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
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.
Arms & interventions
- DrugPirtobrutinib
Administered orally.
Outcome measures
Primary
Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs)
Time frame: 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
Overall Survival
Time frame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
Eligibility criteria
Study locations (18)
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136-1002
Florida Cancer Specialists
Sarasota, Florida, 34232-6422
The Emory Clinic
Atlanta, Georgia, 30322-1013
Northwestern University
Chicago, Illinois, 60611-3013
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Mayo Clinic- Minnesota
Rochester, Minnesota, 55905
University Of Nebraska Medical Center
Omaha, Nebraska, 69198
Cayuga Cancer Center
Ithaca, New York, 14850
Northwell Health
Lake Success, New York, 11042-1118
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007
Duke University Medical Center
Durham, North Carolina, 27710-4000
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1063
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Tennessee Oncology
Nashville, Tennessee, 37203-2659
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
Swedish Cancer Institute
Seattle, Washington, 98104-3588
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548