Acute Myeloid Leukemia Clinical Trial
Official title:
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.
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 doses.
Status | Completed |
Enrollment | 280 |
Est. completion date | July 2013 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CH | Argenteuil | |
France | Hopital Avicenne | Bobigny | |
France | CH | Caen | |
France | Hopital Percy | Clamart | |
France | CHU | Creteil | |
France | CHU | Dijon | |
France | CH | Lens | |
France | CHU | Lille | |
France | CH | Limoges | |
France | Hopital Edouard Herriot | Lyon | |
France | CH | Meaux | |
France | Hopital Pitie-Salpetriere | Paris | |
France | Hopital Saint-Louis | Paris | |
France | CH | Roubaix | |
France | CHU | Rouen | |
France | CNLCC | Saint-Cloud | |
France | CH | Valenciennes | |
France | Hospital Central | Versailles | |
France | IGR | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Acute Leukemia French Association | Central Hospital, Versailles |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Free Survival (EFS) | Relapse or death measured from randomization | No | |
Secondary | CR rate | CR after induction | Yes | |
Secondary | Cumulative incidence of relapse | Relapse from CR | No | |
Secondary | Overall Survival | Survival from randomization | No | |
Secondary | Safety of the combination Mylotarg+chemotherapy | Duration of study | Yes | |
Secondary | Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM) | Duration of study | No | |
Secondary | Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. | Duration of study | No |
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