Recruiting

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

Sponsor:

Eli Lilly and Company

Code:

NCT06876662

Conditions

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pirtobrutinib

Study Details

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.

Conditions

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Study ID

NCT06876662

Start date

May 20, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

279 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JZ01 Pirtobrutinib

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

Pirtobrutinib administered orally.

Interventions

Pirtobrutinib

Administered orally.

Primary outcome measure

Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136-1002

Contacts

954-265-6549

Principal Investigator:

Alvaro Alencar

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232-6422

Contacts

941-377-9993

Principal Investigator:

Manish Patel

The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322-1013

Contacts

404-778-3708

Principal Investigator:

Jonathon Cohen

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611-3013

Contacts

312-908-5250

Principal Investigator:

Shuo Ma

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

617-632-5847

Principal Investigator:

Jennifer Brown

Mayo Clinic- Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

507-284-2511

Principal Investigator:

Yucai Wang

University Of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 69198

Contacts

402-559-5166

Principal Investigator:

Matthew Lunning

Northwell Health

Recruiting

Lake Success, New York, United States, 11042-1118

Contacts

516-734-8959

Principal Investigator:

Steven Allen

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

Recruiting

New York, New York, United States, 10065-6007

Contacts

646-608-4273

Principal Investigator:

Prioty Islam

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710-4000

Contacts

919-684-8111

Principal Investigator:

Matthew McKinney

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210-1063

Contacts

614-293-3196

Principal Investigator:

Jennifer Woyach

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

215-662-3933

Principal Investigator:

Sunita Nasta

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203-2659

Contacts

615-524-4074

Principal Investigator:

Michael Byrne

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4000

Contacts

713-792-2860

Principal Investigator:

Michael Wang

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104-3588

Contacts

908-208-4685

Principal Investigator:

Swathi Namburi

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3548

Contacts

414-805-4600

Principal Investigator:

Nirav Shah

More Information

Sponsor

Eli Lilly and Company

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-03-02.