Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429098
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-14
Brief Title:
Study of A Venetoclax-based Anthracycline-free Regimen in Newly Diagnosed CBFβMYH11 AML
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
Study of A Venetoclax-based Anthracycline-free Regimen in Patients With Newly Diagnosed CBFβMYH11-positive Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2023-12
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:
This investigator-initiated single-arm phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based anthracycline-free regimen in patients with newly diagnosed CBFβMYH11-positive acute myeloid leukemia
Detailed Description:
Primary Objectives
To determine the CR complete remission CRi complete remission with incomplete blood count recovery rate of 2 cycles of VENHMA in patients with newly diagnosed ND CBFβMYH11-positive acute myeloid leukemiaAML
Secondary Objectives
1 To determine the overall response rate ORR of 2 cycles of VENHMA in patients with ND CBFβMYH11-positive AML
2 To determine the safety of the combination regimen
3 To study the trajectories of molecular measurable residual disease MRD during the therapy
4 To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen
5 To assess the duration of response overall survival OS and event free survival EFS of patients
OUTLINE
INDUCTION
Patients with newly diagnosed CBFβMYH11 AML receive 2 cycles of VENHMA as induction therapy Venetoclax orally PO once daily QD on days 1-28 azacitidine subcutaneously SC on days 1-7 or decitabine intravenously IV over 30-60 minutes on days 1-5
CONSOLIDATION
Patient fitness will be reassessed according to the Ferrara criteria if CR or CRi is achieved after 2 cycles of VENHMA Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine 2gm2 every 12 hours on days 1-3 combined with venetoclax on days 1-7 Unfit patients will continue to receive VENHMA until disease progression
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
To determine the CR complete remission CRi complete remission with incomplete blood count recovery rate of 2 cycles of VENHMA in patients with newly diagnosed ND CBFβMYH11-positive acute myeloid leukemiaAML
Secondary Objectives
1 To determine the overall response rate ORR of 2 cycles of VENHMA in patients with ND CBFβMYH11-positive AML
2 To determine the safety of the combination regimen
3 To study the trajectories of molecular measurable residual disease MRD during the therapy
4 To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen
5 To assess the duration of response overall survival OS and event free survival EFS of patients
OUTLINE
INDUCTION
Patients with newly diagnosed CBFβMYH11 AML receive 2 cycles of VENHMA as induction therapy Venetoclax orally PO once daily QD on days 1-28 azacitidine subcutaneously SC on days 1-7 or decitabine intravenously IV over 30-60 minutes on days 1-5
CONSOLIDATION
Patient fitness will be reassessed according to the Ferrara criteria if CR or CRi is achieved after 2 cycles of VENHMA Fit patients will receive four cycles of consolidation therapy with high-dose cytarabine 2gm2 every 12 hours on days 1-3 combined with venetoclax on days 1-7 Unfit patients will continue to receive VENHMA until disease progression
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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