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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Cladribine; Idarubicin

Criteria

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 bilirubin≥2mg/dl, AST≥2.5*upper limit of normal (ULN), serum creatine≥2.5mg/dl

• Refuse to participate the trial