A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
- Conditions
- Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT06876649
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 279
- Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JZ01 Pirtobrutinib Pirtobrutinib Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Overall Survival Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months) Overall survival is defined as the time from enrollment from the originator study until death from any cause
Related Research Topics
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Trial Locations
- Locations (36)
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
University of California Medical Center
🇺🇸San Francisco, California, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mayo Clinic- Minnesota
🇺🇸Rochester, Minnesota, United States
University Of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Northwell Health
🇺🇸Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Linear Clinical Research
🇦🇺Victoria, Australia
CHU de Nantes - Hotel Dieu
🇫🇷Nantes Cedex 1, Loire Atlantique, France
Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
Tokai University Hospital- Isehara Campus
🇯🇵Isehara, Kanagawa, Japan
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
National Cancer Center Hospital
🇯🇵Cho-ku, Tokyo, Japan
Nagoya Medical Center
🇯🇵Aichi-Ken, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Tohoku University Hospital
🇯🇵Miyagi-Ken, Japan
Hokkaido University Hospital
🇯🇵Sapporoshi, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Pratia MCM Krakow
🇵🇱Krakow, Poland
Instytut Hermatologii I Transfuzjologii
🇵🇱Warsaw, Poland
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom