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Copanlisib + Ibrutinib for Central Nervous System Lymphoma
Study Summary
This trial is testing if it's safe to use two drugs, copanlisib and ibrutinib, together to treat people with a brain cancer called PCNSL.
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 2021 Phase 2 trial • 24 Patients • NCT02631590Trial Design
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- My kidney function, measured by creatinine, is within normal limits.I have been newly diagnosed with primary CNS lymphoma and can receive methotrexate chemotherapy.I have previously been treated with a PI3K, AKT, or mTOR inhibitor, but ibrutinib is allowed.My high blood pressure is not controlled, even with medication.My diabetes is not well-managed, with a HbA1c level over 8%.You haven't fully recovered from the side effects of previous treatment if it still affects you significantly (like hair loss).My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).My scans or tests show my brain or spinal cancer is getting worse.My blood tests show my organs and bone marrow are working well.I haven't had a stroke, deep vein thrombosis, or lung clot in the last 3 months.I do not have HIV, hepatitis B or C, or any uncontrolled infections.I have not had major surgery within the last 2 weeks and have no plans for surgery in the next 2 weeks.I have not taken any excluded medications or therapies.I haven't had chemotherapy, radiation, or cancer antibodies in the last 21 days.I am not currently using warfarin or similar blood thinners, or can stop them 7 days before the trial.I have stopped using strong CYP3A4/5 inhibitors or inducers for 2 weeks.I stopped taking seizure medications that affect enzymes 2 weeks before starting the trial drug.I am using contraception or am not of childbearing potential.I can undergo spinal taps or Ommaya reservoir procedures.I have recovered from side effects of my previous treatment.I can provide up to 20 tissue samples from my cancer diagnosis for study.I have had a stem cell transplant or brain radiation but can still join the trial.I haven't taken any targeted cancer drugs in the last 4 weeks or less.I have had a stem cell transplant from a donor.I am 18 years old or older.I have PCNSL and cannot have standard chemotherapy, or my PCNSL has returned after treatment.I can take care of myself but might not be able to do heavy physical work.My hemoglobin is at least 8 g/dL and I haven't had a blood transfusion in the last 2 weeks.My bilirubin levels are within the normal range or slightly above.I am using or willing to use a highly effective form of birth control.I need more than 4 mg of dexamethasone or its equivalent daily.I have not taken immunosuppressants or steroids higher than 5 mg/day for the last 28 days.I haven't taken strong immune system suppressants or more than 5 mg/day of prednisone in the last 28 days.I agree to use birth control during and after the study as required.I have a bleeding disorder such as von Willebrand's disease or hemophilia.I haven't used any radio- or toxin-immunoconjugates in the last 70 days.I have a wound, ulcer, or bone fracture that is not healing.My diagnosis of primary central nervous system lymphoma is confirmed by tissue analysis.I don't have a severe infection or have finished IV treatment for one within the last 14 days.I am currently receiving treatment for another cancer.I do not have any severe illnesses that could risk my safety in the study.I do not have serious heart problems like recent heart attacks or uncontrolled heart failure.I cannot swallow pills or have serious digestive issues.My health conditions do not exclude me from participating.My platelet count is above 75 x 10^9/L without transfusions in the last 2 weeks.You should be able to undergo MRI or CT scans without any problems.
- 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
To what extent has Copanlisib been successful in managing medical conditions?
"Copanlisib is a therapeutically efficacious procedure for treating lymphoma, follicular, and mantle cell (MCL) lymphomas."
How many venues are currently hosting this clinical experiment?
"At the present moment, this clinical trial is taking place at 7 different sites. These locations are situated in Commack, Uniondale and Montvale as well as 4 other cities. To reduce burdensome transportation needs, prospective participants should take into account their proximity to these centres before enrolling."
Are there any opportunities for prospective participants to join this experiment?
"The information on clinicaltrials.gov declares that this medical study is presently enlisting participants; the trail was originally published on August 23rd 2018 and has been modified as of July 27th 2022."
Are there any prior investigations involving Copanlisib?
"The first clinical trials of copanlisib began in 2011 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. To date there have been 116 completed studies and an additional 184 that are active with many being conducted out of Commack, New jersey."
What is the exact number of participants in this research endeavor?
"Affirmative, the information posted on clinicaltrials.gov certifies that this medical study is actively recruiting patients. Initially published on August 23rd 2018 and recently updated July 27th 2022, the trial requires 45 participants to be recruited from 7 different sites."
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