Who is eligible for clinical trial NCT04548648?

Participants must meet the protocol's inclusion criteria for Central Nervous System Lymphoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04548648 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-13

A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas (NCT04548648)

LCCC1841: A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: UNC Lineberger Comprehensive Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to test whether giving acalabrutinib is safe and effective in controlling relapsed central nervous system (CNS) lymphoma. Currently, there are no FDA-approved treatments for relapsed CNS lymphoma. Although acalabrutinib has not been approved for the treatment of CNS lymphoma, it was approved for the treatment of another type of lymphoma (mantle cell), by the Food and Drug Administration (FDA). Acalabrutinib acts similar to another cancer drug called ibrutinib. lbrutinib was tested in several research trials for the management of CNS lymphomas, and the results were promising. Acalabrutinib and ibrutinib attack a similar target found in CNS lymphoma. Acalabrutinib may do a better job in attacking this target than ibrutinib. The study doctors will be looking to see if acalabrutinib can shrink cancer cells.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (31 items).

Location: Moffit Cancer Center — Tampa, Florida

Age range: 18 Years

🧪 Interventions in This Study

Acalabrutinib (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check 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).

Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.
Ability 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).
Age ≥18 years at the time of consent.
Subject has adequate performance status as defined by The Eastern Cooperative Oncology Group (ECOG) of ≤ 2
Subject has histological confirmation of biopsy-proven central nervous system (CNS) lymphoma or magnetic resonance imaging (MRI) findings consistent with CNS lymphoma if biopsy is not possible (due to inaccessible location). Subjects with intra-ocular lymphoma will not be excluded as long as there is also parenchymal disease.
Subject has B-cell Non-Hodgkin Lymphoma.
Subject has no evidence of systemic involvement of lymphoma confirmed by computerized tomography (CT) or positron emission tomography (PET)-CT imaging within 28 days prior to first dosing in the study.
Subject must have received at least one prior line of chemotherapy for primary or secondary CNS lymphoma.
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-Gault formula (Appendix B) Hepatic\* Bilirubin ≤ 1.5 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \>1.5 mg/dL if their conjugated bilirubin is \<1.5× ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤ 2 × ULN (in the absence of lupus anticoagulant)

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Subjects meeting any of the following exclusion criteria will not be able to participate in this study.
Prior cancer treatment that was completed less than 14 days prior to Day 1 of study dosing or if subject has not recovered from all reversible acute toxic effects of the regimen to grade ≤1 or baseline.
Prior brain radiotherapy under the following conditions:
Whole-brain radiotherapy (WBRT) that was completed less than 28 days prior to Day 1 of study dosing
Stereotactic radiosurgery (SRS) that was competed less than 14 days prior to Day 1 of study dosing.
Currently participating in or has participated in a study of an investigational agent within 28 days of first dosing with study treatment.
Subject is pregnant or breastfeeding.
Subject has active cerebrospinal fluid (CSF) involvement that requires ongoing intrathecal chemotherapy
Previous exposure to a Bruton Tyrosine Kinase (BTK) inhibitor.
Subjects with severe hepatic insufficiency, as defined by Child-Pugh Score \> 6.
Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued/replaced by an alternative therapy.
Subject requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 14 days of first dose of study drug. Subjects requires or is taking direct oral anticoagulants within 7 days of first dose of study drug.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Moffit Cancer Center — Tampa, Florida
Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
Wake Forest University,The Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina

💰 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.

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
Acalabrutinib in CNSL — Boston, Massachusetts

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.

🏛️ View Official NIH Record ↗