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A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

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ClinicalTrials.gov Identifier: NCT00927498
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : July 11, 2013
Sponsor:
Collaborator:
Versailles Hospital
Information provided by (Responsible Party):
Acute Leukemia French Association

Study Description
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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 doses.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: conventional chemotherapy (AraC + Daunorubicin), Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), Phase 3

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 centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A Daunorubicin and Cytarabine

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

 Drug: conventional chemotherapy (AraC + Daunorubicin),

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.
Experimental: Arm B Daunorubicin and Cytarabine and Mylotarg

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.

 Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: Relapse or death measured from randomization ]

Secondary Outcome Measures :
  1. CR rate [ Time Frame: CR after induction ]
  2. Cumulative incidence of relapse [ Time Frame: Relapse from CR ]
  3. Overall Survival [ Time Frame: Survival from randomization ]
  4. Safety of the combination Mylotarg+chemotherapy [ Time Frame: Duration of study ]
  5. Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM) [ Time Frame: Duration of study ]
  6. Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. [ Time Frame: Duration of study ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927498


Locations
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Sponsors and Collaborators
Acute Leukemia French Association
Versailles Hospital
Investigators
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Principal Investigator: Castaigne Sylvie, Professor Versailles Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Acute Leukemia French Association
ClinicalTrials.gov Identifier: NCT00927498    
Other Study ID Numbers: ALFA 0701
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Acute Leukemia French Association:
Acute myeloid Leukemia
patient aged 50 to 70 years
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Cytarabine
Daunorubicin
Gemtuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents