Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524375
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Brutons Tyrosine Kinase Inhibitor cBTKi for First-Line Chronic Lymphocytic Leukemia 1L CLL to Achieve Deep Durable Remissions to Allow Off-Treatment Period
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Open-Label Prospective Single-Arm Multi-Center Clinical Trial to Evaluate if Adding Venetoclax to Patients on Covalent BTKi For 1L CLL Can Achieve Deep Durable Remissions by UMRD 10-4 to Allow Off-Treatment Period
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVE
Brief Summary:
The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease uMRD or 10-4 in peripheral blood PB by end of combination treatment EOCT to allow off-treatment period
The acronym BRAVE stands for Btki Responders to Achieve deep remission or off-treatment periods with VEnetoclax
The acronym BRAVE stands for Btki Responders to Achieve deep remission or off-treatment periods with VEnetoclax
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None