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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT00169195
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Lymphoma Study Association
• Public title: Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
• Scientific 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
• Date of first enrolment: April 2003
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00169195
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Corinne Haioun, MD
• Affiliation: Hôpital Henri Mondor, Créteil, France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Large Cell Lymphoma

Intervention(s)

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

Primary Outcome(s)

Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [Time Frame: 8 weeks]

Secondary Outcome(s)

Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [Time Frame: 16 weeks]

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

Secondary ID(s)

R-GEMOX

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche

Sanofi-Synthelabo

Eli Lilly and Company