Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with
 autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and
 the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated
 High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .

 The duration of the treatment period is approximately 25 weeks and patients are followed
 until Death.

 From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE
 and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who
 received HDC, 269 were randomized (R2) after hematological recovery to receive either
 rituximab (n=139) or nothing (n=130).

 The final analysis was performed in June 2005.
Inclusion Criteria:

 -  Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO
 Classification).

 -  Aged from 18 to 59 years, eligible for transplant.

 -  Patient not previously treated.

 -  Age adjusted International Prognostic Index equal to 2 or 3.

 -  Having previously signed a written informed consent.

 -  Women of childbearing potential currently practicing an adequate method of
 contraception.

 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.

 -  Poor renal function (creatinin level>150mmol/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.

 -  Any serious active disease (according to the investigator's decision).

 -  HIV, HTLV1 or HBV related disease.

 -  Any organ transplantation before inclusion.

 -  Pregnant women.