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

Acute Myeloid Leukemia Clinical Trial

— ALFA 9801  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931138
• Other study ID #: ALFA 9801
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2009
• Last updated: June 30, 2009
• Start date: December 1999
• Est. completion date: December 2006

Study information

• Verified date: August 1999
• Source: Acute Leukemia French Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
• chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
• chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4

Locations

Country	Name	City	State
France	CH	Caen
France	Hopital Percy	Clamart
France	CHU	Creteil
France	CH	Lens
France	CHU	Lille
France	CH	Limoges
France	Hopital Edouard Herriot	Lyon
France	Hopital Pitie-Salpetriere	Paris
France	Hopital Saint-Louis	Paris
France	St Antoine Hospital	Paris
France	CH	Roubaix
France	CHU	Rouen
France	CNLCC	Saint-Cloud
France	CH	Valenciennes
France	CH	Versailles
France	IGR	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Acute Leukemia French Association	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency and severity of adverse events			Yes