Clinical trial Recruiting at 25 sites Phase 4 Interventional Ages 18 and up

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.

More Chronic Lymphocytic Leukemia trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment279 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Drugs / interventionspirtobrutinib
Locations36 sites (Miami, Florida and 35 other locations)
StatusRecruiting
StartedMay 20, 2025
Main results expectedMay 2030
Study endsDecember 2032
Registry record updatedMarch 2, 2026
Trial IDNCT06876662 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

  • 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
  • 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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.