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BTK Inhibitor
Palbociclib + Ibrutinib for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Evanthia Galanis, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
Study Summary
This trial is testing a new combo treatment for mantle cell lymphoma & the primary goal is to see if it extends patients' PFS (progression-free survival).
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Secondary outcome measures
Complete Response
Duration of response
Overall Response Rate
+2 moreTrial 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 3
~1880
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
24,993 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,834 Total Patients Enrolled
Kami Maddocks, MDStudy ChairOhio State University
5 Previous Clinical Trials
241 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that is visible on scans or specific blood cell counts indicating cancer.I have undergone at least one treatment that affects my whole body.I have never taken CDK4/6 inhibitors for my condition.I have not taken any BTK inhibitor medication in the last 90 days.My cancer has spread to my brain.I am not taking strong or moderate CYP3A inhibitors or inducers.I have not had a heart attack in the last 6 months and do not have severe heart issues.I am not pregnant or have confirmed it with a test within the last week.I agree to use barrier methods of contraception during and up to 90 days after the study.I do not have a significant history of liver disease.I have another cancer that affects my life expectancy.I do not need blood transfusions for low platelet counts.I have had a stem cell transplant and am not on immunosuppressants with no major side effects.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I have recovered from side effects of previous treatments.I am not pregnant and will use effective birth control during and 90 days after the study.I have hepatitis B but am being monitored and treated.I am taking no more than 20 mg of prednisone daily for symptom management.My Mantle Cell Lymphoma (MCL) diagnosis is confirmed by specific tests.I do not have any uncontrolled illnesses that could affect my participation.I do not have a bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Ibrutinib been given the green light by the FDA?
"The safety of Ibrutinib has been rated a 2 due to the Phase 2 trial data available, which affords some insight into its security but not its efficacy."
Answered by AI
Could you elucidate on the other investigations conducted related to Ibrutinib?
"Presently, 39 clinical trials for Ibrutinib are in Phase 3 while 286 active studies exist in total. Most of the research is conducted out of Burgas, New jersey; however, there are 13765 medical sites conducting these experiments globally."
Answered by AI
What is the participant count for this clinical exploration?
"This trial requires 61 qualified patients to be enrolled. Trial locations span across America, including Medical University of South carolina - Hollings Cancer Center in Charleston and City of Hope National Medical Center in Duarte."
Answered by AI
Is there still availability for volunteers to participate in this research?
"Clinicaltrials.gov reveals that this clinical trial is presently enlisting participants, the initial posting being on September 11th 2018 and the most recent alteration occurring on September 16th 2022."
Answered by AI
What clinical applications is Ibrutinib commonly employed for?
"Ibrutinib is frequently prescribed as a treatment for chronic lymphocytic leukemia (CLL). It has also been approved to treat breast cancer, malignant neoplasms and mantle cell lymphoma (MCL)."
Answered by AI
How many locations are actively engaged in this trial?
"Eight sites are currently running this medical trial, spread across Charleston, Duarte and Ypsilanti as well as 5 other cities. Prospective participants should choose the nearest site to minimize travelling time if accepted for enrolment."
Answered by AI
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