IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial

SZ3202

The goal of this clinical trial is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed acute myeloid leukemia (AML) patients. The main question it aims to answer is: •Does IAC regimen higher the complete remission rate in initial diagnosed AML patients? Researchers will compare IAC regimen to IA regimen to see if IAC works to treat AML. Participants will: * Receive IAC or IA as induction regimen * Receive a second cycle of re-induction if partial remission * Visit the clinic once every 3 to 6 months for assessment

2014-12-01

2020-01-01

2022-01-01

Completed

Early phase I

618

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 neoplasms (MPNs) * With other underlying malignancies * Severe and uncontrolled infection * Intolerant to the chemotherapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 618, 'type': 'ACTUAL'}}

2024-05-20