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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Results first posted: Jun 10, 2026
    • Secondary endpoints revised (6)
    v17
  2. Secondary endpoints: 5 to 6
    • Primary endpoint revised
    v16
  3. Re-verified, no change to tracked fieldsv15
  4. Primary completion date: Feb 22, 2028 to May 14, 2025v14 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 16 to confirmed 10
    • Study completion date: Feb 22, 2033 to Mar 14, 2030
    • Site details revised at 3 of 3 sites
  5. Eligibility criteria shortened, about 28 wordsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Interventions: Acalabrutinib (Drug), Isavuconazole (Drug) to Acalabrutinib (Drug)
    • Eligibility criteria shortened, about 210 words
    • Study description shortened, about 60 words
    • Study sites revised (3)
    v12
  2. Site contacts updated at 3 of 3 sitesv11
  3. Eligibility criteria expanded, about 37 wordsv10
  4. Study sites: 2 to 3v9
  5. Primary completion date: Dec 2023 to Feb 22, 2028
    • Study completion date: Dec 2028 to Feb 22, 2033
    v8
  6. Site contacts updated at 1 of 2 sitesv7
  7. Eligibility criteria expanded, about 45 wordsv6
  8. Enrollment target: 32 to 16
    • Eligibility criteria shortened, about 76 words
    • Study description shortened, about 185 words
    • Study title shortened, about 2 words
    v5
  9. Study Status, Study Descriptionv4
  10. Study sites: 3 to 2
    • Start date changed from estimate of Jul 2021 to Oct 15, 2020
    v3
  11. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Sep 2020 to Jul 2021
    • Study sites: 2 to 3
    • Primary completion date: Nov 2023 to Dec 2023
    • Study completion date: Nov 2028 to Dec 2028
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04548648
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Central Nervous System Lymphoma
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov