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

NCT ID: NCT00931138

Last Updated: 2009-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2006-12-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm1 = Aracytine + Daunorubicin

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

Group Type: ACTIVE_COMPARATOR

chemotherapy (Aracytine + Daunorubicin)

Intervention Type: DRUG

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

Arm 3 = Aracytine And Idarubicin

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

Group Type: ACTIVE_COMPARATOR

chemotherapy (Aracytine + Daunorubicin)

Intervention Type: DRUG

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

Arm 2 = Aracytine And Idarubicin

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

Group Type: ACTIVE_COMPARATOR

chemotherapy (Aracytine + Daunorubicin)

Intervention Type: DRUG

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

Interventions

chemotherapy (Aracytine + Daunorubicin)

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

Intervention Type: DRUG

chemotherapy (Aracytine + Daunorubicin)

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

Intervention Type: DRUG

chemotherapy (Aracytine + Daunorubicin)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Acute Leukemia French Association

OTHER

Sponsor Role: lead

Responsible Party

CHV A. MIGNOT

Locations

CH

Caen, , France

Hopital Percy

Clamart, , France

CHU

Créteil, , France

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

CH

Roubaix, , France

CHU

Rouen, , France

CNLCC

Saint-Cloud, , France

CH

Valenciennes, , France

CH

Versailles, , France

IGR

Villejuif, , France

Countries

France

References

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Reference Type: DERIVED

PMID: 23749683 (View on PubMed)

Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terre C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

Reference Type: DERIVED

PMID: 23248249 (View on PubMed)

Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terre C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

Reference Type: DERIVED

PMID: 21459791 (View on PubMed)

Boissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.

Reference Type: DERIVED

PMID: 20625116 (View on PubMed)

Other Identifiers

ALFA 9801

Identifier Type: -

Identifier Source: org_study_id