← Back to Search

Kinase Inhibitor

Ibrutinib + Palbociclib for Mantle Cell Lymphoma

Phase 1

Waitlist Available

Led By Peter Martin

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault (within 14 days before enrollment)

Subjects with currently active, clinically significant hepatic impairment (> moderate hepatic impairment according to the National Cancer Institute (NCI)/Child Pugh classification)

Must not have

Subjects with acute coronary syndrome within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities are not eligible; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant

Female subjects that are pregnant or breastfeeding are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies side effects and best dose of ibrutinib and palbociclib for patients with mantle cell lymphoma who have been treated before.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include problems related to liver function, bleeding disorders due to blood thinners like warfarin being prohibited recently before joining the study; there may also be risks associated with heart health as individuals with recent severe cardiac conditions are excluded.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

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

Select...

My lymphoma diagnosis is confirmed and matches specific genetic markers.

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

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

Select...

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

Select...

I am not pregnant or breastfeeding.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Recommended phase II dose of the combination of ibrutinib and palbociclib

Secondary study objectives

Complete response (CR) rate

Incidence of toxicities

Overall response rate (ORR)

+3 more

Other study objectives

Genetic alterations

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, 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

2017

Completed Phase 3

~3790

Ibrutinib

2014

Completed Phase 4

~2060