Clinical trial NCT06876662: A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Official 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
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: 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 criteria: Inclusion Criteria:

* Are currently enrolled and active in the originator study, 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 18001.
* Are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend 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 Frame: 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: Bologna
country: Italy
facility: IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
city: Milano
country: Italy
facility: Ospedale San Raffaele
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: Warszawa
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: