RecruitingPhase 4NCT06876662

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

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-18001 With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Sponsor

Eli Lilly and Company

Enrollment

279 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a continuation of a previous cancer trial (LOXO-BTK-18001) for patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma who are already receiving pirtobrutinib — a targeted therapy that works by blocking a protein called BTK that cancer cells use to grow and survive. This rollover study allows participants to keep receiving the drug and be monitored long-term. **You may be eligible if...** - You are currently enrolled and active in the original pirtobrutinib study LOXO-BTK-18001 - You are still receiving the study drug, in short-term follow-up, or in long-term follow-up under that study **You may NOT be eligible if...** - You were a participant in the Phase 1b (early safety testing) cohort of the original study - You are no longer considered active in the originator study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Administered orally.

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

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Flinders Medical Centre

Adelaide, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Linear Clinical Research

Victoria, Australia

CHU de Nantes - Hotel Dieu

Nantes, France

IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Nagoya Medical Center

Aichi-Ken, Japan

National Cancer Center Hospital

Cho-ku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Tokai University Hospital- Isehara Campus

Isehara, Japan

Tohoku University Hospital

Miyagi-Ken, Japan

Hokkaido University Hospital

Sapporo, Japan

Pratia MCM Krakow

Krakow, Poland

Instytut Hermatologii I Transfuzjologii

Warsaw, Poland

Seoul National University Hospital

Seoul, South Korea

St James's University Hospital

Leeds, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06876662

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