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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

Sponsor
Acute Leukemia French Association (Other)
Overall Status
Completed
CT.gov ID
NCT00927498
Collaborator
Versailles Hospital (Other)
280
Enrollment
19
Locations
2
Arms
67
Duration (Months)
14.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Dec 1, 2007
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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

Primary Outcome Measures

  1. Event Free Survival (EFS) [Relapse or death measured from randomization]

Secondary Outcome Measures

  1. CR rate [CR after induction]

  2. Cumulative incidence of relapse [Relapse from CR]

  3. Overall Survival [Survival from randomization]

  4. Safety of the combination Mylotarg+chemotherapy [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) [Duration of study]

  6. Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CH Argenteuil France 95107
2 Hopital Avicenne Bobigny France 93309
3 CH Caen France 14033
4 Hopital Percy Clamart France 92141
5 CHU Creteil France 94010
6 CHU Dijon France 21034
7 CH Lens France 62307
8 CHU Lille France 59037
9 CH Limoges France 87042
10 Hopital Edouard Herriot Lyon France 69437
11 CH Meaux France 77104
12 Hopital Pitie-Salpetriere Paris France 75651
13 Hopital Saint-Louis Paris France
14 CH Roubaix France 59100
15 CHU Rouen France 76038
16 CNLCC Saint-Cloud France 92210
17 CH Valenciennes France 59322
18 Hospital Central Versailles France 78157
19 IGR Villejuif France 94805

Sponsors and Collaborators

  • Acute Leukemia French Association
  • Versailles Hospital

Investigators

  • Principal Investigator: Castaigne Sylvie, Professor, Versailles Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Acute Leukemia French Association
ClinicalTrials.gov Identifier:
NCT00927498
Other Study ID Numbers:
  • ALFA 0701
First Posted:
Jun 25, 2009
Last Update Posted:
Jul 11, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Acute Leukemia French Association
Acute myeloid Leukemia
patient aged 50 to 70 years
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Daunorubicin
Gemtuzumab

Study Results

No Results Posted as of Jul 11, 2013