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| Name | Class |
|---|---|
| Versailles Hospital | OTHER |
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.
Patients with a morphologically proven diagnosis AML and both the two following criteria:
Randomization will be centralized by phone :
Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A Daunorubicin and Cytarabine | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional chemotherapy (AraC + Daunorubicin), | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | Relapse or death measured from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| CR rate | CR after induction | |
| Cumulative incidence of relapse | Relapse from CR | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Castaigne Sylvie, Professor | Versailles Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH | Argenteuil | 95107 | France | |||
| Hopital Avicenne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33858190 | Derived | 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. | |
| 24659740 | Derived |
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|
| Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), | Drug | 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. |
|
| Survival from randomization |
| Safety of the combination Mylotarg+chemotherapy | Duration of study |
| 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 |
| Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. | Duration of study |
| Bobigny |
| 93309 |
| France |
| CH | Caen | 14033 | France |
| Hopital Percy | Clamart | 92141 | France |
| CHU | Créteil | 94010 | France |
| CHU | Dijon | 21034 | France |
| CH | Lens | 62307 | France |
| CHU | Lille | 59037 | France |
| CH | Limoges | 87042 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| CH | Meaux | 77104 | France |
| Hopital Pitie-Salpetriere | Paris | 75651 | France |
| Hopital Saint-Louis | Paris | France |
| CH | Roubaix | 59100 | France |
| CHU | Rouen | 76038 | France |
| CNLCC | Saint-Cloud | 92210 | France |
| CH | Valenciennes | 59322 | France |
| Hospital Central | Versailles | 78157 | France |
| IGR | Villejuif | 94805 | France |
| 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. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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