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

Status and phase

Not yet enrolling
Phase 4

Conditions

Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma

Treatments

Drug: Pirtobrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06876662
2024-517760-29-00 (EU Trial (CTIS) Number)
J2N-MC-JZ01 (Other Identifier)
27289

Details and patient eligibility

About

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.

Enrollment

279 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Are currently enrolled and active in the originator study, 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 18001.
  • Are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend to breastfeed during the study or within 1 week of the last dose of study treatment.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

279 participants in 1 patient group

JZ01 Pirtobrutinib
Experimental group
Description:
Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
Treatment:
Drug: Pirtobrutinib

Trial contacts and locations

35

There are currently no registered sites for this trial.

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Timeline

Last updated: Apr 22, 2025

Start date

May 01, 2025 • 1 day ago

Today

May 02, 2025

End date

May 01, 2030 • in 4 years

Sponsor of this trial

Lead Sponsor

Data sourced from clinicaltrials.gov