Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60

Soochow University

Status and phase: Unknown; Phase 3

Conditions: Induction Chemotherapy; Acute Myeloid Leukemia

Treatments: Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT04083911

DAC-HAAG-02

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 older than 60 years.

Full description

This is a phase 3, open Label, single arm, multi-center study in elderly newly diagnosed AML patients. The patients will receive DAC combined with HAAG in the induction treatment.

Enrollment: 50 estimated patients

Sex: All

Ages: 60 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
2. 60-79 years old.
3. ECOG score: 0-3.
4. No history of previous chemotherapy or target therapy.
5. Provide informed consent.

Exclusion criteria

1. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
2. Patients with another malignant disease.
3. Patients with uncontrolled active infection.
4. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
6. Patients with creatinine clearance rate < 50ml/min.
7. Patients with active hepatitis B or hepatitis C infection.
8. Patients with HIV infection.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Decitabine combined with HAAG Regimen

Experimental group

Description:

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

Treatment:

Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF