Study on Acalabrutinib for Treating Central Nervous System Lymphoma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04906902
This clinical trial is testing the safety and effectiveness of the drug Acalabrutinib for patients with central nervous system lymphoma (CNSL) that has returned or not responded to previous treatments.
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Program Overview
This study is exploring the use of Acalabrutinib, a drug that has shown promise in lab tests and other cancers, to treat central nervous system lymphoma (CNSL) that has come back or is resistant to treatment. The study aims to determine if Acalabrutinib is safe and effective for these patients. Participants will receive the drug for up to two years, as long as it is safe and their condition does not worsen. The study is supported by AstraZeneca, which provides the drug and funding for the research.
Description
This clinical trial is an open-label study, meaning both the researchers and participants know what treatment is being given. It is divided into two phases to test the safety and how the body processes Acalabrutinib in patients with recurrent or resistant CNS lymphoma. Although Acalabrutinib is not yet approved by the FDA for this specific type of cancer, it is approved for other uses. Participants will undergo screening to determine eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. The study plans to enroll 15 to 21 participants in Phase 1 and about 28 in Phase 2. Participants will continue treatment for up to two years unless they experience serious side effects or their disease progresses.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Must be willing to follow the study schedule and procedures.
- Must be at least 18 years old.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Must have a life expectancy of more than 3 months.
- Must have a confirmed diagnosis of recurrent or resistant CNS lymphoma and have received at least one prior treatment.
- Must have enough tissue available from a brain biopsy for study purposes (Phase II only).
- Must have recovered from previous treatments to a certain level.
- Must be able to undergo an MRI scan.
- Must have adequate blood counts and organ function based on specific lab tests.
- Women of childbearing potential must use effective contraception during treatment and for 2 days after the last dose.
Exclusion Criteria
- Cannot undergo an MRI scan.
- Have a significant brain bleed.
- Have active systemic disease or uncontrolled illness.
- Have had prior treatment with BTK inhibitors.
- Have another active cancer, except for certain skin cancers or other cancers that have been disease-free for 3 years.
- Have had recent cancer treatment or radiation within 4 weeks before starting the study.
- Have significant heart disease or recent heart events.
- Have difficulty swallowing pills or have gastrointestinal issues affecting absorption.
- Have a history of certain infections or active significant infections.
- Have allergies to Acalabrutinib or its components.
- Have active bleeding disorders.
- Require certain medications that interact with the study drug.
- Have had a major surgery within 28 days before starting the study.
- Have certain liver conditions or infections.
- Are pregnant or breastfeeding.
- Are participating in another clinical trial.
- Have uncontrolled high blood pressure.
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