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A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

NCT ID: NCT06876649

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

787 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2032-12-31

Brief Summary

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The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JZ01 Pirtobrutinib

Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA).

Pirtobrutinib administered orally.

Group Type EXPERIMENTAL

Pirtobrutinib

Intervention Type DRUG

Administered orally.

Interventions

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Pirtobrutinib

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LOXO-305 LY3527727

Eligibility Criteria

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Inclusion Criteria

* Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Cancer Specialists, LLC

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

The Emory Clinic

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Mayo Clinic- Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

University Of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Cayuga Cancer Center

Ithaca, New York, United States

Site Status RECRUITING

Northwell Health

Lake Success, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status RECRUITING

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

New York, New York, United States

Site Status NOT_YET_RECRUITING

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

New York, New York, United States

Site Status NOT_YET_RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Swedish Cancer Institute

Seattle, Washington, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Flinders Medical Centre

Adelaide, , Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, , Australia

Site Status RECRUITING

Linear Clinical Research

Victoria, , Australia

Site Status RECRUITING

CHU de Nantes - Hotel Dieu

Nantes, , France

Site Status RECRUITING

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

Bologna, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Nagoya Medical Center

Aichi-Ken, , Japan

Site Status RECRUITING

National Cancer Center Hospital

Cho-ku, , Japan

Site Status RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status RECRUITING

Tokai University Hospital- Isehara Campus

Isehara, , Japan

Site Status RECRUITING

Tohoku University Hospital

Miyagi-Ken, , Japan

Site Status RECRUITING

Hokkaido University Hospital

Sapporo, , Japan

Site Status RECRUITING

Pratia MCM Krakow

Krakow, , Poland

Site Status RECRUITING

Instytut Hermatologii I Transfuzjologii

Warsaw, , Poland

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

St James's University Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Churchill Hospital

Oxford, , United Kingdom

Site Status NOT_YET_RECRUITING

Derriford Hospital

Plymouth, , United Kingdom

Site Status RECRUITING

Countries

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China United States Australia France Italy Japan Poland South Korea United Kingdom

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

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Other Identifiers

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J2N-MC-JZNY

Identifier Type: OTHER

Identifier Source: secondary_id

2024-517760-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

27202

Identifier Type: -

Identifier Source: org_study_id