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RECRUITING
NCT07514936
PHASE2

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.

Official title: Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-11-18

Completion Date

2027-12-31

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

the standard "3+7" regimen

IA Regimen: Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.

DRUG

Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte

IA Regimen: Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or DA Regimen: Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7. Or MA Regimen: Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.

Locations (1)

Chinese PLA General Hospital

Beijing, None Selected, China