A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07218341

Enrollment

150

Registered

2025-10-20

Start date

2026-03-09

Completion date

2032-12-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic

Brief summary

This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.

Interventions

DRUGPirtobrutinib

Administered orally

DRUGIdelalisib

Administered orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020

Exclusion criteria

* This is not applicable to this study

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)	Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier

Secondary

Measure	Time frame	Description
Overall Survival	Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)	Overall survival is defined as the time from randomization in a randomized originator study, or from the first dose in a non-randomized originator study, until death from any cause

Countries

Australia, Austria, Belgium, Canada, China, Croatia, Czechia, France, Hungary, Ireland, Israel, Italy, Japan, Poland, Spain, United Kingdom, United States

Contacts

CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com1-317-615-4559

CONTACTPhysicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026