NCT00860639 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Efficacy of Gemtuzumab Ozogamycin for Patients Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk (LAM2006IR) (NCT00860639)

Trial Description
The main objective of the study is to improve outcome of younger patients (between 18-60 years) with acute myeloid leukemia and intermediate risk defined by the cytogenetics. In this population, in the absence of bone marrow transplantation, event free survival (EFS) is estimated at 35% after three years of follow-up. Adjunction of the antibody-drug conjugate gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) to standard chemotherapy is supposed to increase EFS up to 50% at 3 years.

To test this hypothesis, the Groupe Ouest Est d’Etude des Leucémies et Autres Maladies du Sang (GOELAMS ) sponsored by Nantes University Hospital leads this randomized open phase III trial in 29 French centers.

This trial is sponsored by Nantes University Hospital. [1]

Study Data

  • Condition: Acute Myeloid Leukemia
  • Interventions:
  • Phase: III
  • Enrollment: 327
  • Start: October 2007
  • Estimated Completion: October 2016
  • Last verified: March 2015

Study Schematic

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Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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