A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Purpose

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.

Conditions

  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Are currently enrolled and active in the originator study, LOXO-BTK-18001. A participant is considered active in the study if they are: - receiving study intervention - in the short-term follow-up period, or - in the long-term follow-up period

Exclusion Criteria

  • Were a participant in the Phase 1b cohort of Study LOXO-BTK-18001

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JZ01 Pirtobrutinib 		Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA). Pirtobrutinib administered orally.
  • Drug: Pirtobrutinib
    Administered orally.
    Other names:
    • LOXO-305
    • LY3527727

Recruiting Locations

Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136-1002
Contact:
954-265-6549

Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232-6422
Contact:
941-377-9993

The Emory Clinic
Atlanta 4180439, Georgia 4197000 30322-1013
Contact:
404-778-3708

Northwestern University
Chicago 4887398, Illinois 4896861 60611-3013
Contact:
312-908-5250

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02115
Contact:
617-632-5847

Mayo Clinic- Minnesota
Rochester 5043473, Minnesota 5037779 55905
Contact:
507-284-2511

University Of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 69198
Contact:
402-559-5166

Cayuga Cancer Center
Ithaca 5122432, New York 5128638 14850
Contact:
607-272-5414

Northwell Health
Lake Success 5123853, New York 5128638 11042-1118
Contact:
516-734-8959

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York 5128581, New York 5128638 10065-6007
Contact:
646-608-4273

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York 5128581, New York 5128638 10065-6007

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710-4000
Contact:
919-684-8111

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210-1063
Contact:
614-293-3196

University of Pennsylvania Hospital
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
215-662-3933

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203-2659
Contact:
615-524-4074

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-4000
Contact:
713-792-2860

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104-3588
Contact:
908-208-4685

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226-3548
Contact:
414-805-4600

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com