Recruiting

Pirtobrutinib

Sponsor:

Eli Lilly and Company

Code:

NCT07218341

Conditions

Chronic Lymphocytic Leukemia

Lymphoma, Small Lymphocytic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pirtobrutinib

Idelalisib

Study Details

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.

Conditions

Chronic Lymphocytic Leukemia

Lymphoma, Small Lymphocytic

Study ID

NCT07218341

Start date

Mar 9, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • This is not applicable to this study

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pirtobrutinib (Arm A)

Participants receive pirtobrutinib orally

experimental: Idelalisib (Arm B)

Participants receive idelalisib orally

Interventions

Pirtobrutinib

Administered orally

Idelalisib

Administered orally

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36693

Contacts

334-660-5108

Principal Investigator:

Anita Mazloom

Cancer Specialists, LLC

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

904-538-4488

Principal Investigator:

Ayed Ayed

Minnesota Oncology Hematology, P.A.

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

612-884-6300

Principal Investigator:

Avina Singh

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

Recruiting

New York, New York, United States, 10065-6007

Contacts

646-608-4273

Principal Investigator:

Prioty Islam

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.