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

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ClinicalTrials.gov Identifier: NCT02473146
Recruitment Status : Recruiting
First Posted : June 16, 2015
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ms Juliette LAMBERT, Versailles Hospital

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

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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


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



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.



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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

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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France
C.H.U d'Amiens - Hôpital Sud Recruiting
Amiens, France
Contact: Bérangère GRUSON         
Principal Investigator: Bérangère GRUSON         
Hôpital V. Dupouy Recruiting
Argenteuil, France
Contact: Ahmad AL JIJAKI         
Principal Investigator: Ahmad AL JIJAKI, MD         
CH Avicenne Recruiting
Bobigny, France
Contact: Claude GARDIN         
Principal Investigator: Claude GARDIN, MD         
CHU Caen Recruiting
Caen, France
Contact: Sylvain CHANTEPIE         
Principal Investigator: Sylvain CHANTEPIE, MD         
HIA Percy Recruiting
Clamart, France, 92140
Contact: Jean-Valère MALFUSON, MD         
Principal Investigator: Jean-Valère MALFUSON, MD         
Hopital Henri Mondor Recruiting
Creteil, France
Contact: Cecile PAUTAS         
Principal Investigator: Cecile PAUTAS, MD         
CHU Dijon Recruiting
Dijon, France
Contact: Denis CAILLOT         
Principal Investigator: Denis CAILLOT, MD         
CH Dunkerque Recruiting
Dunkerque, France
Contact: Iriné Maxime BEMBA         
Principal Investigator: Iriné Maxime BEMBA, MD         
CH Versailles Recruiting
Le Chesnay, France, 78157
Contact: Juliette LAMBERT, MD         
Principal Investigator: Juliette LAMBERT, MD         
Hôpital Huriez, CHU de Lille Recruiting
Lille, France
Contact: Bruno QUESNEL         
Principal Investigator: Bruno QUESNEL, MD         
CHU Limoges Recruiting
Limoges, France
Contact: Pascal TURLURE         
Principal Investigator: Pascal TURLURE, MD         
Hôpital de la Conception Active, not recruiting
Marseille, France, 13005
Centre Antoine Lacassagne Recruiting
Nice, France, 06100
Contact: Lauris GASTAUD, MD         
Principal Investigator: Lauris GASTAUD, MD         
CHU d'Orléans Recruiting
Orléans, France, 45100
Contact: Diana CARP, MD         
Principal Investigator: Diana CARP, MD         
Hopital Necker Recruiting
Paris, France
Contact: Olivier HERMINE         
Principal Investigator: Olivier HERMINE, MD         
Hopital St Louis Recruiting
Paris, France
Contact: Hervé Dombret, MD         
Principal Investigator: Hervé Dombret, MD         
Principal Investigator: Pierre FENAUX, MD         
Hôpital Saint Antoine Recruiting
Paris, France
Contact: Ollivier LEGRAND, MD         
Principal Investigator: Ollivier LEGRAND, MD         
CHU Lyon Sud Recruiting
Pierre Benite, France
Contact: Xavier THOMAS         
Principal Investigator: Xavier THOMAS         
Centre H Becquerel Recruiting
Rouen, France
Contact: Emilie LEMASLE         
Principal Investigator: Emilie LEMASLE, MD         
Institut de Cancérologie de la Loire Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Emmanuelle TAVERNIER-TARDY, MD         
Principal Investigator: Emmanuelle TAVERNIER-TARDY, MD         
IGR Not yet recruiting
Villejuif, France
Contact: Stephane DE BOTTON         
Principal Investigator: Stephane DE BOTTON, MD         
Sponsors and Collaborators
Versailles Hospital
Investigators
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Principal Investigator: Juliette LAMBERT, MD Versailles Hospital
Principal Investigator: Sylvie CASTAIGNE, MD Versailles Hospital

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Responsible Party: Ms Juliette LAMBERT, Clinical coordinator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT02473146     History of Changes
Other Study ID Numbers: 2014-001395-65
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: July 25, 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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Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Idarubicin
Gemtuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological