NCT01723657 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML) (NCT01723657)

Trial Description
The AML-03 regimen investigates the addition of G-CSF priming to both induction and consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines risk-stratification based on biological characterization also the AML-03 trial incorporates novel approaches for hematopoietic stem cell transplantation: such as the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) “in vivo purging” in autografts, extends unrelated volunteers donors for allotransplants in high-risk patients, and introduces reduced intensity conditioning in patients with elder age (more than 50 years old).

The aims of these modifications are to analyse efficacy and toxicity of this induction and consolidation therapy and to analyse the disease free survival in patients who achieved complete response following a risk adjusted therapy.

This trial is sponsored by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias (CETLAM) [1]

Study Data

  • Condition: Acute Myelocytic Leukemia
  • Interventions:
    • Drugs used in this trial
    • Other: Autologous peripheral blood stem cell transplantation.
    • Other: Allogeneic matched related or unrelated donor transplant.
    • Other: Mylotarg purging before autologous PBSC transplantation
    • Other: CD34+ selection.
  • Phase: II
  • Enrollment: 862
  • Start: October 2003
  • Completion: March 2012
  • Last verified: October 2012

Study Schematic

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Last Editorial review: July 24, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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