A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

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

NCT06876662

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

J2N-MC-JZ01 (Other Identifier)

27289

Details and patient eligibility

About

Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.

Enrollment: 279 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are currently enrolled and active in the originator study, 18001. A participant is considered active in the study if they are:

  • receiving study intervention
  • in the short-term follow-up period, or
  • in the long-term follow-up period.

Exclusion criteria

• Were a participant in the Phase 1b cohort of Study 18001.
• Are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend 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)

---

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