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Diffuse Large Cell LymphomaPhase 2NCT00169195

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

A Phase 2 study testing Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX) in people with Diffuse Large Cell Lymphoma, run by Lymphoma Study Association at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large Cell Lymphoma
What is being tested?
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
8 sitesFrance
Study dates
Apr 2003to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Hôpital Henri Mondor

    Créteil

  • Service d'Hématologie Clinique - CHU Le Bocage

    Dijon

  • Service des Maladies du Sang - CHRU de Lille

    Lille

  • Centre Léon Bérard

    Lyon

  • Hôpital Saint Louis

    Paris

  • Service D'Hématologie Adulte - Hôpital Necker

    Paris

  • Centre Henri Becquerel

    Rouen

  • CHRU de Nancy Brabois

    Vandœuvre-lès-Nancy

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Keywords
B-cell lymphoma, Salvage Therapy, rituximab, oxaliplatine, gemcitabine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00169195
Study groupRoleWhat they receive
R-GEMOXExperimentalGemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Receives: Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    4 cycles of R-GEMOX

    Measured: 8 weeks

Secondary outcomes (2)

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

    completion of the treatment

    Measured: 16 weeks

  2. Event free survival (EFS)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169195
Sponsor's protocol ID
R-GEMOX
Status last verified
Sep 2015
First submitted
12 Sep 2005
Last updated
2 Sep 2015
Results posted
No

Publications

  • 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.

    PubMed 11807147

  • 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.

    PubMed 11843810

  • 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.

    PubMed 11762817

  • 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.

    PubMed 10412945

  • 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.

    PubMed 10907954

  • 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.

    PubMed 23753028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX) in people with Diffuse Large Cell Lymphoma, run by Lymphoma Study Association at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169195, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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