Randomized induction and post induction therapy in older patients (>= 61 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).

Study phase:

phase III.




Study objectives:

evaluation of the effect of an escalated dose of Daunomycin in induction treatment. Evaluation of the effect of maintenance treatment with GO for patients in CR.




Patient population:

patients with AML except FAB M3 or t(15;17), RAEB or RAEB-t with IPSS >= 1.5, previously untreated, age >= 61 yrs.




Study design:

prospective, multicenter, randomized with randomization up front for induction treatment and randomization of patients in CR for maintenance treatment or not.




Duration of treatment:

expected duration of 2 cycles of induction treatment inclusive evaluation is about 3 months. For patients in CR, randomized to GO, the additional treatment time is between 12 and 36 weeks.

The first hypothesis to be tested is that the outcome in arm B is better than in arm A.
The second hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.

N/A

Patients will be randomized on entry for induction between:




Arm A:

Cycle I: conventional type daunomycin-cytarabine schedule;
Cycle II: intermediate dose cytarabine

Arm B:

Cycle I: daunomycin at escalated dose with standard dose cytarabine;

Cycle II: intermediate dose cytarabine.




Patients attaining CR and remaining in CR after cycle II will be randomized between:




Arm 1: no further treatment.

Arm 2: 3 dosages of gemtuzumab ozogamicin (GO, Mylotarg) at 4 week intervals.




For patients with an HLA identical sibling donor, an allograft with non-myeloablative conditioning, will be available depending on the active involvement in allotransplantation per center (optional per center).