Randomised phase III study on the effect of early intensification of rituximab in combination with two-weekly cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy followed by rituximab maintenance in elderly patients (66 to 80 years) with diffuse large B-cell lymphoma

INTERVENTION: Arm A: eight cycles of rituximab and cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP14) plus Granulocyte Colony‐Stimulating Factor (G‐CSF) pegfilgrastim (Neulasta) Arm B: eight cycles of R‐CHOP14 plus G‐CSF pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first four cycles Arm 1: no further treatment Arm 2: maintenance treatment with rituximab (MabThera) once every eight weeks until relapse (for a maximum period of 24 months) CONDITION: Diffuse large B‐cell lymphoma ; Cancer ; Malignant neoplasms PRIMARY OUTCOME: First randomisation:; Response rate (complete remission and 18‐fluoro‐2‐deoxy‐glucose‐positron emission tomography [FDG‐PET] negative partial remission or unconfirmed complete remission) ; ; Second randomisation:; Failure free survival (measured from the date of second randomisation); ; The protocol prescribes response evaluation during treatment after 4 and 8 cycles of R‐CHOP and every 8 weeks during maintenance/observation. Thereafter follow up will be done every 6 months during the next 3 years and annually thereafter till 10 years after entry of the last patient. The total number of patients is expected to be recruited within 5 years. The analysis will be done approx 1 year after entry of the last patient. SECONDARY OUTCOME: First randomisation:; 1. Failure free survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive; 2. Overall survival measured from the time of registration; 3. Time to reach response; 4. Toxicity; ; Second randomisation:; 1. Overall survival; 2. Toxicity; ; The protocol prescribes response evaluation during treatment after 4 and 8 cycles of R‐CHOP and every 8 weeks during maintenance/observation. Thereafter follow up will be done every 6 months during the next 3 years and annually thereafter till 10 years after entry of the last patient. The total number of patients is expected to be recruited within 5 years. The analysis will be done approx 1 year after entry of the last patient. INCLUSION CRITERIA: 1. Patients with a confirmed histological diagnosis of Diffuse Large B‐Cell Lymphoma (DLBCL) based upon a representative histology specimen according to the World Health Organisation (WHO) classification 2. DLBCL must be CD20 positive 3. Ann Arbor stages II ‐ IV 4. Greater than or equal to 66 and less than or equal to 80 years 5. Age WHO performance status 0 to 2 6. Written informed consent