Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
Study Evaluating Relapses in Central Nervous System in Patients With Diffuse Large B-Cell Lymphoma Treated With Chemotherapy With or Without CNS Prophylaxis. Multicentric, Prospective, Randomized Phase III Study
Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).
Patients with diffuse large B-cell lymphoma are evaluated for risk factors of CNS relapse
during initial staging (age > 60years, lactate dehydrogenase (LDH) > reference range,
clinical stage III/IV, performance status according to Eastern Cooperative Oncology Group
(ECOG) >1, kidney and/or adrenal gland involvement, involvement > 1 extranodal organ)
including evaluation of cerebrospinal fluid.
All patients with systemic DLBCL without CNS involvement are treated with systemic
chemotherapy: either 6 cycles of R CHOP (rituximab, cyclophosphamide, doxorubicin,
vincristine, prednison) +2xR (rituximab) or 6 cycles of DA EPOCH R (dose adjusted etoposide,
prednison, vincristin, cyclophosphamide, doxorubicin) +2xR (rituximab). Patients with ≥ 2
risk factors for CNS relapse or with occult meningeal involvement will be randomized in 1:1
ratio either into arm A with 2 cycles of prophylactic methotrexate 3g/m2 i.v., or into arm B
with prophylactic 6x intrathecal methotrexate 12mg (1x intrathecal methotrexate in each
cycle of systemic chemotherapy). Patients with 0-1 risk factor will be allocated into arm C
without CNS prophylaxis. Patients will be observed for CNS relapse during the follow-up of
1year after the end of the first-line treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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