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Long-term pirtobrutinib treatment for people with previously treated CLL/SLL

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 4 Interventional Eli Lilly and Company · NCT07218341

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).

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionspirtobrutinib
Locations53 sites (Mobile, Alabama and 52 other locations)
Trial IDNCT07218341 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Mobile, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

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 LeukemiaLymphoma, Small Lymphocytic
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.