Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
NCT ID: NCT04087967
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
162 participants
INTERVENTIONAL
2019-04-01
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Decitabine combined with HAAG
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
Decitabine 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;
IA Regimen
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
Idarubicine plus Cytarabine regimen
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
Interventions
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Decitabine 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;
Idarubicine plus Cytarabine regimen
Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
59 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Changzhou No.2 People's Hospital
OTHER
The First People's Hospital of Lianyungang
OTHER
Jingjiang People's Hospital
OTHER
Zhangjiagang First People's Hospital
OTHER
The Second People's Hospital of Huai'an
OTHER
The Third People's Hospital of Kunshan
UNKNOWN
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Xiaowen Tang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DAC-HAAG-01
Identifier Type: -
Identifier Source: org_study_id
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