Ibrutinib + Palbociclib for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByPeter Martin

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the drug.

Eligibility Criteria

Adults with previously treated mantle cell lymphoma, confirmed by specific tests, who have measurable disease and normal organ/marrow function. They must not have had certain treatments recently and should agree to use contraception. Excluded are those with active hepatitis B/C, uncontrolled illnesses, recent major surgery or live vaccines, strong CYP3A inhibitor use within 7 days prior to the trial, or a history of stroke/heart issues within the past 6 months.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is adequate.

My liver is not severely damaged according to the NCI/Child Pugh classification.

I am not on more than 20 mg of corticosteroids daily or can reduce it below that 7 days before starting the trial.

My lymphoma diagnosis is confirmed and matches specific genetic markers.

I have a tumor that is at least 1.5 cm large or a specific blood cell count above 5,000.

I have not taken BTK or CDK4/6 inhibitors before.

I am 18 years old or older.

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

Exclusion Criteria

I haven't had a severe heart issue or uncontrolled heart condition in the last 6 months.

I am not pregnant or breastfeeding.

My cancer has not spread to my brain or spinal cord.

My cervical cancer was treated and currently shows no signs of the disease.

I have not taken strong CYP3A inhibitors in the last 7 days nor do I need them continuously.

I have not received any live vaccines in the last 4 weeks.

I can swallow pills and do not have major issues with my stomach or intestines that affect food absorption.

I do not have worsening autoimmune blood disorders in the last 4 weeks.

I do not need regular blood transfusions for low platelet counts.

I have not had a stroke or brain bleed in the last 6 months.

I have not taken warfarin or similar blood thinners in the last 28 days.

I do not have a bleeding disorder like von Willebrand's or hemophilia.

I have not had major surgery in the last 4 weeks.

I have not taken any immune system suppressing drugs in the last 28 days.

I had skin cancer (not melanoma) or a specific type of melanoma and am now cancer-free.

Participant Groups

The trial is testing the combination of two drugs: Ibrutinib and Palbociclib for treating mantle cell lymphoma that has been treated before. It aims to find out the best dose and side effects by seeing how these drugs can block enzymes needed for cancer cells' growth and make them more sensitive to treatment.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, palbociclib)Experimental Treatment4 Interventions

Patients receive ibrutinib PO QD on days 1-28 and palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: