NCT00169195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

9.6 years

First QC Date

September 12, 2005

Last Update Submit

September 1, 2015

Conditions

Diffuse Large Cell Lymphoma

Keywords

B-cell lymphomaSalvage Therapyrituximaboxaliplatinegemcitabine

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])

    4 cycles of R-GEMOX

    8 weeks

Secondary Outcomes (2)

  • Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])

    16 weeks

  • Event free survival (EFS)

    2 years

Study Arms (1)

R-GEMOX

EXPERIMENTAL

Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

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

Interventions

Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)DRUG
R-GEMOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with histologically or cytologically proven, CD 20+, diffuse large B-cell lymphoma,
  • 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

You may not qualify if:

  • 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
  • Pregnant or lactating woman
  • Adult patient unable to give informed consent because of intellectual impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hôpital Henri Mondor

Créteil, France

Location

Service d'Hématologie Clinique - CHU Le Bocage

Dijon, France

Location

Service des Maladies du Sang - CHRU de Lille

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital Saint Louis

Paris, France

Location

Service D'Hématologie Adulte - Hôpital Necker

Paris, France

Location

Centre Henri Becquerel

Rouen, France

Location

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Location

Related Publications (6)

  • 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.

    PMID: 11807147BACKGROUND

  • 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.

    PMID: 11843810BACKGROUND

  • 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.

    PMID: 11762817BACKGROUND

  • 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.

    PMID: 10412945BACKGROUND

  • 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.

    PMID: 10907954BACKGROUND

  • 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.

    PMID: 23753028DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, B-Cell

Interventions

gemcitabine-oxaliplatin regimenRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Corinne Haioun, MD

    Hôpital Henri Mondor, Créteil, France

    STUDY CHAIR

  • Corinne Haioun, MD

    Hôpital henri Mondor, Créteil, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2003

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

FR(8)