Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia in adults, Newly-diagnosed untreated AML, Patient aged 50 to 70 years
Brief 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.
Interventions
DRUGchemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Sponsors
Assistance Publique - Hôpitaux de Paris
Acute Leukemia French Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient from 50 to 70 years * AML de Novo * No prior therapy for AML * Absence of severe infection (WHO grade greater than 2), independent of the AML * Cardiac function determined by radionucleotide or echography within normal limits. * total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N * ECOG performance status 0 to 3 * Signed informed consent.
Exclusion criteria
* M3-AML * history of neoplasia treated by radiotherapy or chemotherapy * Myelodysplasia diagnosed more than 6 months before the diagnosis of AML * Prior treatment for AML * Uncontrolled infection * Other active malignancy * Patient unable to undergo regular surveillance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events | — |
Countries
France
Outcome results
None listed