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Trial Title:
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
NCT ID:
NCT01019863
Condition:
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
oxaliplatin
Description:
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8
cycles
Arm group label:
Oxaliplatin
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHA Hôpital de l'Enfant-Jésus
Address:
City:
Québec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Linda Vallée, RN
Phone:
418-649-0252
Phone ext:
3115
Email:
linda.vallee.cha@ssss.gouv.qc.ca
Investigator:
Last name:
Jean-François Larouche, MD
Email:
Principal Investigator
Facility:
Name:
CHUS Hopital Fleurimont
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Anick Champoux, Research coordinator
Phone:
819-346-1110
Phone ext:
12811
Email:
achampoux.chus@ssss.gouv.qc.ca
Investigator:
Last name:
Rami Kotb, MD
Email:
Principal Investigator
Start date:
October 2008
Completion date:
October 2011
Lead sponsor:
Agency:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Agency class:
Other
Source:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01019863
