Overview

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

Status:
Completed
Trial end date:
2016-09-26
Target enrollment:
Participant gender:
Summary
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 gemtuzumab ozogamycin (MYLOTARG®) 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.
Phase:
Phase 3
Details
Lead Sponsor:
Nantes University Hospital
Collaborators:
Chugai Pharmaceutical
French Innovative Leukemia Organisation
Treatments:
Gemtuzumab