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

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01019863
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 36
• Patients Per Site: 25
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2010
• Anticipated Study Completion Date: Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHA Hôpital de l'Enfant-Jésus	Québec	Quebec	Canada	G1J 1Z4
2	CHUS Hopital Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Investigators

• Principal Investigator: Rami Kotb, MD, CHUS Hopital Fleurimont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01019863
• Other Study ID Numbers: 122752
• First Posted: Nov 25, 2009
• Last Update Posted: Jan 12, 2011
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Oxaliplatin

Study Results

No Results Posted as of Jan 12, 2011