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Trial record 44 of 877 for:    "Reticulum Cell Sarcoma"

Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169195
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 2, 2015
Hoffmann-La Roche
Eli Lilly and Company
Information provided by (Responsible Party):
Lymphoma Study Association

Brief Summary:
The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.

Condition or disease Intervention/treatment Phase
Diffuse Large Cell Lymphoma Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX) Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: R-GEMOX
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

Primary Outcome Measures :
  1. Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 8 weeks ]
    4 cycles of R-GEMOX

Secondary Outcome Measures :
  1. Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 16 weeks ]
    completion of the treatment

  2. Event free survival (EFS) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with histologically or cytologically proven, CD 20+, diffuse large B-cell lymphoma,
  • Relapse after first or second CR, PR or less than PR to first-line treatment for the rituximab-naïve patients, OR relapse after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for the rituximab-experienced patients
  • Aged 18 - 75 years
  • Not eligible for autologous transplantation
  • Previously treated with chemotherapy containing anthracycline, with or without rituximab
  • ECOG performance status 0 to 2
  • With a minimum life expectancy of 3 months
  • Having signed informed consent form prior to enrollment

Exclusion Criteria:

  • Burkitt's, mantle cell, T-cell lymphomas
  • CD 20-negative lymphoma
  • HIV or HBV related disease
  • Central nervous system or meningeal involvement by the lymphoma
  • Not previously treated with anthracycline-containing regimens
  • Contraindication to any drug contained in the R-GEMOX chemotherapy regimen
  • Any serious active disease or co-morbid medical condition (according to the investigator's decision),
  • Poor renal function (creatinine level > 150micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
  • Any radiotherapy during the four weeks before inclusion
  • Pregnant or lactating woman
  • Adult patient unable to give informed consent because of intellectual impairment.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00169195

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Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
Service des Maladies du Sang - CHRU de Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital Saint Louis
Paris, France
Service D'Hématologie Adulte - Hôpital Necker
Paris, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandoeuvre les Nancy, France
Sponsors and Collaborators
Lymphoma Study Association
Hoffmann-La Roche
Eli Lilly and Company
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Study Chair: Corinne Haioun, MD Hôpital Henri Mondor, Créteil, France
Principal Investigator: Corinne Haioun, MD Hôpital henri Mondor, Créteil, France

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lymphoma Study Association Identifier: NCT00169195     History of Changes
Other Study ID Numbers: R-GEMOX
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Lymphoma Study Association:
B-cell lymphoma
Salvage Therapy

Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antirheumatic Agents