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

2014-08-27 03:50:54 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


CD20-Positive Large B-Cell Lymphoma


ACVBP, ACE, rituximab, Autologous stem cell transplant


Hôpital Henri Mondor




Groupe d'Etudes de Lymphomes de L'Adulte

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:50:54-0400

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Medical and Biotech [MESH] Definitions

A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.

Methods of implanting a CELL NUCLEUS from a donor cell into an enucleated acceptor cell. Often the nucleus of a somatic cell is transferred into a recipient OVUM or stem cell (STEM CELLS) with the nucleus removed. This technology may provide means to generate autologous diploid pluripotent cell for therapeutic cloning, and a model for studying NUCLEAR REPROGRAMMING in embryonic stem cells. Nuclear transfer was first accomplished with frog eggs (RANA PIPIENS) and reported in 1952.

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Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).

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