NCT06876649

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 787 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Administered orally.

Timeline

• Start date: 2025-05-20
• Primary completion: 2030-05-01
• Completion: 2032-12-01
• First posted: 2025-03-14
• Last updated: 2026-03-02

Locations

38 sites across 8 countries: United States, Australia, France, Italy, Japan, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study