A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT07218341
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Chronic Lymphocytic Leukemia
- Lymphoma, Small Lymphocytic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pirtobrutinib — DRUGAdministered orally
- Idelalisib — DRUGAdministered orally
Study Details
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.
Key Dates
- Start date
- Mar 9, 2026
- Status verified
- May 2026
- Primary completion
- May 31, 2030
- Completion
- Dec 31, 2032
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pirtobrutinib (Arm A)Participants receive pirtobrutinib orally
- Experimental: Idelalisib (Arm B)Participants receive idelalisib 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
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mitchell Cancer Institute | Mobile | Alabama | 36693 | 334-660-5108 Anita Mazloom (PRINCIPAL_INVESTIGATOR) |
| Arizona Oncology Associates, P.C. - HOPE | Tucson | Arizona | 85711 | 520-886-0206 Sudhir Manda (PRINCIPAL_INVESTIGATOR) |
| Cancer Specialists, LLC | Jacksonville | Florida | 32256 | 904-538-4488 Ayed Ayed (PRINCIPAL_INVESTIGATOR) |
| Minnesota Oncology Hematology, P.A. | Coon Rapids | Minnesota | 55433 | 612-884-6300 Avina Singh (PRINCIPAL_INVESTIGATOR) |
| Cayuga Cancer Center | Ithaca | New York | 14850 | Cynthia Davis (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065-6007 | 646-608-4273 Prioty Islam (PRINCIPAL_INVESTIGATOR) |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45211 | 513-751-2273 Kruti Patel (PRINCIPAL_INVESTIGATOR) |
| Texas Oncology - Paris | Fort Worth | Texas | 76104 | 214-370-1000 Harris Naina (PRINCIPAL_INVESTIGATOR) |
| US Oncology - Texas Oncology | Kyle | Texas | 78640 | 210-595-5300 David Friedman (PRINCIPAL_INVESTIGATOR) |
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