Long-term pirtobrutinib treatment for people with previously treated CLL/SLL
Official title: Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Run by Eli Lilly and Company · NCT07218341 · Data updated 2026-11-12
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).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | pirtobrutinib |
| Locations | 50 sites (Mobile, Alabama and 49 other locations) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | May 2030 |
| Study ends | December 2032 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07218341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with previously treated CLL or SLL who completed the earlier LOXO-BTK-20020 (NCT04666038) study and wish to continue on pirtobrutinib or continue follow-up.
✕Probably not a fit
People who have not participated in the parent study or who require a different, immediate therapy are unlikely to benefit from this long-term safety extension.
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 open-label long-term safety extension for participants who completed the parent LOXO-BTK-20020 (NCT04666038) study, providing continued access to pirtobrutinib or continued follow-up. Participants receive pirtobrutinib on a regular dosing schedule every 4 weeks and are monitored for adverse events and tolerability. The follow-up period for this extension is expected to last about five years, with periodic clinic visits and safety assessments. The trial is sponsored by Eli Lilly and conducted at several US oncology sites.
Why it matters
Potential benefit: If successful, the trial could give participants continued access to pirtobrutinib and provide important data on its long-term safety in previously treated CLL/SLL.
How similar studies have gone: Other BTK inhibitors have proven effective in CLL, and earlier trials of pirtobrutinib showed promising activity and manageable safety, so this extension aims to document longer-term tolerability.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020 Exclusion Criteria: * This is not applicable to this study
Where it's running
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Mitchell Cancer Institute
Mobile, Alabama, United States Recruiting -
Cancer Specialists, LLC
Jacksonville, Florida, United States Recruiting -
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, United States Recruiting -
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States Recruiting -
Oncology Hematology Care Inc
Cincinnati, Ohio, United States Recruiting -
Texas Oncology - Paris
Fort Worth, Texas, United States Recruiting
Show 44 more locations
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US Oncology - Texas Oncology
Kyle, Texas, United States Recruiting -
The Alfred Hospital
Melbourne, Australia Recruiting -
Sun Yat-sen University Cancer Center
Guangdong, China Recruiting -
Nanfang Hospital of Southern Medical University
Guangzhou, China Recruiting -
The First Affiliated Hospital of Nanchang University
Nanchang, China Recruiting -
Taizhou Hospital of Zhejiang Province
Taizhou, China Recruiting -
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China Recruiting -
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China Recruiting -
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China Recruiting -
Azienda Ospedaliera Universitaria Careggi
Florence, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy Recruiting -
Tokai University Hospital
Isehara, Japan Recruiting -
Pratia Onkologia Katowice
Katowice, Poland Recruiting -
Castle Hill Hospital
Hull, United Kingdom Recruiting -
St James's University Hospital
Leeds, United Kingdom Recruiting -
GenesisCare
Newmarket, United Kingdom Recruiting -
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, United States Not yet recruiting -
Cayuga Cancer Center
Ithaca, New York, United States Not yet recruiting -
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria Not yet recruiting -
AZ Delta
Roeselare, Belgium Not yet recruiting -
Princess Margaret Cancer Centre - University Health Network
Toronto, Canada Not yet recruiting -
Xuanwu Hospital Capital Medical University
Beijing, China Not yet recruiting -
Hunan Cancer Hospital
Changsha, China Not yet recruiting -
Gansu Provincial Cancer Hospital
Lanzhou, China Not yet recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Not yet recruiting -
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, China Not yet recruiting -
Henan Cancer Hospital
Zhengzhou, China Not yet recruiting -
University Hospital Center Zagreb
Zagreb, Croatia Not yet recruiting -
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia Not yet recruiting -
Centre Henri Becquerel
Rouen, France Not yet recruiting -
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary Not yet recruiting -
Debreceni Egyetem
Debrecen, Hungary Not yet recruiting -
St. James's Hospital
Dublin, Ireland Not yet recruiting -
Beaumont Hospital
Dublin, Ireland Not yet recruiting -
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel Not yet recruiting -
Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy Not yet recruiting -
Presidio Ospedaliero Papardo
Messina, Italy Not yet recruiting -
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy Not yet recruiting -
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy Not yet recruiting -
Azienda Ospedaliera S. Maria Di Terni
Terni, Italy Not yet recruiting -
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
Brzozów, Poland Not yet recruiting -
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, Poland Not yet recruiting -
Hospital Universitario Marques De Valdecilla
Santander, Spain Not yet recruiting -
Hospital Universitario Virgen Del Rocio
Seville, Spain 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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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.
-
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.
-
Time-limited combination of pirtobrutinib, venetoclax and obinutuzumab for relapsed CLL/SLL
This trial will test whether a time-limited combination of pirtobrutinib, venetoclax, and obinutuzumab can control relapsed CLL/SLL in adults who have had prior therapy.
-
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.
-
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.
-
Treatment of Chronic Lymphocytic Leukaemia with Pirtobrutinib after Zanubrutinib
This study is testing if the drug pirtobrutinib can help people with chronic lymphocytic leukaemia who didn’t respond to or relapsed after treatment with zanubrutinib.
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.