NCT02937662

Efficacy of Idarubicin, Cytarabine and Cyclophosphamide (IAC) Regimen in Relapsed/Refractory AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 0 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. In the experimental arm, patients receive IAC regimen. In the control arm, patients receive other physician-directed regimen. The primary end point is complete remission rate.

Detailed description

In this multi-center, randomized, open-label, prospective clinical trial, a total of 60 relapsed/refractory AML patients will be randomized into 2 groups. Patients in the IAC arm receive the therapy consisting of idarubicin 10 mg/㎡/d on days 1-3, cytarabine 100mg/㎡/d on days 1-7 and cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day. In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine plus daunorubicin(DA）regimen , decitabine,aclacinomycin and cytarabine(decitabine plus AA) regimen or AA regimen plus granulocyte stimulating factor. All the regimen in the control arm can not contain cyclophosphamide. The primary end point is complete remission. The second end points include overall survival, relapse-free survival and time to treatment failure.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Idarubicin	Idarubicin at a dose of 10 mg/㎡/d on days 1-3.
DRUG	Cytarabine	Cytarabine at a dose of 100mg/㎡/d on days 1-7.
DRUG	Cyclophosphamide	Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.
DRUG	Physician-Directed Regimens without Cyclophosphamide	Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2016-10-18
• Last updated: 2025-05-30

Locations

1 site across 1 country: China