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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
Phase
Phase 4
Sponsor
Eli Lilly and Company
Enrollment
279
Timeline
May 2025 → Dec 2032
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
- 1Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are:
- 2receiving study intervention
- 3in the short-term follow-up period, or
- 4in the long-term follow-up period
Exclusion Criteria
- 1Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001
Locations
36 sites participating in this study
The Emory Clinic
Atlanta, Georgia 30322-1013
Jonathon Cohen
Sylvester Comprehensive Cancer Center
Miami, Florida 33136-1002
Alvaro Alencar
Florida Cancer Specialists
Sarasota, Florida 34232-6422
Manish Patel
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →