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

Soochow University

Status and phase: Unknown; Phase 3

Conditions: Induction Chemotherapy; Acute Myeloid Leukemia

Treatments: Drug: Decitabine plus HAAG regimen; Drug: Idarubicine plus Cytarabine regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT04087967

DAC-HAAG-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Decitabine combined with HAAG

Experimental group

Description:

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

Treatment:

Drug: Decitabine plus HAAG regimen

IA Regimen

Active Comparator group

Description:

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

Treatment:

Drug: Idarubicine plus Cytarabine regimen