Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
Untreated CD20-positive Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for Untreated CD20-positive Large B-cell Lymphoma focused on measuring Diffuse large B cell lymphoma, Pegfilgrastim, Autotransplant
Eligibility Criteria
Inclusion Criteria: Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). Age >18 and < 61 years, eligible for transplant. Patient not previously treated. With at least two prognostic factors of the Aa-IPI. With a minimum life expectancy of 3 months. Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma. Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration. Negative HIV, HBV and HCV serologies 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 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). Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. Adult patient under tutelage.
Sites / Locations
- Hôpital Henri Mondor
- Service d'Hématologie Clinique - CHU Le Bocage
- Hôpital Saint Louis
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
- Centre Henri Becquerel
- CHRU de Nancy Brabois