Clinical trial Recruiting at 32 sites Phase 4 Interventional Ages 18 and up

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.

More Chronic Lymphocytic Leukemia trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment787 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Drugs / interventionspirtobrutinib
Locations38 sites (Jacksonville, Florida and 37 other locations)
StatusRecruiting
StartedMay 20, 2025
Main results expectedMay 2030
Study endsDecember 2032
Registry record updatedMarch 2, 2026
Trial IDNCT06876649 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

  • 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
  • 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

Similar studies

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.