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
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Sylvester Comprehensive Cancer Center
NOT_YET_RECRUITING
Miami
Florida Cancer Specialists
RECRUITING
Sarasota
Georgia
The Emory Clinic
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Dana-Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Minnesota
Mayo Clinic- Minnesota
RECRUITING
Rochester
North Carolina
Duke University Medical Center
RECRUITING
Durham
Nebraska
University Of Nebraska Medical Center
RECRUITING
Omaha
New York
Cayuga Cancer Center
RECRUITING
Ithaca
Northwell Health
RECRUITING
Lake Success
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
RECRUITING
New York
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
RECRUITING
New York
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania Hospital
RECRUITING
Philadelphia
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Peter MacCallum Cancer Centre
COMPLETED
Melbourne
Linear Clinical Research
RECRUITING
Victoria
France
CHU de Nantes - Hotel Dieu
RECRUITING
Nantes
Italy
IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
COMPLETED
Bologna
Ospedale San Raffaele
RECRUITING
Milan
Japan
Nagoya Medical Center
RECRUITING
Aichi-ken
National Cancer Center Hospital
RECRUITING
Cho-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Tokai University Hospital- Isehara Campus
RECRUITING
Isehara
Tohoku University Hospital
RECRUITING
Miyagi-ken
Hokkaido University Hospital
RECRUITING
Sapporo
Poland
Pratia MCM Krakow
RECRUITING
Krakow
Instytut Hermatologii I Transfuzjologii
RECRUITING
Warsaw
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
United Kingdom
St James's University Hospital
RECRUITING
Leeds
Churchill Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2032-12
Participants
Target number of participants: 279
Treatments
Experimental: JZ01 Pirtobrutinib
Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA).~Pirtobrutinib administered orally.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company