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
3 other identifiers
interventional
150
15 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2026
Longer than P75 for phase_4
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 20, 2025
CompletedStudy Start
First participant enrolled
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
April 17, 2026
April 1, 2026
4.1 years
October 16, 2025
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall Survival
Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)
Study Arms (2)
Pirtobrutinib (Arm A)
EXPERIMENTALParticipants receive pirtobrutinib orally
Idelalisib (Arm B)
EXPERIMENTALParticipants receive idelalisib orally
Interventions
Eligibility Criteria
You may qualify if:
- Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020
You may not qualify if:
- This is not applicable to this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Mitchell Cancer Institute
Mobile, Alabama, 36693, United States
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, 85711, United States
Cancer Specialists, LLC
Jacksonville, Florida, 32256, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433, United States
Cayuga Cancer Center
Ithaca, New York, 14850, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10065-6007, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45211, United States
Texas Oncology - Paris
Fort Worth, Texas, 76104, United States
US Oncology - Texas Oncology
Kyle, Texas, 78640, United States
Liverpool Hospital
Liverpool, 2170, Australia
The Alfred Hospital
Melbourne, 3004, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
AZ Delta
Roeselare, 8800, Belgium
Princess Margaret Cancer Centre - University Health Network
Toronto, M5G 2M9, Canada
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Hunan Cancer Hospital
Changsha, 410013, China
Sun Yat-sen University Cancer Center
Guangdong, 510060, China
Nanfang Hospital of Southern Medical University
Guangzhou, 510515, China
Gansu Provincial Cancer Hospital
Lanzhou, 730050, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317000, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, 300020, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, 830000, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221000, China
Henan Cancer Hospital
Zhengzhou, 450003, China
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Centre Henri Becquerel
Rouen, 76038, France
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
St. James's Hospital
Dublin, D08 NHY1, Ireland
Beaumont Hospital
Dublin, DUBLIN 9, Ireland
Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Presidio Ospedaliero Papardo
Messina, 98158, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, 06129, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00138, Italy
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Italy
Azienda Ospedaliera S. Maria Di Terni
Terni, 05100, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, 37134, Italy
Tokai University Hospital
Isehara, 259-1193, Japan
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
Brzozów, 36-200, Poland
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Instytut Hermatologii I Transfuzjologii
Warsaw, 02-776, Poland
Hospital Universitario Marques De Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41010, Spain
Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
GenesisCare
Newmarket, CB8 7XN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2025
First Posted
October 20, 2025
Study Start
March 9, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
December 1, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement