Long-term safety follow-up of pirtobrutinib for chronic lymphocytic leukemia and non-Hodgkin lymphoma
A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
This program lets people who previously received pirtobrutinib in a Lilly study continue treatment or follow-up so doctors can see if the drug remains safe over the long term.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 787 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | pirtobrutinib |
| Locations | 38 sites (Jacksonville, Florida and 37 other locations) |
| Trial ID | NCT06876649 on ClinicalTrials.gov |
What this trial studies
This master protocol creates a common framework to collect long-term safety and continued efficacy information on pirtobrutinib by enrolling participants from completed, Lilly-sponsored originator studies. Individual study-specific appendices (ISAs) will bring forward participants from each originator study so they can remain on treatment or continue follow-up visits. The protocol standardizes data collection across those ISAs to track adverse events, dosing, and long-term outcomes. Enrollment is limited to people who previously participated in eligible pirtobrutinib clinical studies and meet the ISA-specific criteria.
Who should consider this trial
Good fit: Ideal candidates are people with chronic lymphocytic leukemia or non-Hodgkin lymphoma who previously received pirtobrutinib in an eligible Lilly-sponsored clinical study and can attend a participating site.
Not a fit: People who never received pirtobrutinib, who do not meet the specific ISA criteria from their originator study, or who cannot access a participating site are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this could identify long-term side effects and help guide safer, longer-term use of pirtobrutinib for people with CLL or NHL.
How similar studies have performed: Long-term extension programs for other BTK inhibitors have provided useful safety data, but long-term results specific to pirtobrutinib are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib. Exclusion Criteria: Exclusion criteria are defined in each ISA.
Where this trial is running
Jacksonville, Florida and 37 other locations
- Cancer Specialists, LLC — Jacksonville, Florida, United States (Not_yet_recruiting)
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- The Emory Clinic — Atlanta, Georgia, United States (Not_yet_recruiting)
- Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic- Minnesota — Rochester, Minnesota, United States (Recruiting)
- University Of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Cayuga Cancer Center — Ithaca, New York, United States (Recruiting)
- Northwell Health — Lake Success, New York, United States (Recruiting)
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York — New York, New York, United States (Recruiting)
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York — New York, New York, United States (Not_yet_recruiting)
- Memorial Sloan-Kettering Cancer Center (MSKCC) - New York — New York, New York, United States (Not_yet_recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Swedish Cancer Institute — Seattle, Washington, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Flinders Medical Centre — Adelaide, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Australia (Recruiting)
- Linear Clinical Research — Victoria, Australia (Recruiting)
- CHU de Nantes - Hotel Dieu — Nantes, France (Recruiting)
- IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi — Bologna, Italy (Recruiting)
- Ospedale San Raffaele — Milan, Italy (Recruiting)
- Nagoya Medical Center — Aichi-Ken, Japan (Recruiting)
- National Cancer Center Hospital — Cho-ku, Japan (Recruiting)
- National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (Recruiting)
- Tokai University Hospital- Isehara Campus — Isehara, Japan (Recruiting)
- Tohoku University Hospital — Miyagi-Ken, Japan (Recruiting)
- Hokkaido University Hospital — Sapporo, Japan (Recruiting)
- Pratia MCM Krakow — Krakow, Poland (Recruiting)
- Instytut Hermatologii I Transfuzjologii — Warsaw, Poland (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- St James's University Hospital — Leeds, United Kingdom (Recruiting)
- Churchill Hospital — Oxford, United Kingdom (Not_yet_recruiting)
- Derriford Hospital — Plymouth, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.