UPCC 21425 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

Investigation of Long-Term Safety in Certain Blood Cancers

Enrolling By Invitation
18 years or above
All
Phase 4
279 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
  • Age: 18 years or above
  • Gender: All

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

This study investigates the long-term safety and effects of an investigational medication in people with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or Non-Hodgkin Lymphoma (NHL) who have already received treatment. The purpose of this study is to provide participants from a previous study with the opportunity to continue their treatment or follow-up visits to better understand the medication's safety over a longer period.

Participants will either continue their assigned study treatment or their follow-up visits. The study focuses on collecting information about the safety of the investigational medication when used for a longer time. This involves regular monitoring and assessments to ensure the medication remains safe for participants.

  • Who can participate: Participants must be currently enrolled and active in the originator study LOXO-BTK-18001, either receiving study intervention or in follow-up periods. However, those who were part of the Phase 1b cohort of the originator study are not eligible.
  • Study details: Participants will continue either their study treatment or follow-up visits from the originator study. The focus is on monitoring long-term safety through regular assessments.
Updated on 02 Mar 2026. Study ID: 25-0817
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