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

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT06876649

The master protocol J2N-MC-JZNY assesses the long-term safety and efficacy of pirtobrutinib for participants from completed Lilly-sponsored studies. Eligible participants can continue treatment or follow-up visits. Pirtobrutinib is administered orally as part of the intervention.

Patient Parameters

Program Overview

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.

Eligibility Criteria

Inclusion Criteria

  • Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria

  • Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment.

Locations

FACILITYZIPCITYSTATE
University of California Medical Center94143-2204San FranciscoCalifornia
Sylvester Comprehensive Cancer Center33136-1002MiamiFlorida
Florida Cancer Specialists34232-6422SarasotaFlorida
The Emory Clinic30322-1013AtlantaGeorgia
Northwestern University60611-3013ChicagoIllinois
Dana-Farber Cancer Institute02215BostonMassachusetts
Mayo Clinic- Minnesota55905RochesterMinnesota
University Of Nebraska Medical Center69198OmahaNebraska
Northwell Health11042-1118Lake SuccessNew York
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York10065-6007New YorkNew York

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