Clinical trial NCT06876649: A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib
Official title: A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria:

* Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment.

Primary outcomes:
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:
measure: Overall Survival
timeFrame: Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic- Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Ithaca
country: United States
facility: Cayuga Cancer Center
state: New York
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Victoria
country: Australia
facility: Linear Clinical Research
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hotel Dieu
state: Loire Atlantique
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Bologna
country: Italy
facility: IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
city: Isehara
country: Japan
facility: Tokai University Hospital- Isehara Campus
state: Kanagawa
city: Cho-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Aichi-Ken
country: Japan
facility: Nagoya Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Miyagi-Ken
country: Japan
facility: Tohoku University Hospital
city: Sapporoshi
country: Japan
facility: Hokkaido University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Warsaw
country: Poland
facility: Instytut Hermatologii I Transfuzjologii
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: