Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGPirtobrutinib
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with a Grade ≥3 treatment-emergent adverse events (TEAEs) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Time from Enrollment from the Originator Study until Death from Any Cause (Up to 93 Months) | Overall survival is defined as the time from enrollment from the originator study until death from any cause |
Countries
Australia, France, Italy, Japan, Poland, South Korea, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed