UPCC 22425 A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Study on Long-Term Safety of an Investigational Medication
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Exclusion Criteria:
Exclusion criteria are defined in each ISA.
The purpose of this study is to investigate the long-term safety of an investigational medication after participants have completed earlier clinical studies. This study will include individuals from previous studies, called originator studies, and will allow them to continue receiving treatment or follow-up visits. The study will use a master protocol to guide the process, which combines individual study-specific appendices (ISAs) for each participant group from the originator studies.
Participants in this study will either continue their treatment or have follow-up visits. The study aims to ensure the ongoing safety of the investigational medication. Each appendix in the study will be specific to the original study the participant was part of, helping to organize and manage the data collected during this long-term safety evaluation.
- Who can participate: Participants must be part of an eligible Lilly-sponsored research study evaluating the investigational medication. Additional eligibility criteria may apply based on the specific originator study.
- Study details: Participants will continue to receive treatment or engage in follow-up visits as part of the study. This process is organized through individual study-specific appendices, which are tailored to each participant's original study.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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