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

September 1, 2015 updated by: Lymphoma Study Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Hôpital Henri Mondor
      • Dijon, France
        • Service d'Hématologie Clinique - CHU Le Bocage
      • Lille, France
        • Service des Maladies du Sang - CHRU de Lille
      • Lyon, France
        • Centre Léon Bérard
      • Paris, France
        • Hôpital Saint Louis
      • Paris, France
        • Service D'Hématologie Adulte - Hôpital Necker
      • Rouen, France
        • Centre Henri Becquerel
      • Vandoeuvre les Nancy, France
        • CHRU de Nancy Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-GEMOX
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
Time Frame: 16 weeks
completion of the treatment
16 weeks
Event free survival (EFS)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

Eli Lilly and Company
Hoffmann-La Roche
Sanofi-Synthelabo

Investigators

  • Study Chair: Corinne Haioun, MD, Hôpital Henri Mondor, Créteil, France
  • Principal Investigator: Corinne Haioun, MD, Hôpital Henri Mondor, Créteil, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-GEMOX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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