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Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML

NCT03021330 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-05-30

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Jianxiang Wang, Dr · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2026-05-15
Completion
2027-10-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021330 on ClinicalTrials.gov