A Randomized Trial Assessing the Roles of AraC in Newly Diagnosed Acute Promyelocytic Leukemia (APL)
All patients will receive induction treatment with ATRA and a first chemotherapy course,
followed by two consolidation chemotherapy courses and maintenance with continuous low dose
chemotherapy and intermittent ATRA. Initial stratification will be based on age and WBC
Patients aged 60 years with initial WBC 10 00 will all receive the reference AraC+ group
(Group A ) (no randomization).
Patients with initial WBC > 10000/mm3 will initially all be treated according to the AraC+
Patients > 60 years and with initial WBC ≤ 10000/mm3) will be only registered, without
randomization (Group D) and will receive the reference AraC+ group ,but without AraC
during the first chemotherapy course ,and with reduced doses of AraC during the second and
third course, followed by G-CSF. .
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
for patients with initial WBC counts > 10000/mm3 - the main end point for this second randomization is relapse at 2 years
Pierre Fenaux, MD
Assistance Publique - Hôpitaux de Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)