Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers
5 other identifiers
interventional
13
1 country
6
Brief Summary
The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer. Participants must have chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkins lymphoma. The study is open to those who completed the original study - J2N-MC-JZNJ (NCT04849416) and continue to benefit from treatment. Treatment will be given every 12 weeks and this study is expected to last about 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2025
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2025
CompletedFirst Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
April 17, 2026
April 1, 2026
4.7 years
August 29, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
Day 1 through 28 days after last dose or start of new anticancer therapy
Study Arms (1)
Pirtobrutinib
EXPERIMENTALPirtobrutinib administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Currently enrolled and active in the originator study, JZNJ. A participant is considered active in the study if they are receiving study intervention
- Agree to comply with contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
You may not qualify if:
- Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Beijing Cancer hospital
Beijing, 100142, China
Sun Yat-sen University Cancer Center
Guangzhou, 510060, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shanghai East Hospital
Shanghai, 200123, China
Blood Institute of the Chinese Academy of Medical science
Tianjin, 300020, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 9, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.