NCT04087967

Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients

A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.

Detailed description

This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.

Conditions

• Acute Myeloid Leukemia
• Induction Chemotherapy

Interventions

Type	Name	Description
DRUG	Decitabine plus HAAG regimen	Decitabine:20mg/m2/d,d1\~5, intravenous infusion; Homoharringtonine:1mg/d,d3\~16,intravenous infusion; Aclarubicin:10mg/d, d3\~d10, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;
DRUG	Idarubicine plus Cytarabine regimen	Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-05-31
• Completion: 2022-05-31
• First posted: 2019-09-12
• Last updated: 2019-09-12

Locations

1 site across 1 country: China