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

Not Applicable

Not yet recruiting

• Conditions: Chronic Lymphocytic Leukemia; Lymphoma, Small Lymphocytic
• Interventions: Drug: Pirtobrutinib; Drug: Idelalisib

• Registration Number: NCT07218341
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-16
• Study First Submitted QC: 2025-10-16
• Study First Posted: 2025-10-20
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-19
• Last Update Posted: 2025-11-21
• Study Start: 2026-03-01
• Primary Completion: 2030-05
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• This is not applicable to this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirtobrutinib (Arm A)	Pirtobrutinib	Participants receive pirtobrutinib orally
Idelalisib (Arm B)	Idelalisib	Participants receive idelalisib orally

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)	Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from Enrollment in the 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 (1)

Cancer Specialists, LLC; 🇺🇸 Jacksonville, Florida, United States