Status:
UNKNOWN
Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Second Affiliated Hospital of Soochow University
Changzhou No.2 People's Hospital
Conditions:
Acute Myeloid Leukemia
Induction Chemotherapy
Eligibility:
All Genders
60-79 years
Phase:
PHASE3
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 older than 60 years.
Detailed 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.
Eligibility Criteria
Inclusion
- Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- 60-79 years old.
- ECOG score: 0-3.
- No history of previous chemotherapy or target therapy.
- Provide informed consent.
Exclusion
- Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
- Patients with another malignant disease.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
- Patients with creatinine clearance rate \< 50ml/min.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04083911
Start Date
April 1 2019
End Date
May 31 2022
Last Update
September 10 2019
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006