Recruiting

Pirtobrutinib

Sponsor:

Eli Lilly and Company

Code:

NCT06876649

Conditions

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pirtobrutinib

Study Details

Brief summary:

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.

Conditions

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Study ID

NCT06876649

Start date

May 20, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria:

Exclusion criteria are defined in each ISA.

Study Design

Enrollment

787 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 AEs [ 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

1-317-615-4559LillyTrials@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

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

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

Cayuga Cancer Center

Recruiting

Ithaca, New York, United States, 14850

Contacts

607-272-5414

Principal Investigator:

Cynthia Davis

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

Contacts

713-792-2860

Principal Investigator:

Michael Wang

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104-3588

Contacts

98104-3588

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.