Long-term safety follow-up of pirtobrutinib for chronic lymphocytic leukemia and non-Hodgkin lymphoma

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

Phase 4 Interventional Eli Lilly and Company · NCT06876649

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.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment787 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionspirtobrutinib
Locations38 sites (Jacksonville, Florida and 37 other locations)
Trial IDNCT06876649 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Long-term extension programs for other BTK inhibitors have provided useful safety data, but long-term results specific to pirtobrutinib are still limited.

Eligibility criteria

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 this trial is running

Jacksonville, Florida and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
Last reviewed 2026-06-10 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.