A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib (JZNY)
Research type
Research Study
Full title
Master Protocol Title: A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib ISA Title: 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
IRAS ID
1011289
Contact name
Lars Holzhausen
Contact email
Sponsor organisation
Eli Lilly & Co.
Research summary
Study J2N-MC-JZNY (JZNY) is a master protocol to evaluate the long-term safety of pirtobrutinib. This study provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The master protocol will govern individual intervention-specific appendix for originator studies (ISAs) that will represent the individual originator
studies.
Pirtobrutinib is a novel, oral, highly potent, selective, reversible Bruton tyrosine kinase (BTK) inhibitor with pharmacological properties that enable sustained inhibition throughout the once-daily dosing interval. Pirtobrutinib is active in patients with heavily pretreated chronic lymphocytic leukemia or small lymphocytic lymphoma, including in patients who have received previous BTK inhibitors.
Participants enrolled in this study have a serious life-threatening disease with limited treatment options. Without treatment, their disease will progress and ultimately be fatal. Transitioning participants from their original clinical study to this study may provide them with access to ongoing treatments, and for specific participants, will allow them to initiate treatment with pirtobrutinib. Participants continuing long-term follow-up visits in this study will receive continued clinical monitoring after treatment has ended.
This individual ISA, J2N-MC-JZ01 (JZ01), is an appendix to the master protocol J2N-MC-JZNY (JZNY) and contains unique study elements specific for participants coming from the originator, Study LOXO-BTK-18001 (18001), and will provide the participants with the opportunity for continued access to study intervention or continued follow-up visits. This study will also provide long-term safety information. Study JZ01 is an open-label study. Visits will be every 12 weeks. Once entered in this study, participants will be followed-up for survival status until death, withdrawal of consent for survival status, or the end of the study.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0073
Date of REC Opinion
11 Mar 2025
REC opinion
Further Information Favourable Opinion