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

NCT06876649 · Eli Lilly and Company
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Official title
A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
About this study
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: Exclusion criteria are defined in each ISA.
Study design
Enrollment target: 787 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-05-20
Estimated completion: 2032-12
Last updated: 2026-03-02
Interventions
Drug: Pirtobrutinib
Primary outcomes
  • Percentage of Participants with a Grade ≥3 treatment-emergent AEs (Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (38)
Cancer Specialists, LLCNot Yet Recruiting
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
The Emory ClinicNot Yet Recruiting
Atlanta, Georgia, United States
Northwestern UniversityNot Yet Recruiting
Chicago, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic- MinnesotaRecruiting
Rochester, Minnesota, United States
University Of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Cayuga Cancer CenterRecruiting
Ithaca, New York, United States
Northwell HealthRecruiting
Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkRecruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNot Yet Recruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNot Yet Recruiting
New York, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
University of Pennsylvania HospitalRecruiting
Philadelphia, Pennsylvania, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Flinders Medical CentreRecruiting
Adelaide, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Australia
Linear Clinical ResearchRecruiting
Victoria, Australia
CHU de Nantes - Hotel DieuRecruiting
Nantes, France
IRCCS-AOU di Bologna-Policlinico S.Orsola-MalpighiRecruiting
Bologna, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Nagoya Medical CenterRecruiting
Aichi-Ken, Japan
National Cancer Center HospitalRecruiting
Cho-ku, Japan
National Hospital Organization Kyushu Cancer CenterRecruiting
Fukuoka, Japan
Tokai University Hospital- Isehara CampusRecruiting
Isehara, Japan
Tohoku University HospitalRecruiting
Miyagi-Ken, Japan
Hokkaido University HospitalRecruiting
Sapporo, Japan
Pratia MCM KrakowRecruiting
Krakow, Poland
Instytut Hermatologii I TransfuzjologiiRecruiting
Warsaw, Poland
Seoul National University HospitalRecruiting
Seoul, South Korea
St James's University HospitalRecruiting
Leeds, United Kingdom
Churchill HospitalNot Yet Recruiting
Oxford, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom
A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib · TrialPath