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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)

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Acute Leukemia French Association
ClinicalTrials.gov Identifier:
NCT00931138
First received: June 29, 2009
Last updated: June 30, 2009
Last verified: August 1999
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukemia
 Drug: chemotherapy (Aracytine + Daunorubicin)
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acute Leukemia French Association:

Primary Outcome Measures:
  • 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:
  • Frequency and severity of adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 420
Study Start Date: December 1999
Estimated Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: Arm1 = Aracytine + Daunorubicin
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
 Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Active Comparator: Arm 3 = Aracytine And Idarubicin
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
 Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Active Comparator: Arm 2 = Aracytine And Idarubicin
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
 Drug: chemotherapy (Aracytine + Daunorubicin)
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931138

Locations
France
CH
Caen, France, 14033
Hopital Percy
Clamart, France, 92141
CHU
Creteil, France, 94010
CH
Lens, France, 62307
CHU
Lille, France, 59037
CH
Limoges, France, 87042
Hopital Edouard Herriot
Lyon, France
St Antoine Hospital
Paris, France, 75012
Hopital Saint-Louis
Paris, France
Hopital Pitie-Salpetriere
Paris, France, 75651
CH
Roubaix, France, 59100
CHU
Rouen, France, 76038
CNLCC
Saint-Cloud, France, 92210
CH
Valenciennes, France, 59322
CH
Versailles, France
IGR
Villejuif, France, 94805
Sponsors and Collaborators
Acute Leukemia French Association
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Acute Leukemia French Association

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr Sylvie Castaigne - Pricipal Investigator, CHV A. MIGNOT
ClinicalTrials.gov Identifier: NCT00931138     History of Changes
Other Study ID Numbers: ALFA 9801
Study First Received: June 29, 2009
Last Updated: June 30, 2009
Health Authority: France: Ministry of Health

Keywords provided by Acute Leukemia French Association:
Acute Myeloid Leukemia in adults
Newly-diagnosed untreated AML
Patient aged 50 to 70 years

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 16, 2013