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RECRUITING
NCT06635681
PHASE2

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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

Interventions

DRUG

Daunorubicin

60mg/m2/d d1-3 in Induction therapy

DRUG

Cytarabine

Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy

DRUG

Venetoclax

100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment

DRUG

Azacitidine

75mg/m2/d d1-5

Locations (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China