Idarubicin plus Cytosine-Arabinoside (ALL R-87 Protocol) in Advanced Acute Lymphoblastic Leukemia: The GIMEMA/AIEOP Experience

In our previous experience’, the combination of HDARA-C at a dosage of 3 g/m2/12 hours x 6 doses plus Idarubicin (IDA) (12mg/m2/day x 3 doses), follosed by bone marrow transplant (BMT) as intensive post-remission phase was employed in patients with advanced acute lymphoblastic leukemia (ALL). CR was achieved in 59% of these patients, however only 40% of them were elegible for BMT. With the aim to improve these results, we devised a new study, including induction with a different ARA-C plus IDA schedule, and a multidrug consolidation therapy, followed by BMT. The induction therapy consisted of ARA-C 1 g/m2 given as a continuous infusion for 6 hours daily for 6 days, plus IDA 5mg/m2/day as a 30-minute infusion administered 3 hours after ARA-C for a total of 6 doses (Figure 1). Responding patients received post-remission therapy, including vindesine (5 mg/m2/weekly x 2) followed by 2 courses of the L-VAMP regimen2. Intrathecal methotrexate (MTX) was given for 3 weekly doses during the postremission phase. Patients still in CR who were