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Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4 (ALFA1401)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02473146
Recruitment Status : Unknown
Verified July 2018 by Ms Juliette LAMBERT, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : June 16, 2015
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ms Juliette LAMBERT, Versailles Hospital

Study Description
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Brief Summary:

Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.

Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Gemtuzumab ozogamicin (GO) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable
Actual Study Start Date : November 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mylotarg Arm

After randomization patients in the experimental arm are assigned to receive chemotherapy with:

Gemtuzumab Ozogamicin 3 mg/m2 (maximum dose: 5 mg) per IV, 60mn on Day 1 and 4 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7

 Drug: Gemtuzumab ozogamicin (GO)
Other Name: Mylotarg
No Intervention: Control Arm
After randomization patients in the control arm are assigned to receive chemotherapy with Idarubicin 12mg/m2 per IV, 30mn on Day 1,2,3 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7


Outcome Measures
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Primary Outcome Measures :
  1. EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death) [ Time Frame: 5 years ]
    Endoint for the primary objective of efficacy is EFS defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death.


Secondary Outcome Measures :
  1. Composite measure for Efficacy assessed by CR/Cri rates, cumulative incidence of relapse, overall survival. [ Time Frame: 5 years ]
  2. Composite measure for safety [ Time Frame: 5 years ]
    • incidence of early deaths < day 30 and day 60,
    • grade 3 to 5 adverse events and all serious adverse events during induction and consolidation treatment
    • cardiac toxicity evaluated on cardiac ejection function evaluation by echocardiography or isotopic measure.
    • Quality of life measured by questionaries' EORTC QLQ-C30 repeated at diagnosis, after induction treatment, after the two consolidations and 3 months after the end of treatment.

    End points for treatment-by-covariate interactions are

    • at diagnosis: percentage of CD33 positivity on blast cells, measured with a standardized method, cytogenetics and most relevant molecular markers (FLT3, MLL, CEBPa, NPM1, DNMT3a.,
    • after induction and end of treatment: minimal residual disease determined by WT1 and/or NPM1 transcripts levels.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a morphologically proven diagnosis AML and both the following criteria:
  • Age ≥ 60 years and < 80 years.
  • Not previously treated for their disease.
  • With favourable or intermediate-risk cytogenetics. (Patients with urgent clinical need to begin treatment might be included before cytogenetic results, when necessary if they do not respond to Hydroxyurea. Patients might be included if the cytogenetic results are not expected in a time limit < 5 days after AML diagnosis).
  • Fit to receive intensive chemotherapy
  • Cardiac function determined by radionucleide or echography within normal limits.
  • Signed informed consent

Exclusion Criteria:

  • M3-AML
  • Presence of adverse cytogenetics (according to European LeukemiaNet recommendation.) (17) defined as one of the following abnormalities: -5/5q-, -7, t(6;9), t(v;11q23) excluding t(9;11), inv(3)(q21;q26.2) or t(3;3)(q21;q26.2), complex karyotype (3+ abnormalities)
  • Secondary AML following treatment with radiotherapy or chemotherapy.
  • AML following previously known myeloproliferative or myelodysplastic syndrome.
  • ECOG performance status (PS) 0 to 3
  • Serum creatinin level > or = 2.5N; AST and ALT level > or = 2.5N; total bilirubin level > or = 2N
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473146


Contacts
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Contact: Assitan KONE 0139239775 akone@ch-versailles.fr
Contact: Laure MORISSET 0139239785 lmorisset@ch-versailles.fr

Locations
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Sponsors and Collaborators
Versailles Hospital
Investigators
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Principal Investigator: Juliette LAMBERT, MD Versailles Hospital
Principal Investigator: Sylvie CASTAIGNE, MD Versailles Hospital
More Information
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Responsible Party: Ms Juliette LAMBERT, Clinical coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02473146    
Other Study ID Numbers: 2014-001395-65
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Keywords provided by Ms Juliette LAMBERT, Versailles Hospital:
AML
untreated
60-80 years old
favorable and intermediate karyotype
Additional relevant MeSH terms:
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Gemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunotoxins
 Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs