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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
279
Administered orally.
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGThe Emory Clinic
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
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
Overall Survival
Overall survival is defined as the time from enrollment from the originator study until death from any cause
Time frame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic- Minnesota
Rochester, Minnesota, United States
RECRUITINGUniversity Of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGCayuga Cancer Center
Ithaca, New York, United States
ACTIVE_NOT_RECRUITINGNorthwell Health
Lake Success, New York, United States
RECRUITINGMemorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
RECRUITING...and 26 more locations