NCT04083911

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

A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Elderly Newly Diagnosed Acute Myeloid Leukemia Patients.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 60 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Induction Chemotherapy

Interventions

Type	Name	Description
DRUG	Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF	Decitabine:20mg/m2/d, d1\~5, intravenous infusion; Homoharringtonine:1mg/d,d3\~9,intravenous infusion; Aclarubicin:10mg/d, d3\~d6, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-9, subcutaneous injection; Granulocyte colony-stimulating factor: 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-05-31
• Completion: 2022-05-31
• First posted: 2019-09-10
• Last updated: 2019-09-10

Locations

1 site across 1 country: China