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NCT Number: NCT02473146

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

C.H.U d'Amiens - Hôpital Sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemtuzumab ozogamicin (GO)

Drug

Other names: Mylotarg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study 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

Acronym: ALFA1401

Important dates

Study start
2015
Primary completion
2021
Study completion
2023
First posted
Jun 16, 2015
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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