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

Soochow University

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: IA regimen; Drug: IAC regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT02323022

SZ3202

Details and patient eligibility

About

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

Enrollment: 618 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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618 participants in 2 patient groups

IAC regimen

Experimental group

Description:

Receive IAC induction therapy

Treatment:

Drug: IAC regimen

IA regimen

Active Comparator group

Description:

Receive an IA induction therapy

Treatment:

Drug: IA regimen