RECRUITING

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Description

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 Overview

Study Details

Study overview

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.

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136-1002

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232-6422

Atlanta

The Emory Clinic, Atlanta, Georgia, United States, 30322-1013

Chicago

Northwestern University, Chicago, Illinois, United States, 60611-3013

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic- Minnesota, Rochester, Minnesota, United States, 55905

Omaha

University Of Nebraska Medical Center, Omaha, Nebraska, United States, 69198

Ithaca

Cayuga Cancer Center, Ithaca, New York, United States, 14850

Lake Success

Northwell Health, Lake Success, New York, United States, 11042-1118

New York

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York, New York, New York, United States, 10065-6007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
  • * Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2032-12