Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00169195|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large Cell Lymphoma||Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
|Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)|
- Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 8 weeks ]4 cycles of R-GEMOX
- Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 16 weeks ]completion of the treatment
- Event free survival (EFS) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169195
|Hôpital Henri Mondor|
|Service d'Hématologie Clinique - CHU Le Bocage|
|Service des Maladies du Sang - CHRU de Lille|
|Centre Léon Bérard|
|Hôpital Saint Louis|
|Service D'Hématologie Adulte - Hôpital Necker|
|Centre Henri Becquerel|
|CHRU de Nancy Brabois|
|Vandoeuvre les Nancy, France|
|Study Chair:||Corinne Haioun, MD||Hôpital Henri Mondor, Créteil, France|
|Principal Investigator:||Corinne Haioun, MD||Hôpital henri Mondor, Créteil, France|