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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Centre Hospitalier Universitaire de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01019863
First received: November 24, 2009
Last updated: January 11, 2011
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkin Lymphoma
 Drug: oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Response rate to RGDOx in patients with relapsing or refractory NHL [ Time Frame: Within 3 months after chemotherapy (6-8 cycles) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitalier Universitaire de Sherbrooke
Investigators
Principal Investigator: Rami Kotb, MD CHUS Hopital Fleurimont
  More Information

No publications provided

Responsible Party: Dr Rami Kotb, hematologist, CHUS Hopital Fleurimont
ClinicalTrials.gov Identifier: NCT01019863     History of Changes
Other Study ID Numbers: 122752
Study First Received: November 24, 2009
Last Updated: January 11, 2011
Health Authority: Canada: Health Canada

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013