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

Lymphoma Study Association (LYSA)

Status and phase

Completed

Phase 2

Conditions

Diffuse Large Cell Lymphoma

Treatments

Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00169195

R-GEMOX

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.