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Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma. (LNH-RGDOX)

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ClinicalTrials.gov Identifier: NCT01019863
Recruitment Status : Unknown
Verified November 2009 by Centre de recherche du Centre hospitalier universitaire de Sherbrooke.
Recruitment status was:  Recruiting
First Posted : November 25, 2009
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:
Evaluation of the efficacy, tolerance, quality of life and cost effectiveness of the association of Oxaliplatin, Gemcitabine, Rituximab and Dexamethasone for treatment of patients with refractory or relapsing non-Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Study Start Date : October 2008
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Oxaliplatin
oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma
Drug: oxaliplatin
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles




Primary Outcome Measures :
  1. Response rate to RGDOx in patients with relapsing or refractory NHL [ Time Frame: Within 3 months after chemotherapy (6-8 cycles) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years or above at the time of inclusion.
  2. Documented CD20+ NHL, refractory or relapsing after first line chemotherapy.
  3. No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab.

Exclusion Criteria:

  1. Other types of non-Hodgkin lymphoma
  2. Pregnancy and lactation.
  3. Patient unable to give written informed consent.
  4. Contra-indication ou intolerance to any of the components of the RGDOx chemotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019863


Contacts
Contact: Anick Champoux, RN 819-346-1110 ext 12811 achampoux.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
CHA Hôpital de l'Enfant-Jésus Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Linda Vallée, RN    418-649-0252 ext 3115    linda.vallee.cha@ssss.gouv.qc.ca   
Principal Investigator: Jean-François Larouche, MD         
CHUS Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Anick Champoux, Research coordinator    819-346-1110 ext 12811    achampoux.chus@ssss.gouv.qc.ca   
Principal Investigator: Rami Kotb, MD         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Investigators
Principal Investigator: Rami Kotb, MD CHUS Hopital Fleurimont

Responsible Party: Dr Rami Kotb, hematologist, CHUS Hopital Fleurimont
ClinicalTrials.gov Identifier: NCT01019863     History of Changes
Other Study ID Numbers: 122752
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Oxaliplatin
Antineoplastic Agents