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

Phase 4

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
• Interventions: Drug: Pirtobrutinib

• Registration Number: NCT06876662
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-14
• Study Start: 2025-05-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-19
• Primary Completion: 2030-05
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 279

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JZ01 Pirtobrutinib	Pirtobrutinib	Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with a Grade ≥3 treatment-emergent AEs	Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier

Secondary Outcome Measures

Name	Time	Method
Overall Survival	[Time Frame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)	Overall survival is defined as the time from enrollment from the originator study until death from any cause

Trial Locations

Locations (36)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic- Minnesota; 🇺🇸 Rochester, Minnesota, United States

University Of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Cayuga Cancer Center; 🇺🇸 Ithaca, New York, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York; 🇺🇸 New York, New York, United States

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