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Acalabrutinib for CNS Lymphoma
Study Summary
This trial will test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) 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.Trial Design
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Who is running the clinical trial?
Media Library
- I have had chemotherapy for CNS lymphoma before.I have been tested for hepatitis C and my PCR results are negative.I have been treated with a BTK inhibitor before.I can take part in all study activities and can swallow pills without trouble.I am 18 years old or older.I have B-cell Non-Hodgkin Lymphoma.I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.I have HIV or another serious infection that is not under control.My blood counts, kidney, liver, and clotting functions are within safe ranges.I do not have serious heart problems or recent heart attacks.I have another cancer type, but it won't affect this cancer treatment's safety or results.I can take isavuconazole to prevent fungal infection while on acalabrutinib treatment.I have B-cell Non-Hodgkin Lymphoma.I have a condition that affects how my body absorbs food.I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.I do not have any serious infections.I need ongoing spinal fluid treatment for my cancer.I have been tested for hepatitis B and agree to ongoing tests if needed.I can take part in all study activities and can swallow pills without trouble.I am a woman who can have children and have a recent negative pregnancy test.My blood counts, kidney, liver, and clotting functions are within safe ranges.I have a family history of short QT syndrome.I agree to use two forms of birth control or abstain from sex while on acalabrutinib.I am not on any medication that cannot be stopped or replaced as per the trial's requirements.I have a bleeding disorder or am currently experiencing active bleeding.I had major surgery less than 28 days before starting acalabrutinib.I can perform daily activities with little to no assistance.I have had chemotherapy for CNS lymphoma before.I am taking blood thinners like warfarin or direct oral anticoagulants.I have a history of uncontrolled AIHA or ITP.I have had brain radiotherapy but finished it more than 28 days ago for WBRT or more than 14 days ago for SRS.I can perform daily activities with little or no assistance.My liver function is not severely impaired.My recent scans show no signs of lymphoma spreading in my body.I am a woman who can have children and have a recent negative pregnancy test.I have another cancer, but it won't affect this trial's treatment.I am currently undergoing chemotherapy or immunotherapy for cancer.I am 18 years old or older.I can take isavuconazole to prevent fungal infections while on acalabrutinib treatment.I have not had a live virus vaccine in the last 28 days.I finished my last cancer treatment less than 14 days ago or still have side effects.I need medication for stomach acid and can switch to other types if needed.I have had a stroke or brain bleed in the last 6 months.My recent scans show no signs of lymphoma spreading in my body.I agree to use two forms of birth control or abstain from sex while on acalabrutinib.I have a confirmed diagnosis of CNS lymphoma, either through biopsy or MRI.
- Group 1: Open-label, single-arm
- 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
What are the odds of any negative side effects from this treatment?
"While there is some evidence that this intervention is safe, it lacks the same level of clinical data to support its efficacy. Our team at Power estimates a score of 2."
Could I enroll in this clinical trial?
"This clinical trial is admitting 16 people, within the ages of 18 and 99 who have lymphoma. It is required that participants also meet the following criteria: They must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)., The subject has adequate organ function as demonstrated by: System Laboratory Value Hematological* Absolute Neutrophil Count (ANC) ≥ 1 x 109/L Platelets ≥ 75 x 109/L Renal* Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft"
Would this medical research be open to subjects who are senior citizens?
"The age limit to participate in this clinical trial is 18-99. For context, 313 other trials are taking place that involve patients under the age of 18 while 1677 studies are focused on those over 65 years old."
What is this treatment most commonly used to heal?
"The small lymphocytic lymphoma often responds well to this treatment. Additionally, this medication has shown efficacy in treating other conditions such as mucormycosis, ≥ 1 prior therapy for mantle cell lymphoma, and chronic lymphocytic leukemia (cll)."
Are new participants still being sought for this experiment?
"That is accurate. The clinical trial mentioned is, as of now, looking for potential participants. It was first posted on October 15th 2020 and was edited most recently on March 24th 2022. There are 16 spots available at 3 different locations."
How many test subjects are involved in this experiment?
"Yes, the medical trial is still open for recruitment and this can be seen on clinicaltrials.gov. The study was first posted on October 15th 2020 and was most recently updated on March 24th 2022. So far, 16 patients have been enrolled at 3 different sites."
Has this type of research been conducted before?
"This treatment regimen has been under investigation since 2014. The first trial was sponsored by Acerta Pharma BV and took place that same year. It involved 306 participants. After the initial study, this treatment received Phase 1 & 2 drug approval in _____ . As of today, there are 80 live studies involving this treatment being conducted across 508 cities in 47 countries."
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