Clinical trial Recruiting at 22 sites Phase 4 Interventional Ages 18 and up

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).

More Chronic Lymphocytic Leukemia trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Drugs / interventionspirtobrutinib
Locations50 sites (Mobile, Alabama and 49 other locations)
StatusRecruiting
StartedMarch 9, 2026
Main results expectedMay 2030
Study endsDecember 2032
Registry record updatedNovember 4, 2026
Trial IDNCT07218341 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.