Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635681
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia a Multi-center Single-arm Clinical Trial
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:
DAV-AML-2024
Brief Summary:
Acute myeloid leukemia AML is a common hematological malignancy Intensive chemotherapy is the main treatment in fit patients
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival
Since AML is a highly heterogeneous disease it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy
Therefore this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival
Since AML is a highly heterogeneous disease it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy
Therefore this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups
Detailed Description:
Patients will receive 1 course of intensive chemotherapy combined with venetoclax for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine combined with Venetoclax for consolidation After consolidation therapy Venetoclax in combination with azacitidine will be applied for 6 courses as maintenance treatment Allogeneic hematopoietic stem cell transplantation is recommended for high-risk groups and intermediate-risk with positive measurable residual disease
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