Clinical trial · Interventional
A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pirtobrutinib | Drug | Pirtobrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JZ01 Pirtobrutinib
- description
- Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
- interventionNames
- Drug: Pirtobrutinib
Primary outcomes (1)
- measure
- Percentage of Participants with a Grade ≥3 treatment-emergent AEs
- timeFrame
- Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 Months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib. Exclusion Criteria: Exclusion criteria are defined in each ISA.
References
Publications (0)
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