Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Phase II Study of Mini-CHOP Plus Rituximab in Non Previously Treated Patients Aged Over 80 Years With CD 20+ Diffuse Large B-Cell Lymphoma

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.

Inclusion Criteria:

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.
• Aged over 80 years.
• Ann Arbor stage I bulky, II, III or IV
• Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3.
• Patient non previously treated.
• ECOG performance status ≤ 2.
• With a minimum life expectancy of 3 months.
• Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
• Having previously signed a written informed consent

Exclusion Criteria:

• Any other histological type of lymphoma.
• Any history of treated or non-treated indolent lymphoma.
• Central nervous system or meningeal involvement by lymphoma.
• Contra-indication to any drug contained in the chemotherapy regimens.
• Any serious active disease (according to the investigator's decision).
• Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
• Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
• Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
• Adult patient under tutelage.