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

November 24, 2009
January 11, 2011
October 2008
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01019863 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin Lymphoma
Drug: oxaliplatin
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles
Experimental: Oxaliplatin
oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma
Intervention: Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Anick Champoux, RN 819-346-1110 ext 12811 achampoux.chus@ssss.gouv.qc.ca
Canada
 
NCT01019863
122752
Yes
Dr Rami Kotb, hematologist, CHUS Hopital Fleurimont
Centre Hospitalier Universitaire de Sherbrooke
Not Provided
Principal Investigator: Rami Kotb, MD CHUS Hopital Fleurimont
Centre Hospitalier Universitaire de Sherbrooke
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP