A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
NCT ID: NCT00927498
Last Updated: 2013-07-11
Study Results
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Basic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2007-12-31
2013-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* AML following previously know myeloproliferative syndrome.
* Known central nervous system involvement.
* Uncontrolled infection
* Other active malignancy
50 Years
70 Years
ALL
No
Sponsors
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Versailles Hospital
OTHER
Acute Leukemia French Association
OTHER
Responsible Party
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Principal Investigators
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Castaigne Sylvie, Professor
Role: PRINCIPAL_INVESTIGATOR
Versailles Hospital
Locations
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CH
Argenteuil, , France
Hopital Avicenne
Bobigny, , France
CH
Caen, , France
Hopital Percy
Clamart, , France
CHU
Créteil, , 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, , France
Countries
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References
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Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.
Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Dulery R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32. doi: 10.18632/oncotarget.1536.
Other Identifiers
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ALFA 0701
Identifier Type: -
Identifier Source: org_study_id
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