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

Phase 4

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
• Interventions: Drug: Pirtobrutinib

• Registration Number: NCT06876649
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-14
• Study Start: 2025-05-20
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-09-26
• Primary Completion: 2030-05
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 787

Inclusion Criteria

• Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria

Exclusion criteria are defined in each ISA.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JZ01 Pirtobrutinib	Pirtobrutinib	Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with a Grade ≥3 treatment-emergent AEs	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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)	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.

Trial Locations

Locations (35)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic- Minnesota; 🇺🇸 Rochester, Minnesota, United States

University Of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Cayuga Cancer Center; 🇺🇸 Ithaca, New York, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York; 🇺🇸 New York, New York, United States

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