Randomized Open Phase III Trial Testing Efficacy of Gemtuzumab Ozogamycin (MYLOTARG) Associated to Intensive Chemotherapy for Patients Aged Between 18-60 Years and Presenting an Acute Myeloid Leukemia (AML) With Intermediate Risk
Initial randomization will be completed upon receipt of karyotype results and will determine
the administration of gemtuzumab ozogamycin (MYLOTARG ®) in combination with chemotherapy
during the induction course and the first intensive consolidation course. The induction
course include: Daunorubicin for 3 days (60mg/m²) associated with cytarabine (200mg/m²) for
7 days. The MYLOTARG ® will be administered according to the randomization arm on the 4th
day of treatment by slow intravenous infusion of 2 hours at a dose of 6 mg/m2. Early bone
marrow assessment will be performed at D15. In case of blast excess (>5%) , a second course
of induction will be administered.
The consolidation treatment depends on age, molecular prognostic factors, and donor
- Patients with good molecular prognosis profile [ NPM1 + / FLT3 ITD - or CEBPa mutated ]
will be consolidated by two courses of intensive chemotherapy comprising Mitoxanthrone
and intermediate dose of Cytarabine with or without MYLOTARG ® according to the initial
randomization during the first course.
- Patients younger than 51 years, eligible for standard allogeneic transplantation with
sibling or full matched unrelated donor will receive a standard bone marrow
transplantation which not begin before 90 days after the induction.
- Patients with no donor or older than 50 years, or with a donor being identified, will
receive two courses of intensive consolidation comprising Mitoxantrone and
intermediate-dose of Cytarabine with or without Mylotarg ® 6 mg / m² during the first
consolidation according to the randomisation arm.
- Patients aged 51 to 60 years with an HLA identical donor (sibling or unrelated), will
receive a non-myeloablative haematopoietic stem cells transplant (HSCT) after the
second course of consolidation.
- For other patients, an autologous hematopoietic stem cells transplant (HSCT) will be
performed after the 2nd course of consolidation. Collection of peripheral blood stem
cells (PBSCs) will be performed after the first consolidation course and a second
collection may be considered after the second consolidation course in case of
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
event free survival (EFS)after 3 years for patients not eligible for standard allogenic transplantation
Jacques Delaunay, MD
Nantes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)