Summary
This is a master protocol study called J2N-MC-JZNY that provides a framework to enable the evaluation of the long-term safety and efficacy of the drug 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.