Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma
Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy
on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple
Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine,
cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1:
Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose
methotrexate, etoposide, high-dose cytarabine).
Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle
C1. Cycle C2 is followed by two additional Rituximab injections.
1. patients with stage I-II disease without mediastinal tumor or extranodal involvement
receive only the first 4 cycles (A1 to A2).
2. patients aged >55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or
A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients alive without disease at 5 years from date of diagnosis
Renato Bassan, MD
USC Ematologia Ospedali Riuniti di Bergamo
Italy: Ministry of Health