Effect of Priming With Granulocyte-Macrophage Colony-Stimulating Factor During Chemotherapy and Comparison of Timed Sequential Chemotherapy vs 4 Courses of High Dose Cytarabine as Consolidation in Younger Adults With Newly Diagnosed AML
Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during
all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy
consists of a timed-sequential chemotherapy including a first sequence of chemotherapy
combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days
(days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same
period. The second sequence, administered after 4-day free interval, consists of
mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and
9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10).
Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine,
100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia
Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day,
intravenously beginning at day 1 of each chemotherapy course and continuing until the last
day of chemotherapy of each course.
Patients who achieve CR after induction chemotherapy or salvage therapy are randomly
assigned to consolidation courses consisting of either a timed sequential chemotherapy
similar to that of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1
arm), which includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessing the potential value of the daily administration of GM-CSF during induction chemotherapy and post-induction for analyzing and comparing the arms with and without GM-CSF: EFS, % of CR, duration of remission, OS and toxicity of each treatment.
XAVIER THOMAS, MD, PhD
Hospices Civils de Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)