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| Sponsor: | Groupe d'Etudes de Lymphomes de L'Adulte |
|---|---|
| Collaborator: |
Association pour la Recherche sur le Cancer (ARC), Villejuif, France. |
| Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
| ClinicalTrials.gov Identifier: | NCT00169130 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | LNH98-B2 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00169130 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
lymphoma autologous stem cell transplant chemotherapy BCL2 |
|
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Doxorubicin Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |