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

NCT ID: NCT06876662

Last Updated: 2026-01-21

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

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2032-12-31

Brief Summary

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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

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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 currently enrolled and active in the originator study, LOXO-BTK-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 LOXO-BTK-18001
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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Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

The Emory Clinic

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status 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 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 COMPLETED

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 COMPLETED

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 RECRUITING

Derriford Hospital

Plymouth, , United Kingdom

Site Status RECRUITING

Countries

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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

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

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Role: primary

954-265-6549

Role: primary

941-377-9993

Role: primary

404-778-3708

Role: primary

312-908-5250

Role: primary

617-632-5847

Role: primary

507-284-2511

Role: primary

402-559-5166

Role: primary

607-272-5414

Role: primary

516-734-8959

Role: primary

646-608-4273

Role: primary

919-684-8111

Role: primary

614-293-3196

Role: primary

215-662-3933

Role: primary

615-524-4074

Role: primary

713-792-2860

Role: primary

908-208-4685

Role: primary

414-805-4600

Role: primary

+61882044018

Role: primary

61893467600

Role: primary

+33240083271

Role: primary

+390226434797

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

81120023812

Role: primary

+48124003200

Role: primary

+48223496334

Role: primary

+821071243234

Role: primary

+441132433144

Role: primary

+447728268414

Role: primary

+441752431043

Other Identifiers

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2024-517760-29-00

Identifier Type: CTIS

Identifier Source: secondary_id

J2N-MC-JZ01

Identifier Type: OTHER

Identifier Source: secondary_id

J2N-MC-JZNY

Identifier Type: OTHER

Identifier Source: secondary_id

27289

Identifier Type: -

Identifier Source: org_study_id

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