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Sponsors and Collaborators: |
Groupe d'Etudes de Lymphomes de L'Adulte Hoffmann-La Roche |
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Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
ClinicalTrials.gov Identifier: | NCT00169156 |
To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
Condition | Intervention | Phase |
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Untreated T-Cell Angioimmunoblastic Lymphoma |
Drug: Rituximab + CHOP regimen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-Cell Angioimmunoblastic Lymphoma (AIL). |
Estimated Enrollment: | 25 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2009 |
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
The total Duration of the study is expected to be 2.5 years.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hôpital Henri Mondor | |
Créteil, France | |
Hôpital Saint Louis | |
Paris, France | |
Centre Henri Becquerel | |
Rouen, France | |
Service d'Hématologie - Centre Hospitalier Lyon-Sud | |
Pierre-Bénite cedex, France, 69495 |
Study Chair: | Corinne Haioun, MD | Hôpital Henri Mondor, Créteil, France |
Principal Investigator: | Bertrand Joly, MD | C.H. Sud Francilien, Corbeil-Essonnes, France |
Study ID Numbers: | RAIL, EUDRACT Number: 2005-002602-37 |
Study First Received: | September 12, 2005 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00169156 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
T-cell angioimmunoblastic lymphoma Rituximab |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Immunoblastic Lymphadenopathy |
Lymphoma, Large-Cell, Immunoblastic Lymphoproliferative Disorders Lymphoma Lymphoma, large-cell, immunoblastic |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |