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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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
conventional chemotherapy (AraC + Daunorubicin),
Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
Sponsored by
Acute Leukemia French Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid Leukemia, patient aged 50 to 70 years

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH
  • Hopital Avicenne
  • CH
  • Hopital Percy
  • CHU
  • CHU
  • CH
  • CHU
  • CH
  • Hopital Edouard Herriot
  • CH
  • Hopital Pitie-Salpetriere
  • Hopital Saint-Louis
  • CH
  • CHU
  • CNLCC
  • CH
  • Hospital Central
  • IGR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A Daunorubicin and Cytarabine

Arm B Daunorubicin and Cytarabine and Mylotarg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

Secondary Outcome Measures

CR rate
Cumulative incidence of relapse
Overall Survival
Safety of the combination Mylotarg+chemotherapy
Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)
Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.

Full Information

First Posted
April 29, 2009
Last Updated
July 10, 2013
Sponsor
Acute Leukemia French Association
Collaborators
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00927498
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acute Leukemia French Association
Collaborators
Versailles Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid Leukemia, patient aged 50 to 70 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Daunorubicin and Cytarabine
Arm Type
Active Comparator
Arm Description
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 Title
Arm B Daunorubicin and Cytarabine and Mylotarg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
conventional chemotherapy (AraC + Daunorubicin),
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event Free Survival (EFS)
Time Frame
Relapse or death measured from randomization
Secondary Outcome Measure Information:
Title
CR rate
Time Frame
CR after induction
Title
Cumulative incidence of relapse
Time Frame
Relapse from CR
Title
Overall Survival
Time Frame
Survival from randomization
Title
Safety of the combination Mylotarg+chemotherapy
Time Frame
Duration of study
Title
Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)
Time Frame
Duration of study
Title
Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.
Time Frame
Duration of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Castaigne Sylvie, Professor
Organizational Affiliation
Versailles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93309
Country
France
Facility Name
CH
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHU
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
CH
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHU
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CH
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CH
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
Country
France
Facility Name
CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CNLCC
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
CH
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Hospital Central
City
Versailles
ZIP/Postal Code
78157
Country
France
Facility Name
IGR
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33858190
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.
Results Reference
derived
PubMed Identifier
24659740
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.
Results Reference
derived

Learn more about this trial

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

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