Status:
COMPLETED
A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
Lead Sponsor:
Acute Leukemia French Association
Collaborating Sponsors:
Versailles Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
50-70 years
Phase:
PHASE3
Brief Summary
The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided dose...
Detailed Description
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 centrali...
Eligibility Criteria
Inclusion
- 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
- M3-AML
- AML following previously know myeloproliferative syndrome.
- Known central nervous system involvement.
- Uncontrolled infection
- Other active malignancy
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00927498
Start Date
December 1 2007
End Date
July 1 2013
Last Update
July 11 2013
Active Locations (19)
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1
CH
Argenteuil, France, 95107
2
Hopital Avicenne
Bobigny, France, 93309
3
CH
Caen, France, 14033
4
Hopital Percy
Clamart, France, 92141