NCT00931138

Treatment of Acute Myeloid Leukemia (AML) in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 2

Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (planned)
• Sponsor: Acute Leukemia French Association · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

Detailed description

Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
DRUG	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
DRUG	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4

Timeline

• Start date: 1999-12-01
• Completion: 2006-12-01
• First posted: 2009-07-02
• Last updated: 2009-07-02

Locations

16 sites across 1 country: France