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

September 3, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Not yet recruiting
        • The Alfred Hospital
        • Principal Investigator:
          • Constantine Tam
        • Contact:
          • Phone Number: 61396561111
  • Austria
      • Salzburg, Austria, 5020
        • Not yet recruiting
        • Lkh - Universitatsklinikum Der Pmu Salzburg
        • Principal Investigator:
          • Alexander Egle
        • Contact:
          • Phone Number: +435725525822
  • Belgium
      • Roeselare, Belgium, 8800
        • Not yet recruiting
        • AZ Delta
        • Principal Investigator:
          • Lien Deleu
        • Contact:
          • Phone Number: +3251237322
  • Canada
      • Toronto, Canada, M5G 2M9
        • Not yet recruiting
        • Princess Margaret Cancer Centre - University Health Network
        • Contact:
          • Phone Number: 4169462827
        • Principal Investigator:
          • Christine Chen
  • China
      • Beijing, China, 100053
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Phone Number: +8613691066953
        • Principal Investigator:
          • Wuhan Hui
      • Changsha, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Principal Investigator:
          • Hui Zhou
      • Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • He Huang
        • Contact:
          • Phone Number: +8613798032244
      • Guangzhou, China, 510515
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical University
        • Principal Investigator:
          • RU FENG
        • Contact:
          • Phone Number: +8613725119762
      • Lanzhou, China, 730050
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Principal Investigator:
          • Jie Cui
        • Contact:
          • Phone Number: +8613519607327
      • Nanchang, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Fei Li
        • Contact:
          • Phone Number: +86079188693682
      • Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Junning Cao
        • Contact:
          • Phone Number: +862164175590
      • Taizhou, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
          • Phone Number: +8613515861286
        • Principal Investigator:
          • Qunyi Guo
      • Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Phone Number: +8618622221227
        • Principal Investigator:
          • Lihua Qiu
      • Tianjin, China, 300020
        • Recruiting
        • Hematology Hospital of the Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Rui Lv
        • Contact:
          • Phone Number: +8622023909015
      • Xuzhou, China, 221000
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Principal Investigator:
          • Jiang Cao
        • Contact:
          • Phone Number: +86516085802297
      • Zhengzhou, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Keshu Zhou
        • Contact:
          • Phone Number: +864000371818
      • Ürümqi, China, 830000
        • Not yet recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Principal Investigator:
          • Shune Yang
        • Contact:
          • Phone Number: +869917968088
  • Croatia
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • University Hospital Center Zagreb
        • Contact:
          • Phone Number: +38512388675
        • Principal Investigator:
          • Igor Aurer
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • Fakultni nemocnice Hradec Kralove
        • Principal Investigator:
          • Martin Simkovic
        • Contact:
          • Phone Number: +420495834851
  • France
      • Rouen, France, 76038
        • Not yet recruiting
        • Centre Henri Becquerel
        • Contact:
          • Phone Number: +33232082223
        • Principal Investigator:
          • Stephane Lepretre
  • Hungary
      • Budapest, Hungary, 1097
        • Not yet recruiting
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
        • Principal Investigator:
          • Zoltan Matrai
        • Contact:
          • Phone Number: +3614558217
      • Debrecen, Hungary, 4032
        • Not yet recruiting
        • Debreceni Egyetem
        • Principal Investigator:
          • Illes Arpad
        • Contact:
          • Phone Number: +3652255196
  • Ireland
      • Dublin, Ireland, D08 NHY1
        • Not yet recruiting
        • St. James's Hospital
        • Principal Investigator:
          • Carmel Waldron
        • Contact:
          • Phone Number: +353868703651
      • Dublin, Ireland, DUBLIN 9
        • Not yet recruiting
        • Beaumont Hospital
        • Contact:
          • Phone Number: +35318092010
        • Principal Investigator:
          • Philip Murphy
  • Israel
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • Yair Herishanu
        • Contact:
          • Phone Number: 97236973576
  • Italy
      • Alessandria, Italy, 15121
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo
        • Principal Investigator:
          • Gioacchino Catania
        • Contact:
          • Phone Number: +390131207825
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Careggi
        • Principal Investigator:
          • alessandro sanna
        • Contact:
          • Phone Number: +39557947958
      • Messina, Italy, 98158
        • Not yet recruiting
        • Presidio Ospedaliero Papardo
