Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
NCT ID: NCT00169195
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2003-04-30
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R-GEMOX
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Interventions
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Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Sanofi-Synthelabo
INDUSTRY
Eli Lilly and Company
INDUSTRY
Lymphoma Study Association
OTHER
Responsible Party
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Principal Investigators
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Corinne Haioun, MD
Role: STUDY_CHAIR
Hôpital Henri Mondor, Créteil, France
Corinne Haioun, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital henri Mondor, Créteil, France
Locations
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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
Hôpital Saint Louis
Paris, , France
Service D'Hématologie Adulte - Hôpital Necker
Paris, , France
Centre Henri Becquerel
Rouen, , France
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
Chau I, Webb A, Cunningham D, Hill M, Rao S, Ageli S, Norman A, Gill K, Howard A, Catovsky D. An oxaliplatin-based chemotherapy in patients with relapsed or refractory intermediate and high-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Dec;115(4):786-92. doi: 10.1046/j.1365-2141.2001.03181.x.
Machover D, Delmas-Marsalet B, Misra SC, Gumus Y, Goldschmidt E, Schilf A, Frenoy N, Emile JF, Debuire B, Guettier C, Farrokhi P, Boulefdaoui B, Norol F, Parquet N, Ulusakarya A, Jasmin C. Dexamethasone, high-dose cytarabine, and oxaliplatin (DHAOx) as salvage treatment for patients with initially refractory or relapsed non-Hodgkin's lymphoma. Ann Oncol. 2001 Oct;12(10):1439-43. doi: 10.1023/a:1012501305214.
Faivre S, Raymond E, Woynarowski JM, Cvitkovic E. Supraadditive effect of 2',2'-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol. 1999;44(2):117-23. doi: 10.1007/s002800050955.
Savage DG, Rule SA, Tighe M, Garrett TJ, Oster MW, Lee RT, Ruiz J, Heitjan D, Keohan ML, Flamm M, Johnson SA. Gemcitabine for relapsed or resistant lymphoma. Ann Oncol. 2000 May;11(5):595-7. doi: 10.1023/a:1008307528519.
Mounier N, El Gnaoui T, Tilly H, Canioni D, Sebban C, Casasnovas RO, Delarue R, Sonet A, Beaussart P, Petrella T, Castaigne S, Bologna S, Salles G, Rahmouni A, Gaulard P, Haioun C. Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II Lymphoma Study Association trial. Haematologica. 2013 Nov;98(11):1726-31. doi: 10.3324/haematol.2013.090597. Epub 2013 Jun 10.
Related Links
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Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)
Other Identifiers
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R-GEMOX
Identifier Type: -
Identifier Source: org_study_id
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