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A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

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

Record History

  1. Completion date: Dec 31, 2025 to Jun 30, 2026v6
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Dec 30, 2024 to Dec 5, 2024 · Site details revised at 43 of 43 sitesv5 Show 2 more changesShow less
    • Primary completion date changed from estimate of Dec 30, 2024 to Dec 5, 2024
    • Site details revised at 43 of 43 sites
  3. Primary completion date: Feb 28, 2024 to Dec 30, 2024 Study sites: 42 to 43 · Interventions: LP-168 (Drug) to Rocbrutinib (Drug) · Eligibility criteria revised · 2 morev4 Show 5 more changesShow less
    • Study sites: 42 to 43
    • Interventions: LP-168 (Drug) to Rocbrutinib (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 11 of 12 entries
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 30 to 42 · Start date changed from estimate of Feb 28, 2023 to Feb 21, 2023v3 Show 2 more changesShow less
    • Study sites: 30 to 42
    • Start date changed from estimate of Feb 28, 2023 to Feb 21, 2023
  5. Secondary endpoints: details revised at 1 of 12 entriesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.
Trial Details
NCT Number NCT05716087
Lead Sponsor Guangzhou Lupeng Pharmaceutical Company LTD.
Conditions Mantle Cell Lymphoma (MCL)
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov