What this study is
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.
What's being tested
- Pirtobrutinib
Intervention · DRUG
Administered orally.
Study details
- 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
- Sponsor
- Eli Lilly and Company
- Conditions
- Chronic Lymphocytic Leukemia · Non-Hodgkin Lymphoma
- Enrolling
- 279 people
- Starts
- 2025-05-20
- Est. completion
- 2032-12
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Receiving study intervention
- In the short-term follow-up period, or
- In the long-term follow-up period
You can't join if
- Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (36)
34 openSylvester Comprehensive Cancer Center
Miami, Florida, United States
- Contact954-265-6549
- Alvaro Alencar · Principal investigator
RecruitingFlorida Cancer Specialists
Sarasota, Florida, United States
- Contact941-377-9993
- Manish Patel · Principal investigator
RecruitingThe Emory Clinic
Atlanta, Georgia, United States
- Contact404-778-3708
- Jonathon Cohen · Principal investigator
RecruitingNorthwestern University
Chicago, Illinois, United States
- Contact312-908-5250
- Shuo Ma · Principal investigator
RecruitingDana-Farber Cancer Institute
Boston, Massachusetts, United States
- Contact617-632-5847
- Jennifer Brown · Principal investigator
RecruitingMayo Clinic- Minnesota
Rochester, Minnesota, United States
- Contact507-284-2511
- Yucai Wang · Principal investigator
RecruitingUniversity Of Nebraska Medical Center
Omaha, Nebraska, United States
- Contact402-559-5166
- Matthew Lunning · Principal investigator
RecruitingCayuga Cancer Center
Ithaca, New York, United States
- Contact607-272-5414
- Cynthia Davis · Principal investigator
RecruitingNorthwell Health
Lake Success, New York, United States
- Contact516-734-8959
- Steven Allen · Principal investigator
RecruitingMemorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
- Contact646-608-4273
- Prioty Islam · Principal investigator
RecruitingMemorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
- Prioty Islam · Principal investigator
RecruitingDuke University Medical Center
Durham, North Carolina, United States
- Contact919-684-8111
- Matthew McKinney · Principal investigator
RecruitingOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
- Contact614-293-3196
- Jennifer Woyach · Principal investigator
RecruitingUniversity of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
- Contact215-662-3933
- Sunita Nasta · Principal investigator
RecruitingTennessee Oncology
Nashville, Tennessee, United States
- Contact615-524-4074
- Michael Byrne · Principal investigator
RecruitingUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
- Contact713-792-2860
- Michael Wang · Principal investigator
RecruitingSwedish Cancer Institute
Seattle, Washington, United States
- Contact908-208-4685
- Swathi Namburi · Principal investigator
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
- Contact414-805-4600
- Nirav Shah · Principal investigator
Recruiting
18 sites outside the US
- Recruiting
- Recruiting
- Recruiting
- Recruiting
- Recruiting
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
- Contact81120023812
- Kaname Miyashita · Principal investigator
RecruitingTokai University Hospital- Isehara Campus
Isehara, Japan
- Contact81120023812
- Yoshiaki Ogawa · Principal investigator
RecruitingTohoku University Hospital
Miyagi-Ken, Japan
- Contact81120023812
- Noriko Fukuhara · Principal investigator
RecruitingHokkaido University Hospital
Sapporo, Japan
- Contact81120023812
- Daigo Hashimoto · Principal investigator
Recruiting- Recruiting
Instytut Hermatologii I Transfuzjologii
Warsaw, Poland
- Contact+48223496334
- Ewa Lech-Maranda · Principal investigator
RecruitingSeoul National University Hospital
Seoul, South Korea
- Contact+821071243234
- Ja Min Byun · Principal investigator
RecruitingSt James's University Hospital
Leeds, United Kingdom
- Contact+441132433144
- Talha Munir · Principal investigator
Recruiting- Recruiting
Derriford Hospital
Plymouth, United Kingdom
- Contact+441752431043
- David John Lewis · Principal investigator
RecruitingPeter MacCallum Cancer Centre
Melbourne, Australia
CompletedIRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
Bologna, Italy
Completed
Study team
Sponsor
Eli Lilly and Company
Study ID 27289
Study director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.