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Sponsors and Collaborators: |
Groupe d'Etudes de Lymphomes de L'Adulte Hoffmann-La Roche Sanofi-Synthelabo Eli Lilly and Company |
Information provided by: | Groupe d'Etudes de Lymphomes de L'Adulte |
ClinicalTrials.gov Identifier: | NCT00169195 |
To evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma non eligible for autologous transplantation.
Condition | Intervention | Phase |
Diffuse Large Cell Lymphoma |
Drug: Gemcitabine-Oxaliplatine plus Rituximab (R-GEMOX) |
Phase II |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Rituximab Oxaliplatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Gemcitabine-Oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-Cell Lymphoma, Non Eligible for High-Dose Chemotherapy Followed by Autotransplantation |
Estimated Enrollment: | 50 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | January 2008 |
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of R-GEMOX in refractory/relapsed patients aged from 18 to 75 years with CD20-positive large B-cell lymphoma non eligible for autologous transplantation.
It is anticipated that 50 subjects will be enrolled over 4 years (from April 2003 / January 2007), but inclusion could stop earlier according to the analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 16 weeks and patients are followed until Death.
The total Duration of the study is expected to be 3 years.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Corinne Haioun, MD | 33 149 81 2051 | corinne.haioun@hmn.aphp.fr |
France | |||||
Centre Henri Becquerel | Recruiting | ||||
Rouen, France | |||||
Contact: Hervé Tilly, MD 33 232082221 herve.tilly@gela.org | |||||
Principal Investigator: Hervé Tilly, MD | |||||
Hôpital Saint Louis | Recruiting | ||||
Paris, France | |||||
Contact: Christian Gisselbrecht, MD 33 142499296 christian.gisselbrecht@sls.ap-hop-paris.fr | |||||
Principal Investigator: Christian Gisselbrecht, MD | |||||
Service D'Hématologie Adulte - Hôpital Necker | Recruiting | ||||
Paris, France | |||||
Contact: Richard Delarue, MD 33 1444952 96 richard.delarue@nck.aphp.fr | |||||
Principal Investigator: Richard Delarue, MD | |||||
Service des Maladies du Sang - CHRU de Lille | Recruiting | ||||
Lille, France | |||||
Contact: Frank Morshhauser 33 320446068 f-morschhauser@chru-lille.fr | |||||
Principal Investigator: Frank Morschhauser, MD | |||||
Hôpital Henri Mondor | Recruiting | ||||
Créteil, France | |||||
Contact: Corinne Haioun, MD 33 149812051 corinne.haioun@hmn.aphp.fr | |||||
Principal Investigator: Corinne Haioun, MD | |||||
CHRU de Nancy Brabois | Recruiting | ||||
Vandoeuvre les Nancy, France | |||||
Contact: Pierre Lederlin, MD 33 383153283 p.lederlin@chu-nancy.fr | |||||
Principal Investigator: Pierre Lederlin, MD | |||||
Centre Léon Bérard | Recruiting | ||||
Lyon, France | |||||
Contact: Catherine Sebban 33 478782737 sebban@lyon.fnclcc.fr | |||||
Principal Investigator: Catherine Sebban, MD | |||||
Service d'Hématologie Clinique - CHU Le Bocage | Recruiting | ||||
Dijon, France | |||||
Contact: Olivier Casasnovas, MD 33 380295041 olivier.casasnovas@chu-dijon.fr | |||||
Principal Investigator: Olivier Casasnovas, MD |
Groupe d'Etudes de Lymphomes de L'Adulte |
Hoffmann-La Roche |
Sanofi-Synthelabo |
Eli Lilly and Company |
Study Chair: | Corinne Haioun, MD | Hôpital Henri Mondor, Créteil, France |
Principal Investigator: | Corinne Haioun, MD | Hôpital henri Mondor, Créteil, France |
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french) 
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Study ID Numbers: | R-GEMOX |
First Received: | September 12, 2005 |
Last Updated: | July 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00169195 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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