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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)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
chemotherapy (Aracytine + Daunorubicin)
chemotherapy (Aracytine + Daunorubicin)
chemotherapy (Aracytine + Daunorubicin)
Sponsored by
Acute Leukemia French Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia in adults, Newly-diagnosed untreated AML, Patient aged 50 to 70 years

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CH
  • Hopital Percy
  • CHU
  • CH
  • CHU
  • CH
  • Hopital Edouard Herriot
  • St Antoine Hospital
  • Hopital Pitie-Salpetriere
  • Hopital Saint-Louis
  • CH
  • CHU
  • CNLCC
  • CH
  • CH
  • IGR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm1 = Aracytine + Daunorubicin

Arm 3 = Aracytine And Idarubicin

Arm 2 = Aracytine And Idarubicin

Arm Description

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

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

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

Outcomes

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

Full Information

First Posted
June 29, 2009
Last Updated
June 30, 2009
Sponsor
Acute Leukemia French Association
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00931138
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Acute Leukemia French Association
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia in adults, Newly-diagnosed untreated AML, Patient aged 50 to 70 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (false)

8. Arms, Groups, and Interventions

Arm Title
Arm1 = Aracytine + Daunorubicin
Arm Type
Active Comparator
Arm Description
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Arm Title
Arm 3 = Aracytine And Idarubicin
Arm Type
Active Comparator
Arm Description
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Arm Title
Arm 2 = Aracytine And Idarubicin
Arm Type
Active Comparator
Arm Description
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Intervention Type
Drug
Intervention Name(s)
chemotherapy (Aracytine + Daunorubicin)
Intervention Description
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
Intervention Type
Drug
Intervention Name(s)
chemotherapy (Aracytine + Daunorubicin)
Intervention Description
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
Intervention Type
Drug
Intervention Name(s)
chemotherapy (Aracytine + Daunorubicin)
Intervention Description
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Frequency and severity of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CH
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHU
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CH
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CH
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
Country
France
Facility Name
St Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
Country
France
Facility Name
CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CNLCC
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
CH
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
CH
City
Versailles
Country
France
Facility Name
IGR
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23749683
Citation
Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terre C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.
Results Reference
derived
PubMed Identifier
23248249
Citation
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.
Results Reference
derived
PubMed Identifier
21459791
Citation
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.
Results Reference
derived
PubMed Identifier
20625116
Citation
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.
Results Reference
derived

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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

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