Long-term safety follow-up of pirtobrutinib for chronic lymphocytic leukemia and non-Hodgkin lymphoma
Official title: A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib
Run by Eli Lilly and Company · NCT06876649 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 787 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | pirtobrutinib |
| Locations | 38 sites (Jacksonville, Florida and 37 other locations) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | May 2030 |
| Study ends | December 2032 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT06876649 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Long-term extension programs for other BTK inhibitors have provided useful safety data, but long-term results specific to pirtobrutinib are still limited.
Who can join: the full rules
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 it's running
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Sylvester Comprehensive Cancer Center
Miami, Florida, United States Recruiting -
Florida Cancer Specialists
Sarasota, Florida, United States 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
Show 32 more locations
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Northwell Health
Lake Success, New York, United States Recruiting -
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States 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 -
Derriford Hospital
Plymouth, United Kingdom Recruiting -
Cancer Specialists, LLC
Jacksonville, Florida, United States Not yet recruiting -
The Emory Clinic
Atlanta, Georgia, United States Not yet recruiting -
Northwestern University
Chicago, Illinois, United States Not yet 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 -
Churchill Hospital
Oxford, United Kingdom Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term pirtobrutinib continuation for people with previously treated CLL/SLL or non-Hodgkin lymphoma
People who are already taking pirtobrutinib in an earlier trial can continue the drug or their follow-up visits so doctors can see if it stays safe and keeps helping over the long term.
-
NX-5948 vs Pirtobrutinib in R/R CLL/SLL
This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.
-
Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL
This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.
-
Long-term pirtobrutinib treatment for people with previously treated CLL/SLL
This trial will test whether taking pirtobrutinib long-term is safe for people who have already been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
-
CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant
This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.
-
Comparing a BTK-targeted protein degrader (BGB-16673) with pirtobrutinib for adults with relapsed or refractory CLL or SLL
This trial tests whether BGB-16673 works better and is as safe as pirtobrutinib for adults whose CLL or SLL has come back or not responded after prior covalent BTK inhibitor treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.