grow. The goal is to see how well this combination works in slowing down or stopping the cancer.

Who is the study for?

Adults with previously treated mantle cell lymphoma who have had at least one prior systemic therapy can join. They must be able to take oral medication, not have severe heart conditions or active infections, and agree to use effective contraception. Those with certain other cancers, recent heart attacks, or uncontrolled illnesses cannot participate.

What is being tested?

The trial is testing the combination of two drugs: Palbociclib and Ibrutinib in patients with mantle cell lymphoma that has been treated before. It's a phase II study where everyone gets both drugs for cycles of 28 days to see how well they work together.

What are the potential side effects?

Possible side effects include low blood counts leading to increased infection risk, fatigue, liver issues, diarrhea, muscle pain and shortness of breath. Some may experience allergic reactions or heart problems like fast heartbeat.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that is visible on scans or specific blood cell counts indicating cancer.

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I have undergone at least one treatment that affects my whole body.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My Mantle Cell Lymphoma (MCL) diagnosis is confirmed by specific tests.

Exclusion Criteria

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

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I have never taken CDK4/6 inhibitors for my condition.

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I have not taken any BTK inhibitor medication in the last 90 days.

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My cancer has spread to my brain.

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I am not taking strong or moderate CYP3A inhibitors or inducers.

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I have not had a heart attack in the last 6 months and do not have severe heart issues.

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I do not have a significant history of liver disease.

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I have another cancer that affects my life expectancy.

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I do not need blood transfusions for low platelet counts.

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I do not have any uncontrolled illnesses that could affect my participation.

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I do not have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression free survival

Secondary study objectives

Complete Response

Duration of response

Overall Response Rate

+2 more

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: Single ArmExperimental Treatment2 Interventions

All patients will receive palbociclib at 100 mg oral once a day for 21 days, followed by 7 days off. Ibrutinib will be administered at 560 mg oral continuously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Palbociclib

2017

Completed Phase 3

~3880

0 / 16Eligibility 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

Palbociclib, a CDK4/6 inhibitor, works by blocking cyclin-dependent kinases 4 and 6, leading to cell cycle arrest and preventing cancer cell proliferation. Ibrutinib, a BTK inhibitor, blocks Bruton's tyrosine kinase, inhibiting the B-cell receptor signaling pathway and thus the growth and survival of malignant B cells. These mechanisms are important for Mantle Cell Lymphoma patients as they offer targeted treatment options that can be more effective and less toxic than traditional chemotherapy, potentially improving outcomes and quality of life.