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

Non-Hodgkin Lymphoma Clinical Trial

— LNH-RGDOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01019863
• Other study ID #: 122752
• Status: Recruiting
• Phase: Phase 2
• First received: November 24, 2009
• Last updated: January 11, 2011
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: November 2009
• Source: Centre Hospitalier Universitaire de Sherbrooke
• Contact: Anick Champoux, RN
• Phone: 819-346-1110
• Email: achampoux.chus[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• oxaliplatin
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles

Locations

Country	Name	City	State
Canada	CHA Hôpital de l'Enfant-Jésus	Québec	Quebec
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate to RGDOx in patients with relapsing or refractory NHL		Within 3 months after chemotherapy (6-8 cycles)	Yes