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Sponsored by: |
Groupe d'Etudes de Lymphomes de L'Adulte |
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Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
ClinicalTrials.gov Identifier: | NCT00140569 |
2 parallel studies.
Condition | Intervention | Phase |
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Follicular Lymphoma |
Procedure: CHVP + interferon Drug: fludarabine Procedure: CHOP + TBI and autotransplant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Study for Patients With Follicular Lymphoma Needing Treatment |
Estimated Enrollment: | 400 |
Study Start Date: | January 1994 |
Estimated Study Completion Date: | January 2004 |
2 parallel studies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Groupe d'atude des lymphome de l'adulte | |
Yvoir, Belgium | |
France | |
Centre Henri Becquerel | |
Rouen, France, 76038 | |
Centre Hospitalier Robert Debré | |
Reims, France, 51092 | |
Hôpital Henri Mondor | |
Créteil, France, 94010 | |
Centre Léon Bérard | |
Lyon, France, 69008 | |
Institut Gustave Roussy | |
Villejuif, France | |
Service d'Hématologie - Centre Hospitalier Lyon-Sud | |
Pierre-Bénite cedex, France, 69495 | |
Hôpital Saint Louis | |
Paris, France, 75010 |
Study Chair: | Bertrand Coiffier, MD | Hospices Civils de Lyon |
Principal Investigator: | Catherine Sebban, MD | Centre Léon Bérard |
Study ID Numbers: | Gelf-94 |
Study First Received: | August 31, 2005 |
Last Updated: | August 31, 2005 |
ClinicalTrials.gov Identifier: | NCT00140569 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
follicular lymphoma CHVP + interferon fludarabine autotransplant |
Lymphatic Diseases Immunoproliferative Disorders Interferons Lymphoma, Follicular Fludarabine |
Fludarabine monophosphate Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors |
Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |