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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
CH
Caen, France
Hopital Percy
Clamart, France
CHU
Créteil, France
To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
Frequency and severity of adverse events
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CH
Lens, France
CHU
Lille, France
CH
Limoges, France
Hopital Edouard Herriot
Lyon, France
St Antoine Hospital
Paris, France
Hopital Pitie-Salpetriere
Paris, France
Hopital Saint-Louis
Paris, France
...and 6 more locations