NCT07162181

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
49mo left

Started Aug 2025

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Aug 2025May 2030

Study Start

First participant enrolled

August 7, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

August 29, 2025

Last Update Submit

April 16, 2026

Conditions

Keywords

Small Lymphocytic LymphomaChronic Lymphocytic Leukemia

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

EXPERIMENTAL

Pirtobrutinib administered orally.

Drug: Pirtobrutinib

Interventions

Administered orally.

Also known as: Loxo-305, LY3527727
Pirtobrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Shanghai East Hospital

Shanghai, 200123, China

Location

Blood Institute of the Chinese Academy of Medical science

Tianjin, 300020, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell

Interventions

pirtobrutinib

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

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

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.

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.
More information

Locations