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Ibrutinib + Chemotherapy for CNS Lymphoma
Study Summary
This trial is testing whether ibrutinib, a study drug, can be used in conjunction with an established chemotherapy regimen to treat primary central nervous system lymphoma.
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.Side effects data
From 2022 Phase 3 trial • 201 Patients • NCT03053440Trial Design
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Who is running the clinical trial?
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- My bilirubin levels are within the normal range, or slightly elevated due to Gilbert Syndrome.I am 18 years old or older.My scans show my brain tumor is growing, or my spinal fluid test confirms lymphoma.I have had a stem cell transplant from a donor.I am not using other cancer drugs except for approved supportive care.I've had recent cancer treatment or am still experiencing side effects.I have received treatment with radio- or toxin-immunoconjugates within the last 70 days.I am allergic to the study drug or have taken ibrutinib if in Arms A or B.I need more than 8 mg of dexamethasone or similar medication daily.I have serious heart issues, including recent heart attacks or uncontrolled heart conditions.I have a history of hepatitis B or C.I have a bleeding disorder such as von Willebrand's disease or hemophilia.I currently have an untreated or uncontrolled infection.My diabetes is not well-managed, with a HbA1c level over 8%.I am able to care for myself and perform daily activities.My CNS lymphoma has returned after treatment or didn't respond to treatment, or I have newly diagnosed PCNSL.I have had at least one treatment for my brain condition.My platelet count is above 75 x 109/L and I haven't had a platelet transfusion in the last 3 weeks.I agree to use effective birth control during and after the study.I am not currently using warfarin or similar blood thinners, or have stopped them for at least 7 days.I have stopped taking medications that affect liver enzymes for 2 weeks.I have not taken immunosuppressants or steroids higher than 5 mg/day for the last 28 days.I have recovered from major side effects of my previous treatment.I cannot swallow pills or have a serious gut problem affecting food absorption.I can't understand or sign the consent form due to my condition, but my legal representative can on my behalf.I am of childbearing age and have a negative pregnancy test.I have primary CNS lymphoma and haven't had any CNS treatments before.I have not had major surgery in the last 2 weeks and have no plans for surgery in the next 2 weeks.My hemoglobin is at least 8 g/dL and I haven't had a blood transfusion in the last 3 weeks.I can provide 20 slides of my initial cancer diagnosis and have treated systemic disease if I have SCNSL.I am not currently receiving treatment for cancer that has spread outside my brain.My kidney function is good based on a creatinine clearance test.I am unable to participate in all required study activities due to my health.I have severe nerve damage in my arms or legs.My lymphoma is confirmed by lab tests.My blood tests show my organs and bone marrow are working well.I am currently receiving treatment for another cancer.I can undergo spinal fluid tests.
- Group 1: Arm D: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSL
- Group 2: Arm C: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSL
- Group 3: Arm A: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSL
- Group 4: Arm B: Participants with refractory/recurrent PCNSL or refractory/recurrent SCNSL
- 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
How many participants are enrolled in this trial?
"Affirmative. The clinicaltrials.gov website reveals that this medical trial is presently looking for applicants; it was first uploaded on December 1st 2014 and the page has been revised most recently on June 6th 2022. 109 individuals are being sought after from 7 distinct healthcare facilities."
Is there still availability to join this research program?
"Confirmed. According to information hosted on the clinicaltrials.gov website, this medical trial is actively enrolling patients. The listing was first published in December 2014 and last updated June 2022."
How many medical institutions have implemented this research project?
"The list of locations taking part in the clinical trial consists of Memorial Sloan Kettering Nassau (Uniondale), Memorial Sloan Kettering Monmouth(Middletown) and MemorialSloanKetteringCancerCenterNewYork, among other 7 sites."
What conditions can Ibrutinib be deployed to alleviate?
"Ibrutinib is regularly prescribed to those suffering from stage III Hodgkin's disease. It can also potentially help patients with bladder cancer, diffuse large B-cell lymphoma (DLBCL), and meningeal leukemia manage the growth of their tumours."
To what extent has Ibrutinib been explored in other scientific research?
"In 1993, ibrutinib was first researched at the National Institutes of Health Clinical Center in Rockville Pike. Since then, there have been 1455 completed trials and a further 700 are still active. The majority of these is conducted from Uniondale, New jersey."
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