A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

Acute Myeloid Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927498
• Other study ID #: ALFA 0701
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2009
• Last updated: July 10, 2013
• Start date: December 2007
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Acute Leukemia French Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: July 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CH	Argenteuil
France	Hopital Avicenne	Bobigny
France	CH	Caen
France	Hopital Percy	Clamart
France	CHU	Creteil
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

Sponsors (2)

Lead Sponsor	Collaborator
Acute Leukemia French Association	Central Hospital, Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival (EFS)		Relapse or death measured from randomization	No
Secondary	CR rate		CR after induction	Yes
Secondary	Cumulative incidence of relapse		Relapse from CR	No
Secondary	Overall Survival		Survival from randomization	No
Secondary	Safety of the combination Mylotarg+chemotherapy		Duration of study	Yes
Secondary	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	No
Secondary	Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.		Duration of study	No