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

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: Rituximab

Criteria

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.