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

Lilly

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma

Treatments: Drug: Pirtobrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06876649

J2N-MC-JZNY (Other Identifier)

2024-517760-29-00 (EU Trial (CTIS) Number)

27202

Details and patient eligibility

About

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.

Enrollment: 279 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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279 participants in 1 patient group

JZ01 Pirtobrutinib

Experimental group

Description:

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

Treatment:

Drug: Pirtobrutinib