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Ibrutinib + Palbociclib for Mantle Cell Lymphoma
Study Summary
This trial studies side effects and best dose of ibrutinib and palbociclib for patients with mantle cell lymphoma who have been treated before.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your white blood cell count is normal and is at least 750 cells per microliter within the past 2 weeks before joining the study.I haven't had a severe heart issue or uncontrolled heart condition in the last 6 months.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.I am willing to have biopsies before and if my cancer progresses.I am not pregnant or breastfeeding.My bilirubin levels are normal or slightly elevated due to Gilbert's disease.My cancer has not spread to my brain or spinal cord.My cancer was treated over 3 years ago, and my doctor believes it's unlikely to come back.My cervical cancer was treated and currently shows no signs of the disease.My lymphoma diagnosis is confirmed and matches specific genetic markers.You cannot be currently participating in any other experimental treatments.I have not taken strong CYP3A inhibitors in the last 7 days nor do I need them continuously.I have a tumor that is at least 1.5 cm large or a specific blood cell count above 5,000.I had a stem cell transplant over a year ago, am not on immunosuppressants, and have no major side effects.I do not need regular blood transfusions for low platelet counts.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.My organ and bone marrow function is normal without recent transfusions or growth factor support.I can swallow pills and do not have major issues with my stomach or intestines that affect food absorption.I do not have any uncontrolled illnesses or recent infections.I do not have worsening autoimmune blood disorders in the last 4 weeks.I have not had a stroke or brain bleed in the last 6 months.My kidney function, measured by creatinine clearance, is adequate.I have not received any live vaccines in the last 4 weeks.I agree to use effective birth control during and 90 days after the study.I have HIV under control, not on certain medications.I have a history of cancer but it falls within the allowed exceptions.I haven't had chemotherapy in the last 21 days, monoclonal antibody therapy in the last 6 weeks, or radiotherapy in the last 4 weeks.I have undergone at least one treatment for my condition.I had skin cancer (not melanoma) or a specific type of melanoma and am now cancer-free.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.
- Group 1: Treatment (ibrutinib, palbociclib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Ibrutinib been sanctioned by the Food and Drug Administration?
"Because this is a Phase 1 study, which means limited evidence of its safety and efficacy exists, the team at Power gave Ibrutinib a score of 1."
What is the aggregate population of participants enrolled in this trial?
"This clinical trial is not accepting new candidates presently. The first posting was on May 20th, 2014 with the latest update occurring a few months ago on September 15th, 2022. In case you are seeking other medical trials, there exist 1721 studies that cover lymphoma and 286 other investigations involving Ibrutinib which are actively recruiting participants."
Have there been any other investigations into Ibrutinib's efficacy?
"Investigated first in 2011 at the NIH Clinical Center, ibrutinib has since featured prominently in 759 completed studies. Currently 286 ongoing trials are being conducted with a majority of them located within Columbus, Ohio."
What ailments can be treated with Ibrutinib?
"The prescribed medication of choice for chronic lymphocytic leukemia (CLL) is ibruitinib. This drug can also help reduce the severity of breast cancer, malignant neoplasms and mantle cell lymphoma (MCL)."
How many healthcare centers in this state are currently conducting the experiment?
"Potential participants of this medical trial can attend 4 different sites, such as Ohio State University Comprehensive Cancer Center situated in Columbus, Washington University School of Medicine located in Saint Louis and UNC Lineberger Comprehensive Cancer Center based in Chapel Hill. Additionally there are other locations included."
What outcome is the team aiming to accomplish with this research?
"The primary outcome measure of this clinical trial, to be observed over 28 days, is the recommended phase II dose for ibrutinib and palbociclib in combination. Secondary goals include an overall response rate (ORR) according to International Working Group's revised criteria, a complete response (CR) rate measured with said criteria, as well as a partial response rate evaluated by these same standards."
Does this trial currently have openings for new participants?
"Data posted on clinicaltrials.gov shows that recruitment for this medical trial has ceased. It was initially announced to the public on May 20th 2014, and last modified on September 15th 2022; though it is no longer recruiting participants, there are an additional 2007 studies actively looking for study enrollees at this time."
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