ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma

Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma

The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.

Inclusion Criteria:

• Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
• Aged 18 to 60 years
• Non previously treated
• With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level
• Negative HIV, HBV and HCV serologies (except vaccination)
• With a minimum life expectancy of 3 months
• Having previously signed a written informed consent

Exclusion Criteria:

• Any history of treated or non-treated indolent lymphoma.
• T-cell lymphoma.
• Central nervous system or meningeal involvement by lymphoma.
• Any Contra-indication to any drug contained in the chemotherapy regimens.
• 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.
• Serious active disease (according to the investigator's decision).
• Poor bone marrow reserve as defined by neutrophils <1.5G/l or platelets<100G/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.
• Childbearing woman.
• Patients previously treated with an organ transplantation.