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ACTIVE NOT RECRUITING
NCT03021330
PHASE3

Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.

Key Details

Gender

All

Age Range

14 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1100

Start Date

2017-02-08

Completion Date

2027-10-15

Last Updated

2025-05-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Daunomycin and Cytarabine (DA Regimen)

Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.

DRUG

Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)

Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China