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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: chemotherapy (Aracytine + Daunorubicin)

• Registration Number: NCT00931138
• Lead Sponsor: Acute Leukemia French Association

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.

Study Timeline

• Status Verified: 1999-08
• Study Start: 1999-12
• Study Completion: 2006-12
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Last Update Submitted: 2009-06-30
• Study First Posted: 2009-07-02
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1 = Aracytine + Daunorubicin	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Arm 3 = Aracytine And Idarubicin	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Arm 2 = Aracytine And Idarubicin	chemotherapy (Aracytine + Daunorubicin)	Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Frequency and severity of adverse events

Trial Locations

Locations (9)

CH; 🇫🇷 Versailles, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

IGR; 🇫🇷 Villejuif, France

Hopital Percy; 🇫🇷 Clamart, France

Hopital Saint-Louis; 🇫🇷 Paris, France

Hopital Pitie-Salpetriere; 🇫🇷 Paris, France

CHU; 🇫🇷 Rouen, France

St Antoine Hospital; 🇫🇷 Paris, France

CNLCC; 🇫🇷 Saint-Cloud, France