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Long-term pirtobrutinib continuation for people with previously treated CLL/SLL or non-Hodgkin lymphoma

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

Phase 4 Interventional Eli Lilly and Company · NCT06876662

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.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment279 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionspirtobrutinib
Locations36 sites (Miami, Florida and 35 other locations)
Trial IDNCT06876662 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Miami, Florida and 35 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.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma
Last reviewed 2026-06-13 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.