The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
787
Administered orally.
Cancer Specialists, LLC
Jacksonville, Florida, United States
NOT_YET_RECRUITINGSylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGThe Emory Clinic
Atlanta, Georgia, United States
Percentage of Participants with a Grade ≥3 treatment-emergent AEs
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 randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause.
Time frame: Time from randomization in a randomized Originator study, or from the first dose in a non-randomized 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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Northwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGDana-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
RECRUITINGNorthwell Health
Lake Success, New York, United States
RECRUITING...and 28 more locations