A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pirtobrutinib.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France, Italy, Japan +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Overview
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.
Interventions
- Drug Pirtobrutinib
Administered orally.
Primary outcome measures
- Percentage of Participants with a Grade ≥3 treatment-emergent AEs [Time frame: 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 outcome measures (1)
- Overall Survival [Time frame: 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 criteria
Inclusion criteria
- Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.
Exclusion criteria
Exclusion criteria are defined in each ISA.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Cancer Specialists, LLC — Jacksonville
- Sylvester Comprehensive Cancer Center — Miami
- Florida Cancer Specialists — Sarasota
- The Emory Clinic — Atlanta
- Northwestern University — Chicago
- Dana-Farber Cancer Institute — Boston
- Mayo Clinic- Minnesota — Rochester
- University Of Nebraska Medical Center — Omaha
- … and 12 more centers
Japan · 6 centers
- Nagoya Medical Center — Aichi-Ken
- National Cancer Center Hospital — Cho-ku
- National Hospital Organization Kyushu Cancer Center — Fukuoka
- Tokai University Hospital- Isehara Campus — Isehara
- Tohoku University Hospital — Miyagi-Ken
- Hokkaido University Hospital — Sapporo
Australia · 3 centers
- Flinders Medical Centre — Adelaide
- Peter MacCallum Cancer Centre — Melbourne
- Linear Clinical Research — Victoria
United Kingdom · 3 centers
- St James's University Hospital — Leeds
- Churchill Hospital — Oxford
- Derriford Hospital — Plymouth
Italy · 2 centers
- IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi — Bologna
- Ospedale San Raffaele — Milan
Poland · 2 centers
- Pratia MCM Krakow — Krakow
- Instytut Hermatologii I Transfuzjologii — Warsaw
France · 1 center
- CHU de Nantes - Hotel Dieu — Nantes
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06876649 · 27202 · 2024-517760-29-00 · J2N-MC-JZNY · J2N-MC-JZ01 · J2N-MC-JZ02 · J2N-MC-JZ03