        • Contact:
          • Phone Number: +39903992246
        • Principal Investigator:
          • Donato Mannina
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Principal Investigator:
          • Carlo Gambacorti-Passerini
        • Contact:
          • Phone Number: +390392331
      • Perugia, Italy, 06129
        • Not yet recruiting
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
        • Contact:
          • Phone Number: +39755783990
        • Principal Investigator:
          • PAOLO SPORTOLETTI
      • Rome, Italy, 00138
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Principal Investigator:
          • LUCA LAURENTI
        • Contact:
          • Phone Number: +390630156016
      • Terni, Italy, 05100
        • Not yet recruiting
        • Azienda Ospedaliera S. Maria Di Terni
        • Principal Investigator:
          • Arcangelo Liso
        • Contact:
          • Phone Number: +39744205971
  • Japan
      • Isehara, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital
        • Principal Investigator:
          • Yoshiaki Ogawa
        • Contact:
          • Phone Number: 81120023812
  • Poland
      • Brzozów, Poland, 36-200
        • Not yet recruiting
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
        • Contact:
          • Phone Number: +48134309728
        • Principal Investigator:
          • Jacek Krzanowski
      • Bydgoszcz, Poland, 85-168
        • Not yet recruiting
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
        • Principal Investigator:
          • Marta Sobas
        • Contact:
          • Phone Number: +48795149026
      • Katowice, Poland, 40-519
        • Not yet recruiting
        • Pratia Onkologia Katowice
        • Principal Investigator:
          • Sebastian Grosicki
        • Contact:
          • Phone Number: +48600388282
  • Spain
      • Santander, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Phone Number: +34942202520
        • Principal Investigator:
          • LUCRECIA YANEZ SAN SEGUNDO
      • Seville, Spain, 41010
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocío
        • Principal Investigator:
          • Fatima de la Cruz Vicente
        • Contact:
          • Phone Number: +34955013277
  • United Kingdom
      • Hull, United Kingdom, HU16 5JQ
        • Not yet recruiting
        • Castle Hill Hospital
        • Principal Investigator:
          • David Allsup
        • Contact:
          • Phone Number: +441482461296
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Principal Investigator:
          • Talha Munir
        • Contact:
          • Phone Number: +441132433144
      • Newmarket, United Kingdom, CB8 7XN
        • Not yet recruiting
        • Genesiscare
        • Principal Investigator:
          • George Follows
        • Contact:
          • Phone Number: +44 1223 816789
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • Recruiting
        • Mitchell Cancer Institute
        • Contact:
          • Phone Number: 334-660-5108
        • Principal Investigator:
          • Anita Mazloom
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Not yet recruiting
        • Arizona Oncology Associates, P.C. - HOPE
        • Principal Investigator:
          • Sudhir Manda
        • Contact:
          • Phone Number: 520-886-0206
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cancer Specialists, LLC
        • Contact:
          • Phone Number: 904-538-4488
        • Principal Investigator:
          • Ayed Ayed
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
        • Contact:
          • Phone Number: 612-884-6300
        • Principal Investigator:
          • Avina Singh
    • New York
      • Ithaca, New York, United States, 14850
        • Not yet recruiting
        • Cayuga Cancer Center
        • Principal Investigator:
          • Cynthia Davis
      • New York, New York, United States, 10065-6007
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
        • Contact:
          • Phone Number: 646-608-4273
        • Principal Investigator:
          • Prioty Islam
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Not yet recruiting
        • Oncology Hematology Care Inc
        • Contact:
          • Phone Number: 513-751-2273
        • Principal Investigator:
          • Kruti Patel
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Texas Oncology - Paris
        • Contact:
          • Phone Number: 214-370-1000
        • Principal Investigator:
          • Harris Naina
      • Kyle, Texas, United States, 78640
        • Not yet recruiting
        • US Oncology - Texas Oncology
        • Contact:
          • Phone Number: 210-595-5300
        • Principal Investigator:
          • David Friedman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • This is not applicable to this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pirtobrutinib (Arm A)
Participants receive pirtobrutinib orally
Drug: Pirtobrutinib
Administered orally
Other Names:
  • LY3527727
Experimental: Idelalisib (Arm B)
Participants receive idelalisib orally
Drug: Idelalisib
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27296
  • J2N-MC-JZNY (Other Identifier: Eli Lilly and Company)
  • J2N-MC-JZ03 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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