Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

Not Applicable

Recruiting

• Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; B-cell Lymphoma
• Interventions: Drug: Pirtobrutinib

• Registration Number: NCT07162181
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-07
• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Study First Posted: 2025-09-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-26
• Primary Completion: 2030-05
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pirtobrutinib	Pirtobrutinib	Pirtobrutinib administered orally.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Beijing Cancer hospital; 🇨🇳 Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Blood Institute of the Chinese Academy of Medical science; 🇨🇳 Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, China