A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.
50 Years
70 Years
Both
Acute Myeloid Leukemia
Trial Information
A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.
Patients with a morphologically proven diagnosis AML and both the two following criteria:
- Age > 50 years and £ 70 years.
- Not previously treated for their disease.
Randomization will be centralized by phone :
Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and
Mylotarg.
Inclusion Criteria:
- Patients with a morphologically proven diagnosis AML and both the two following
criteria: Age > 50 years and £ 70 years. Not previously treated for their disease.
- ECOG performance status 0 to 3
- Negative serology HIV, HBV and HBC (except post vaccination)
- Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N
- Cardiac function determined by radionucleide or echography within normal limits.
- Negative serum pregnancy test within one week before treatment for women of child
bearing potential.
- Signed informed consent.
Exclusion Criteria:
- M3-AML
- AML following previously know myeloproliferative syndrome.
- Known central nervous system involvement.
- Uncontrolled infection
- Other active malignancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event Free Survival (EFS)
Outcome Time Frame:
Relapse or death measured from randomization
Safety Issue:
No
Principal Investigator
Castaigne Sylvie, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Central Hospital, Versailles
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ALFA 0701
NCT ID:
NCT00927498
Start Date:
December 2007
Completion Date:
January 2010
Related Keywords:
- Acute Myeloid Leukemia
- Acute myeloid Leukemia
- patient aged 50 to 70 years
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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