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

Phase 2

Completed

• Conditions: Diffuse Large Cell Lymphoma
• Interventions: Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

• Registration Number: NCT00169195
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-GEMOX	Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)	Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])	8 weeks	4 cycles of R-GEMOX

Secondary Outcome Measures

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

Trial Locations

Locations (8)

CHRU de Nancy Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Service des Maladies du Sang - CHRU de Lille; 🇫🇷 Lille, France

Service D'Hématologie Adulte - Hôpital Necker; 🇫🇷 Paris, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Service d'Hématologie Clinique - CHU Le Bocage; 🇫🇷 Dijon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Henri Becquerel; 🇫🇷 Rouen, France