Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232655
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-19
Brief Title:
Cladribine Venetoclax in Monocytic AML
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Study of CladribineVenetoclax After Failure of VenetoclaxHypomethylating Agent in Monocytic AML
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agentvenetoclax
Detailed Description:
This is an investigator-initiated open label single institution Study to assess the efficacy of CladVen following failure of HMAVen in AML with a monocytic phenotype In cycle 1 subjects will receive cladribine at a dose of 5mgm2 daily via intravenous infusion on days 1 through 5 and venetoclax 400mg daily following standard dose escalation over the first 3 days on days 1 through 28 of a 28 day cycle A bone marrow biopsy will be performed to assess response on day 28 of cycle 1 Subjects who respond to cycle 1 defined as achieving a CR CRi MLFS or PR per ELN criteria or a blast reduction of at least 50 from baseline may continue on alternating 28-day consolidation cycles of AzaVen even cycles and CladVen odd cycles Cycles will continue unless the subject needs to be removed from the study due to disease progression treatment failure defined as failure to achieve CR CRi or MLFS after 4 cycles of treatment intolerance or toxicity patient preference or other reasons
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?:
True
Is an FDA AA801 Violation?:
None