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 (ALFA 9801)

Acute Leukemia French Association

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: chemotherapy (Aracytine + Daunorubicin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00931138

ALFA 9801

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 3 patient groups

Arm1 = Aracytine + Daunorubicin

Active Comparator group

Description:

Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3

Treatment:

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)

Arm 3 = Aracytine And Idarubicin

Active Comparator group

Description:

Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4

Treatment:

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)

Arm 2 = Aracytine And Idarubicin

Active Comparator group

Description:

Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3

Treatment:

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)

Drug: chemotherapy (Aracytine + Daunorubicin)