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Sponsors and Collaborators: |
Groupe d'Etudes de Lymphomes de L'Adulte Association pour la Recherche sur le Cancer (ARC), Villejuif, France. |
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Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
ClinicalTrials.gov Identifier: | NCT00169130 |
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.
Condition | Intervention | Phase |
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Lymphoma, Large-Cell, Diffuse |
Drug: doxorubicin Drug: cyclophosphamide Procedure: Autologous stem cell transplantation |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Service d'Hematologie | |
Mont-Godinne, Belgium | |
France | |
Hôpital Saint Louis | |
Paris, France, 75010 | |
Centre Hospitalier Lyon Sud | |
Pierre-Bénite, France | |
Centre Henri Becquerel | |
Rouen, France, 76000 | |
Hôpital Henri Mondor | |
Creteil, France |
Principal Investigator: | Pierre Morel, MD | Centre Hospitalier Schaffner, Lens FRANCE |
Study ID Numbers: | LNH98-B2 |
Study First Received: | September 12, 2005 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00169130 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
lymphoma autologous stem cell transplant chemotherapy BCL2 |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders B-cell lymphomas |
Cyclophosphamide Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Doxorubicin |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |