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Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints: details revised at 2 of 5 entries
    v18
  2. Results first posted: Jul 22, 2026v17 Show 6 more changesShow less
    • Primary completion date changed from estimate of Aug 3, 2024 to Aug 3, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 41
    • Study sites: 7 to 3
    • Secondary endpoints: 7 to 5
    • Primary endpoint revised
  3. Study sites revised (7)v16
  4. Primary completion date: Sep 14, 2025 to Aug 3, 2024v15
  5. Primary completion date: Aug 3, 2024 to Sep 14, 2025
    • Study completion date: Aug 3, 2025 to Aug 3, 2028
    v14
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  1. Site details revised at 1 of 7 sitesv13
  2. Primary completion date: Aug 3, 2023 to Aug 3, 2024v12 Show 5 more changesShow less
    • Study sites: 6 to 7
    • Study completion date: Aug 3, 2028 to Aug 3, 2025
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description expanded, about 16 words
    • Eligibility criteria expanded, about 5 words
  3. Site details revised at 1 of 6 sitesv11
  4. Study sites: 4 to 6v10
  5. Re-verified, no change to tracked fieldsv9
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 14, 2022 to Aug 3, 2021
    • Site details revised at 4 of 4 sites
    v8
  7. Start date: Jan 14, 2022 to May 14, 2022v7
  8. Study sites revised (4)v6
  9. Site contacts updated at 2 of 4 sitesv5
  10. Start date: Jan 14, 2021 to Jan 14, 2022
    • Site contacts updated at 1 of 4 sites
    v4
  11. Study sites: 3 to 4v3
  12. Start date: Nov 14, 2020 to Jan 14, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.
Trial Details
NCT Number NCT04626791
Lead Sponsor Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Mantle Cell Lymphoma
Related terms Lymphoma, Mantle-Cell
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov