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

Primary Purpose

Diffuse Large Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large Cell Lymphoma focused on measuring B-cell lymphoma, Salvage Therapy, rituximab, oxaliplatine, gemcitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital Henri Mondor
  • Service d'Hématologie Clinique - CHU Le Bocage
  • Service des Maladies du Sang - CHRU de Lille
  • Centre Léon Bérard
  • Hôpital Saint Louis
  • Service D'Hématologie Adulte - Hôpital Necker
  • Centre Henri Becquerel
  • CHRU de Nancy Brabois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-GEMOX

Arm Description

Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
completion of the treatment
Event free survival (EFS)

Full Information

First Posted
September 12, 2005
Last Updated
September 1, 2015
Sponsor
Lymphoma Study Association
Collaborators
Hoffmann-La Roche, Sanofi-Synthelabo, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00169195
Brief Title
Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lymphoma Study Association
Collaborators
Hoffmann-La Roche, Sanofi-Synthelabo, Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large Cell Lymphoma
Keywords
B-cell lymphoma, Salvage Therapy, rituximab, oxaliplatine, gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-GEMOX
Arm Type
Experimental
Arm Description
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Primary Outcome Measure Information:
Title
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
Description
4 cycles of R-GEMOX
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
Description
completion of the treatment
Time Frame
16 weeks
Title
Event free survival (EFS)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, MD
Organizational Affiliation
Hôpital Henri Mondor, Créteil, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, MD
Organizational Affiliation
Hôpital henri Mondor, Créteil, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Service d'Hématologie Clinique - CHU Le Bocage
City
Dijon
Country
France
Facility Name
Service des Maladies du Sang - CHRU de Lille
City
Lille
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Service D'Hématologie Adulte - Hôpital Necker
City
Paris
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
CHRU de Nancy Brabois
City
Vandoeuvre les Nancy
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11807147
Citation
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.
Results Reference
background
PubMed Identifier
11843810
Citation
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.
Results Reference
background
PubMed Identifier
11762817
Citation
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.
Results Reference
background
PubMed Identifier
10412945
Citation
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.
Results Reference
background
PubMed Identifier
10907954
Citation
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.
Results Reference
background
PubMed Identifier
23753028
Citation
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.
Results Reference
derived
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

Learn more about this trial

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

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