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A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg) Induction Therapy Versus Standard Induction With Daunomycin [daunorubicin] and Cytosine Arabinoside [cytarabine] Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg) or No Additional Therapy For Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML).

Trial Profile

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg) Induction Therapy Versus Standard Induction With Daunomycin [daunorubicin] and Cytosine Arabinoside [cytarabine] Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg) or No Additional Therapy For Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML).

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2018

At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms GAIN
  • Most Recent Events

    • 04 Dec 2018 Results evaluating event-free survival (EFS) as a surrogate endpoint for OS in untreated AML from 4 multicenter, randomized controlled phase III trials (n=2475), NCT00085124, NCT00651261,NCT00085709, NCT00049517, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 31 Aug 2018 Biomarkers information updated
    • 04 Mar 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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