Acute Myeloid Leukemia, Induction Chemotherapy
Conditions
Keywords
Decitabine, HAAG, AML
Brief 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.
Interventions
DRUGDecitabine 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;
DRUGIdarubicine plus Cytarabine regimen
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
Sponsors
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Day 28-35 of induction course | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | time from randomization to death from any cause |
| Leukemia-free survival (LFS) | 3 years | time from randomization to the first relapse or death |
| Cumulative incidence of relapse(CIR) | 3 years | time from achievement of a remmission to the first relapse |
| Number of adverse events | 2 years | adverse events are evaluated with CTCAE V5.0. |
Countries
China
Contacts
Primary ContactXiaowen Tang, Ph.D.
Backup ContactDepei Wu, Ph.D.
Outcome results
None listed