RecruitingRecruiting
A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
NCT06876662 · Eli Lilly and Company
In plain English
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Official title
Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
About this study
Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.
Eligibility criteria
Inclusion Criteria:
* Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are:
* receiving study intervention
* in the short-term follow-up period, or
* in the long-term follow-up period
Exclusion Criteria:
* Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001
Study design
Enrollment target: 279 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 adverse events (TEAEs) (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 (36)
Sylvester Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
The Emory ClinicRecruiting
Atlanta, Georgia, United States
Northwestern UniversityRecruiting
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 CenterActive Not Recruiting
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 YorkActive Not 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 CentreCompleted
Melbourne, Australia
Linear Clinical ResearchActive Not Recruiting
Victoria, Australia
CHU de Nantes - Hotel DieuRecruiting
Nantes, France
IRCCS-AOU di Bologna-Policlinico S.Orsola-MalpighiCompleted
Bologna, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Nagoya Medical CenterActive Not Recruiting
Aichi-Ken, Japan
National Cancer Center HospitalCompleted
Cho-ku, Japan
National Hospital Organization Kyushu Cancer CenterActive Not Recruiting
Fukuoka, Japan
Tokai University Hospital- Isehara CampusActive Not Recruiting
Isehara, Japan
Tohoku University HospitalActive Not Recruiting
Miyagi-Ken, Japan
Hokkaido University HospitalActive Not Recruiting
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 HospitalRecruiting
Oxford, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom