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Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Jul 21, 2026 to Jul 13, 2027 Eligibility criteria shortened, about 10 words · Secondary endpoints: details revised at 1 of 1 entry Show 2 more changesShow less
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Completion date: Sep 20, 2025 to Jul 21, 2026v11
  3. Re-verified, no change to tracked fieldsv10
  4. Results first posted: Nov 18, 2023v9
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Completion date: Sep 20, 2023 to Sep 20, 2025 Secondary endpoints: details revised at 1 of 1 entryv7 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Primary endpoint revised Primary completion date changed from estimate of Sep 20, 2023 to Jul 31, 2022 · Secondary endpoints: 5 to 1v6 Show 2 more changesShow less
    • Primary completion date changed from estimate of Sep 20, 2023 to Jul 31, 2022
    • Secondary endpoints: 5 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Suspended to Active, Not Recruiting Enrollment target: estimated 27 to confirmed 12v5 Show 1 more changeShow less
    • Enrollment target: estimated 27 to confirmed 12
  4. Primary completion date: Sep 20, 2022 to Sep 20, 2023 Completion date: Mar 20, 2023 to Sep 20, 2023v4 Show 1 more changeShow less
    • Completion date: Mar 20, 2023 to Sep 20, 2023
  5. Trial status: Recruiting to Suspended Sponsor's reason: FDA Clinical Hold Primary completion date: Mar 20, 2023 to Sep 20, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Primary completion date: Mar 20, 2023 to Sep 20, 2022
    • Site details revised
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 20, 2021 to Mar 26, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 20, 2021 to Mar 26, 2021
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial studies the effects of acalabrutinib, umbralisib, and ublituximab in treating previously untreated mantle cell lymphoma. Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and umbralisib with ublituximab may work better in treating mantle cell lymphoma.
Trial Details
NCT Number NCT04783415
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Mantle Cell Lymphoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov