Clinical trial NCT04087967: Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Induction Chemotherapy
Keywords: Decitabine
HAAG
AML
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
name: Changzhou No.2 People's Hospital
name: The First People's Hospital of Lianyungang
name: Jingjiang People's Hospital
name: Zhangjiagang First People's Hospital
name: The Second People's Hospital of Huai'an
name: The Third People's Hospital of Kunshan
First posted: 2019-09-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Day 28-35 of induction course
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Leukemia-free survival (LFS)
timeFrame: 3 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 3 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: