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Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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.
Official title: Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial
Key Details
Gender
All
Age Range
14 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2024-09-29
Completion Date
2028-10-01
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Daunorubicin
60mg/m2/d d1-3 in Induction therapy
Cytarabine
Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
Venetoclax
100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
Azacitidine
75mg/m2/d d1-5
Locations (1)
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China