Clinical trial NCT00927498: A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid Leukemia
patient aged 50 to 70 years
Lead sponsor: Acute Leukemia French Association
Sponsor class: OTHER
Collaborators: name: Versailles Hospital
First posted: 2009-06-25
Enrollment: 280
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: Relapse or death measured from randomization
Secondary outcomes:
measure: CR rate
timeFrame: CR after induction
measure: Cumulative incidence of relapse
timeFrame: Relapse from CR
measure: Overall Survival
timeFrame: Survival from randomization
measure: Safety of the combination Mylotarg+chemotherapy
timeFrame: Duration of study
measure: Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)
timeFrame: Duration of study
measure: Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.
timeFrame: Duration of study
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH
city: Bobigny
country: France
facility: Hopital Avicenne
city: Caen
country: France
facility: CH
city: Clamart
country: France
facility: Hopital Percy
city: Creteil
country: France
facility: CHU
city: Dijon
country: France
facility: CHU
city: Lens
country: France
facility: CH
city: Lille
country: France
facility: CHU
city: Limoges
country: France
facility: CH
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Meaux
country: France
facility: CH
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Saint-Louis
city: Roubaix
country: France
facility: CH
city: Rouen
country: France
facility: CHU
city: Saint-Cloud
country: France
facility: CNLCC
city: Valenciennes
country: France
facility: CH
city: Versailles
country: France
facility: Hospital Central
city: Villejuif
country: France
facility: IGR
Study officials:
affiliation: Versailles Hospital
name: Castaigne Sylvie, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.