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This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.

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;

Decitabine plus HAAG regimen

Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion

Idarubicine plus Cytarabine regimen

Xiaowen Tang, Ph.D.

Depei Wu, Ph.D.

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.

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.

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

ORR includes complete response (CR), CRi and PR. CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.

time from randomization to death from any cause

time from randomization to the first relapse or death

time from achievement of a remmission to the first relapse

adverse events are evaluated with CTCAE V5.0.

Second Affiliated Hospital of Soochow University

Changzhou No.2 People's Hospital

The First People's Hospital of Lianyungang

Jingjiang People's Hospital

Zhangjiagang First People's Hospital

The Second People's Hospital of Huai'an

The Third People's Hospital of Kunshan

The First Affiliated Hospital of Soochow University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients	NCT04087967	Acute Myeloid L... Induction Chemo...	Decitabine plus... Idarubicine plu...	18 Years - 59 Years	The First Affiliated Hospital of Soochow University
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients	NCT04087967	Acute Myeloid L... Induction Chemo...	Decitabine plus... Idarubicine plu...	18 Years - 59 Years	The First Affiliated Hospital of Soochow University

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