Idarubicin Plus Cytarabine (IA) vs IA Plus Cladribine (IAC) as Induction Regimen to Treat Initially Diagnosed Acute Myeloid Leukemia (AML)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2022
  • participants needed
    840
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 24 January 2021
cytarabine
induction chemotherapy
idarubicin
ara-c
cladribine

Summary

The purpose of this study is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed AML patients. 840 cases are supposed to recruited in 3 years.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment IAC regimen, High-dose IA regimen, Intermediate-dose IA regimen
Clinical Study IdentifierNCT02323022
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Initially diagnosed as AML (except APL)
Aged between 18 and 60 year old
Eastern Cooperative Oncology Group (ECOG) score no more than 3
Informed consent file (ICF) signed

Exclusion Criteria

AML secondary to chronic leukemia and myeloproliferative disease (MPD)
APL
With underlying malignancies except AML
Uncontrolled severe infection
Intolerant to chemotherapy organically including
Heart failure: ejection fraction (EF) less than 30%, and New York Heart Association (NYHA) grading high than Grade II
Liver and kidney dysfunction: serum bilirubin2mg/dl, AST2.5upper limit of normal (ULN), serum creatine2.5mg/dl
Refuse to participate the trial
Clear my responses

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