Burkitt Lymphoma Clinical Trial
Official title:
Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma
The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy
combination programme originally introduced by GMALL (the German cooperative group for adult
acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free
survival rates of adult patients with Burkitt's leukemia and lymphoma.
The therapy includes a maximum of six chemotherapy courses (two with high doses of
methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses),
supplemented by local radiation therapy in the case of initial mediastinal or central
nervous system (CNS) involvement or a residual tumor after chemotherapy.
Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy
on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple
intrathecal therapy).
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.
Notes:
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).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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