A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Lilly

Status and phase: Begins enrollment in 3 months; Phase 4

Conditions: Lymphoma, Small Lymphocytic; Chronic Lymphocytic Leukemia

Treatments: Drug: Pirtobrutinib; Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07218341

J2N-MC-JZNY (Other Identifier)

J2N-MC-JZ03 (Other Identifier)

27296

Details and patient eligibility

About

This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020

Exclusion criteria

• This is not applicable to this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Pirtobrutinib (Arm A)

Experimental group

Description:

Participants receive pirtobrutinib orally

Treatment:

Drug: Pirtobrutinib

Idelalisib (Arm B)

Experimental group

Description:

Participants receive idelalisib orally

Treatment:

Drug: Idelalisib