Long-term pirtobrutinib continuation for people with previously treated CLL/SLL 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
Run by Eli Lilly and Company · NCT06876662 · Data updated 2026-11-12
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 279 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | pirtobrutinib |
| Locations | 36 sites (Miami, Florida and 35 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 | NCT06876662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with previously treated CLL/SLL or non-Hodgkin lymphoma who are currently active participants in the LOXO-BTK-18001 trial (receiving the study drug or in follow-up) and who are not from the Phase 1b cohort.
✕Probably not a fit
People who were not enrolled in the originator LOXO-BTK-18001 trial, those from the Phase 1b cohort, or patients with medical contraindications to pirtobrutinib are unlikely to be eligible or to gain benefit from joining this rollover study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an individual-study appendix under a master protocol that allows participants from the completed LOXO-BTK-18001 trial to transition into continued treatment or follow-up. Participants who are actively receiving the study drug or are in short- or long-term follow-up in the originator study may join, while those from the Phase 1b cohort are excluded. The main focus is collecting long-term safety and efficacy information on pirtobrutinib in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma and non-Hodgkin lymphoma. The study is being conducted at several US cancer centers where enrolled participants can continue their assigned intervention or follow-up visits.
Why it matters
Potential benefit: If successful, this could demonstrate that pirtobrutinib remains safe and maintains disease control during extended use for patients with previously treated CLL/SLL or NHL.
How similar studies have gone: Earlier studies, including the original LOXO-BTK-18001 trial, reported promising responses and a manageable safety profile for pirtobrutinib, so this follow-up builds on existing positive data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are currently enrolled and active in the originator study, LOXO-BTK-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 LOXO-BTK-18001
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 -
The Emory Clinic
Atlanta, Georgia, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Mayo Clinic- Minnesota
Rochester, Minnesota, United States Recruiting
Show 30 more locations
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University Of Nebraska Medical Center
Omaha, Nebraska, 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 -
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 -
CHU de Nantes - Hotel Dieu
Nantes, France Recruiting -
Ospedale San Raffaele
Milan, Italy 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 Recruiting -
Derriford Hospital
Plymouth, United Kingdom Recruiting -
Cayuga Cancer Center
Ithaca, New York, United States Active not recruiting -
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States Active not recruiting -
Peter MacCallum Cancer Centre
Melbourne, Australia Completed -
Linear Clinical Research
Victoria, Australia Active not recruiting -
IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
Bologna, Italy Completed -
Nagoya Medical Center
Aichi-Ken, Japan Active not recruiting -
National Cancer Center Hospital
Cho-ku, Japan Completed -
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan Active not recruiting -
Tokai University Hospital- Isehara Campus
Isehara, Japan Active not recruiting -
Tohoku University Hospital
Miyagi-Ken, Japan Active not recruiting -
Hokkaido University Hospital
Sapporo, Japan Active not 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 safety follow-up of pirtobrutinib for chronic lymphocytic leukemia and non-Hodgkin lymphoma
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.
-
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.