NCT02323022

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	IAC regimen	Induction treatment for initially diagnosed AML with IAC regimen, including Cladribine 5mg/msq/d (d1-5), Ara-C 100mg/msq/d(d1-7) and IDA 8mg/msq/d (d1-3)
DRUG	IA regimen	Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-03-01
• Completion: 2022-01-01
• First posted: 2014-12-23
• Last updated: 2024-07-30

Locations

1 site across 1 country: China