Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04965493
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-07-15
Brief Title:
A Trial of Pirtobrutinib LOXO-305 Plus Venetoclax and Rituximab PVR Versus Venetoclax and Rituximab VR in Previously Treated Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL
Sponsor:
Loxo Oncology Inc
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 3 Open-Label Randomized Study of Fixed Duration Pirtobrutinib LOXO-305 Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma BRUIN CLL-322
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRUIN CLL-322
Brief Summary:
The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib LOXO-305 with VR Arm A compared to VR alone Arm B in patients with CLLSLL who have been previously treated with at least one prior line of therapy Participation could last up to five years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| J2N-OX-JZNO | OTHER | Eli Lilly and Company | None |