Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

INTERVENTION: A:R‐CHOP B:RW+CHOP(weekly rituximab plus CHOP) CONDITION: CD20 positive diffuse large B cell lmyphoma PRIMARY OUTCOME: phaseII : complete response rate; phaseIII : progression free survival SECONDARY OUTCOME: phaseII : progression free survival, overall survival, adverse events, seriouse adverse events; phaseIII : overall survival, adverse events, seriouse adverse events INCLUSION CRITERIA: (1)CD20 positive diffuse large B‐cell lymphoma (WHO classification), excluding histological transformation form marginal zone B cell lymphoma or follicular lymphoma and immunodeficiency associated lymphoproliferative disorders. (2) lymphoma with CD20 positive by immunohistochemistry or flow cytometry (3)clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry. (4)stage I disease without bulky mass inappropriate for chemo‐radiotherapy (5)lymphoma cells in peripheral blood: no more than 10000/mm3 (6)Performance Status: 0‐2 (7)no CNS invasion (8)having measurable lesion (9)no prior chemotherapy, radiotherapy and anti‐body therapy (10)WBC: more than 3000/mm3 (11)neutrophil: more than 1000/mm3 (12)platlets: more than 10x104/mm3 (13)AST: no more than 150 U/L (14)ALT: male: no more than 210 U/L female: no more than 115 U/L (15)T‐bil: no more than 2.0mg/dl (16)creatinine: no mo