Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).

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.