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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Acute Leukemia French Association.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Central Hospital, Versailles
Information provided by:
Acute Leukemia French Association
ClinicalTrials.gov Identifier:
NCT00927498
First received: April 29, 2009
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Drug: conventional chemotherapy (AraC + Daunorubicin),
Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acute Leukemia French Association:

Primary Outcome Measures:
  • Event Free Survival (EFS) [ Time Frame: Relapse or death measured from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CR rate [ Time Frame: CR after induction ] [ Designated as safety issue: Yes ]
  • Cumulative incidence of relapse [ Time Frame: Relapse from CR ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Survival from randomization ] [ Designated as safety issue: No ]
  • Safety of the combination Mylotarg+chemotherapy [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: December 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927498

Locations
France
CH
Argenteuil, France, 95107
Hopital Avicenne
Bobigny, France, 93309
CH
Caen, France, 14033
Hopital Percy
Clamart, France, 92141
CHU
Creteil, France, 94010
CHU
Dijon, France, 21034
CH
Lens, France, 62307
CHU
Lille, France, 59037
CH
Limoges, France, 87042
Hopital Edouard Herriot
Lyon, France, 69437
CH
Meaux, France, 77104
Hopital Saint-Louis
Paris, France
Hopital Pitie-Salpetriere
Paris, France, 75651
CH
Roubaix, France, 59100
CHU
Rouen, France, 76038
CNLCC
Saint-Cloud, France, 92210
CH
Valenciennes, France, 59322
Hospital Central
Versailles, France, 78157
IGR
Villejuif, France, 94805
Sponsors and Collaborators
Acute Leukemia French Association
Central Hospital, Versailles
Investigators
Principal Investigator: Castaigne Sylvie, Professor Central Hospital, Versailles
  More Information

No publications provided

Responsible Party: Professor Castaigne Sylvie, Central Hospital, Versailles
ClinicalTrials.gov Identifier: NCT00927498     History of Changes
Other Study ID Numbers: ALFA 0701
Study First Received: April 29, 2009
Last Updated: January 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Acute Leukemia French Association:
Acute myeloid Leukemia
patient aged 50 to 70 years

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Gemtuzumab
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on June 17, 2013