A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
6 other identifiers
interventional
787
8 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2025
Longer than P75 for phase_4
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2025
CompletedFirst Posted
Study publicly available on registry
March 14, 2025
CompletedStudy Start
First participant enrolled
May 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
March 2, 2026
February 1, 2026
5 years
March 6, 2025
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall Survival
Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 Months)
Study Arms (1)
JZ01 Pirtobrutinib
EXPERIMENTALParticipants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Cancer Specialists, LLC
Jacksonville, Florida, 32256, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002, United States
Florida Cancer Specialists
Sarasota, Florida, 34232-6422, United States
The Emory Clinic
Atlanta, Georgia, 30322-1013, United States
Northwestern University
Chicago, Illinois, 60611-3013, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic- Minnesota
Rochester, Minnesota, 55905, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 69198, United States
Cayuga Cancer Center
Ithaca, New York, 14850, United States
Northwell Health
Lake Success, New York, 11042-1118, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007, United States
Duke University Medical Center
Durham, North Carolina, 27710-4000, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1063, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Tennessee Oncology
Nashville, Tennessee, 37203-2659, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104-3588, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548, United States
Flinders Medical Centre
Adelaide, 5042, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Linear Clinical Research
Victoria, 3000, Australia
CHU de Nantes - Hotel Dieu
Nantes, 44093, France
IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Nagoya Medical Center
Aichi-Ken, 4600001, Japan
National Cancer Center Hospital
Cho-ku, 104-0045, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Tokai University Hospital- Isehara Campus
Isehara, 259-1193, Japan
Tohoku University Hospital
Miyagi-Ken, 9808574, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Pratia MCM Krakow
Krakow, 30727, Poland
Instytut Hermatologii I Transfuzjologii
Warsaw, 02776, Poland
Seoul National University Hospital
Seoul, 03080, South Korea
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2025
First Posted
March 14, 2025
Study Start
May 20, 2025
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
December 1, 2032
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.