A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

StatusRecruiting
PhasePhase 4
Started

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Record History

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  1. Site contacts updated at 1 of 38 sitesv15
  2. Site contacts updated at 16 of 38 sitesv14
  3. Site contacts updated at 16 of 38 sitesv13
  4. Site contacts updated at 7 of 38 sitesv12
  5. Site details revised at 2 of 38 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 37 to 38v10
  2. Study sites: 36 to 37v9
  3. Site details revised at 1 of 36 sitesv8
  4. Site details revised at 21 of 36 sitesv7
  5. Enrollment target: 279 to 787
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: details revised at 1 of 1 entry
    v6
  6. Study sites: 43 to 36v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 36 to 43
    • Start date changed from estimate of May 2025 to May 20, 2025
    v4
  8. Study sites revised (36)v3
  9. Study sites: 1 to 36
    • Start date: Apr 2025 to May 2025
    v2
  1. Study First Submitted
  • 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 master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.
Trial Details
NCT Number NCT06876649
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
Related terms Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
Enrollment 787 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov