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Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients

NCT04087967 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-09-12

No results posted yet for this study

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 younger than 60 years.

Conditions

Interventions

DRUG

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;

DRUG

Idarubicine plus Cytarabine regimen

Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Changzhou No.2 People's Hospital

    collaborator OTHER

  • The First People's Hospital of Lianyungang

    collaborator OTHER

  • Jingjiang People's Hospital

    collaborator OTHER

  • Zhangjiagang First People's Hospital

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The Third People's Hospital of Kunshan

    collaborator UNKNOWN

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Xiaowen Tang, Ph.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-05-31
Completion
2022-05-31

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 NCT04087967 on ClinicalTrials.gov