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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi-Synthelabo
Eli Lilly and Company
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00169195
First received: September 12, 2005
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Diffuse Large Cell Lymphoma
Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: end of 4 cycles of R-GEMOX ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: completion of the treatment ] [ Designated as safety issue: No ]
  • Event free survival (EFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2003
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169195

Locations
France
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
Service D'Hématologie Adulte - Hôpital Necker
Paris, France
Hôpital Saint Louis
Paris, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandoeuvre les Nancy, France
Sponsors and Collaborators
Lymphoma Study Association
Hoffmann-La Roche
Sanofi-Synthelabo
Eli Lilly and Company
Investigators
Study Chair: Corinne Haioun, MD Hôpital Henri Mondor, Créteil, France
Principal Investigator: Corinne Haioun, MD Hôpital henri Mondor, Créteil, France
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Corinne Haioun, GELA
ClinicalTrials.gov Identifier: NCT00169195     History of Changes
Other Study ID Numbers: R-GEMOX
Study First Received: September 12, 2005
Last Updated: August 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 28, 2014