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

The First Affiliated Hospital of Soochow University162 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Acute Myeloid Leukemia Induction Chemotherapy

Interventions

Decitabine plus HAAG regimenDRUG

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;

Idarubicine plus Cytarabine regimenDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. 2. Age 18-59. 3. ECOG score: 0-2. 4. Treatment related or secondary AML. 5. No history of previous chemotherapy or target therapy. 6. Provide informed consent. Exclusion Criteria: 1. Patients are pregnant or lactating. 2. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. 3. Patients with another malignant disease. 4. Patients with uncontrolled active infection. 5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL. 7. Patients with creatinine clearance rate \< 50ml/min. 8. Patients with active hepatitis B or hepatitis C infection. 9. Patients with HIV infection. 10. Patients with other commodities that the investigators considered not suitable for the enrollment.

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

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 frame: Day 28-35 of induction course

Secondary Outcomes

Overall survival (OS)

time from randomization to death from any cause

Time frame: 3 years

Leukemia-free survival (LFS)

time from randomization to the first relapse or death

Time frame: 3 years

Cumulative incidence of relapse(CIR)

time from achievement of a remmission to the first relapse

Time frame: 3 years

Number of adverse events

adverse events are evaluated with CTCAE V5.0.

Time frame: 2 years

Central Contacts

Xiaowen Tang, Ph.D.

CONTACT

(0086)51267780086 xwtang1020@163.com

Depei Wu, Ph.D.

CONTACT

(0086)51267780086 drwudepei@163.com

Data from ClinicalTrials.gov

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