A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06876662
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pirtobrutinib — DRUGAdministered orally.
Study Details
Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.
Key Dates
- Start date
- May 20, 2025
- Status verified
- Feb 2026
- Primary completion
- May 31, 2030
- Completion
- Dec 31, 2032
Study Design
- Enrollment
- 279 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: JZ01 PirtobrutinibParticipants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
Primary Outcome Measure
Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs) [ Time Frame: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a 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 (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136-1002 | 954-265-6549 Alvaro Alencar (PRINCIPAL_INVESTIGATOR) |
| Florida Cancer Specialists | Sarasota | Florida | 34232-6422 | 941-377-9993 Manish Patel (PRINCIPAL_INVESTIGATOR) |
| The Emory Clinic | Atlanta | Georgia | 30322-1013 | 404-778-3708 Jonathon Cohen (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611-3013 | 312-908-5250 Shuo Ma (PRINCIPAL_INVESTIGATOR) |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | 617-632-5847 Jennifer Brown (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic- Minnesota | Rochester | Minnesota | 55905 | 507-284-2511 Yucai Wang (PRINCIPAL_INVESTIGATOR) |
| University Of Nebraska Medical Center | Omaha | Nebraska | 69198 | 402-559-5166 Matthew Lunning (PRINCIPAL_INVESTIGATOR) |
| Cayuga Cancer Center | Ithaca | New York | 14850 | - |
| Northwell Health | Lake Success | New York | 11042-1118 | 516-734-8959 Steven Allen (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065-6007 | 646-608-4273 Prioty Islam (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan-Kettering Cancer Center (MSKCC) - New York | New York | New York | 10065-6007 | - |
| Duke University Medical Center | Durham | North Carolina | 27710-4000 | 919-684-8111 Matthew McKinney (PRINCIPAL_INVESTIGATOR) |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1063 | 614-293-3196 Jennifer Woyach (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | 215-662-3933 Sunita Nasta (PRINCIPAL_INVESTIGATOR) |
| Tennessee Oncology | Nashville | Tennessee | 37203-2659 | 615-524-4074 Michael Byrne (PRINCIPAL_INVESTIGATOR) |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4000 | 713-792-2860 Michael Wang (PRINCIPAL_INVESTIGATOR) |
| Swedish Cancer Institute | Seattle | Washington | 98104-3588 | 908-208-4685 Swathi Namburi (PRINCIPAL_INVESTIGATOR) |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3548 | 414-805-4600 Nirav Shah (PRINCIPAL_INVESTIGATOR) |
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