NCT07514936

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Newly Diagnosed Acute Myeloid Leukemia (AML)
• Elderly Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-12-30
• Completion: 2027-12-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China