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

February 27, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

279

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Phone Number: +61882044018
        • Principal Investigator:
          • Hui-Peng Lee
      • Melbourne, Australia, 3000
        • Completed
        • Peter MacCallum Cancer Centre
      • Victoria, Australia, 3000
        • Active, not recruiting
        • Linear Clinical Research
  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes - Hôtel Dieu
        • Principal Investigator:
          • Thomas Gastinne
        • Contact:
          • Phone Number: +33240083271
  • Italy
      • Bologna, Italy, 40138
        • Completed
        • IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Paolo Ghia
        • Contact:
          • Phone Number: +390226434797
  • Japan
      • Aichi-Ken, Japan, 4600001
        • Active, not recruiting
        • Nagoya Medical Center
      • Cho-ku, Japan, 104-0045
        • Completed
        • National Cancer Center Hospital
      • Fukuoka, Japan, 811-1395
        • Active, not recruiting
        • National Hospital Organization Kyushu Cancer Center
      • Isehara, Japan, 259-1193
        • Active, not recruiting
        • Tokai University Hospital- Isehara Campus
      • Miyagi-Ken, Japan, 9808574
        • Active, not recruiting
        • Tohoku University Hospital
      • Sapporo, Japan, 060-8648
        • Active, not recruiting
        • Hokkaido University Hospital
  • Poland
      • Krakow, Poland, 30727
        • Recruiting
        • Pratia MCM Krakow
        • Principal Investigator:
          • Wojciech Jurczak
        • Contact:
          • Phone Number: +48124003200
      • Warsaw, Poland, 02-776
        • Recruiting
        • Instytut Hermatologii I Transfuzjologii
        • Principal Investigator:
          • Ewa Lech-Maranda
        • Contact:
          • Phone Number: +48223496334
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Ja Min Byun
        • Contact:
          • Phone Number: +821071243234
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Principal Investigator:
          • Talha Munir
        • Contact:
          • Phone Number: +441132433144
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Principal Investigator:
          • Toby Eyre
        • Contact:
          • Phone Number: +447728268414
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Phone Number: +441752431043
        • Principal Investigator:
          • David John Lewis
  • United States
    • Florida
      • Miami, Florida, United States, 33136-1002
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Alvaro Alencar
        • Contact:
          • Phone Number: 954-265-6549
      • Sarasota, Florida, United States, 34232-6422
        • Recruiting
        • Florida Cancer Specialists
        • Principal Investigator:
          • Manish Patel
        • Contact:
          • Phone Number: 941-377-9993
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • The Emory Clinic
        • Principal Investigator:
          • Jonathon Cohen
        • Contact:
          • Phone Number: 404-778-3708
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Shuo Ma
        • Contact:
          • Phone Number: 312-908-5250
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Jennifer Brown
        • Contact:
          • Phone Number: 617-632-5847
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic- Minnesota
        • Principal Investigator:
          • Yucai Wang
        • Contact:
          • Phone Number: 507-284-2511
    • Nebraska
      • Omaha, Nebraska, United States, 69198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Phone Number: 402-559-5166
        • Principal Investigator:
          • Matthew Lunning
    • New York
      • Ithaca, New York, United States, 14850
        • Active, not recruiting
        • Cayuga Cancer Center
      • Lake Success, New York, United States, 11042-1118
        • Recruiting
        • Northwell Health
        • Contact:
          • Phone Number: 516-734-8959
        • Principal Investigator:
          • Steven Allen
      • New York, New York, United States, 10065-6007
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
        • Contact:
          • Phone Number: 646-608-4273
        • Principal Investigator:
          • Prioty Islam
      • New York, New York, United States, 10065-6007
        • Active, not recruiting
        • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Phone Number: 919-684-8111
        • Principal Investigator:
          • Matthew McKinney
    • Ohio
      • Columbus, Ohio, United States, 43210-1063
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Jennifer Woyach
        • Contact:
          • Phone Number: 614-293-3196
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Hospital
        • Principal Investigator:
          • Sunita Nasta
        • Contact:
          • Phone Number: 215-662-3933
    • Tennessee
      • Nashville, Tennessee, United States, 37203-2659
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Phone Number: 615-524-4074
        • Principal Investigator:
          • Michael Byrne
    • Texas
      • Houston, Texas, United States, 77030-4000
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Phone Number: 713-792-2860
        • Principal Investigator:
          • Michael Wang
    • Washington
      • Seattle, Washington, United States, 98104-3588
        • Recruiting
        • Swedish Cancer Institute
        • Principal Investigator:
          • Swathi Namburi
        • Contact:
          • Phone Number: 908-208-4685
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3548
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Nirav Shah
        • Contact:
          • Phone Number: 414-805-4600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JZ01 Pirtobrutinib

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

Pirtobrutinib administered orally.
Drug: Pirtobrutinib
Administered orally.
Other Names:
  • LOXO-305
  • LY3527727

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
Overall survival is defined as the time from enrollment from the originator study until death from any cause
Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27289
  • J2N-MC-JZ01 (Other Identifier: Eli Lilly and Company)
  • 2024-517760-29-00 (Ctis)
  • J2N-MC-JZNY (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe