🏛️ Verified NIH Record • Updated 2026-06-16
Acalabrutinib in CNSL (NCT04906902)
A Phase 1/2 Study of Acalabrutinib in Recurrent or Refractory Central Nervous System Lymphoma (CNSL)
🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Dana-Farber Cancer Institute
🩺 Plain-English Summary (8th-Grade Level)
This research study is a Phase 1/2 clinical trial testing the safety, tolerance and efficacy of the drug Acalabrutinib for people with recurrent or refractory central nervous system lymphoma (CNSL).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (25 items).
Location: Brigham and Women's Hospital — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants unable to undergo MRI brain.
- Participants with \> Grade 2 intracranial hemorrhage.
- Participants with active systemic disease.
- Participants with uncontrolled intercurrent illness.
- Participants with prior exposure to BTK inhibitors
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 3 years.
- Participants who have received prior systemic anti-cancer therapy including investigational agents or radiotherapy within 4 weeks prior to dosing. OR 5 half-lives, whichever is shorter Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
- Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or corrected QT interval (QTc) \> 480 msec at screening. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study.
- Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.
- Known history of infection with HIV, prior history of PML or any active significant infection (eg, bacterial, viral, or fungal).
- Known history of hypersensitivity or anaphylaxis to acalabrutinib including active product or excipient components.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Brigham and Women's Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Participants will receive study treatment for up to 2 years as long as they do not have serious side effects and their disease does not get worse.
More studies in Central Nervous System Lymphoma
- Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies — Houston, Texas
- Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR) — Philadelphia, Pennsylvania
- LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma — Birmingham, Alabama
- Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) — Bethesda, Maryland
- A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas — Tampa, Florida
Explore by condition: All Central Nervous System Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.