Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557421
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
STOP VEN
Brief Summary:
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE VEN-AZA de-escalation strategy in Acute Myeloid Leukemia responding patients The main objectives of the study are
Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival
Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria
Participants will
Stop VEN-DASA treatment
Be closely monitored by regular evaluation of the disease
Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival
Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria
Participants will
Stop VEN-DASA treatment
Be closely monitored by regular evaluation of the disease
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