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 — DRUG
    Administered 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 Pirtobrutinib
    Participants 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) or
    1-317-615-4559
  • Physicians interested in becoming principal investigators please contact

Locations (18)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-1002
954-265-6549
Alvaro Alencar (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232-6422
941-377-9993
Manish Patel (PRINCIPAL_INVESTIGATOR)
The Emory ClinicAtlantaGeorgia30322-1013
404-778-3708
Jonathon Cohen (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611-3013
312-908-5250
Shuo Ma (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
617-632-5847
Jennifer Brown (PRINCIPAL_INVESTIGATOR)
Mayo Clinic- MinnesotaRochesterMinnesota55905
507-284-2511
Yucai Wang (PRINCIPAL_INVESTIGATOR)
University Of Nebraska Medical CenterOmahaNebraska69198
402-559-5166
Matthew Lunning (PRINCIPAL_INVESTIGATOR)
Cayuga Cancer CenterIthacaNew York14850-
Northwell HealthLake SuccessNew York11042-1118
516-734-8959
Steven Allen (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007
646-608-4273
Prioty Islam (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007-
Duke University Medical CenterDurhamNorth Carolina27710-4000
919-684-8111
Matthew McKinney (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1063
614-293-3196
Jennifer Woyach (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
215-662-3933
Sunita Nasta (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203-2659
615-524-4074
Michael Byrne (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030-4000
713-792-2860
Michael Wang (PRINCIPAL_INVESTIGATOR)
Swedish Cancer InstituteSeattleWashington98104-3588
908-208-4685
Swathi Namburi (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226-3548
414-805-4600
Nirav Shah (PRINCIPAL_INVESTIGATOR)

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