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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHA Hôpital de l'Enfant-JésusRecruiting
  • CHUS Hopital FleurimontRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin

Arm Description

oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma

Outcomes

Primary Outcome Measures

Response rate to RGDOx in patients with relapsing or refractory NHL

Secondary Outcome Measures

Full Information

First Posted
November 24, 2009
Last Updated
January 11, 2011
Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT01019863
Brief Title
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Acronym
LNH-RGDOX
Official Title
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin
Arm Type
Experimental
Arm Description
oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles
Primary Outcome Measure Information:
Title
Response rate to RGDOx in patients with relapsing or refractory NHL
Time Frame
Within 3 months after chemotherapy (6-8 cycles)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years or above at the time of inclusion. Documented CD20+ NHL, refractory or relapsing after first line chemotherapy. No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab. Exclusion Criteria: Other types of non-Hodgkin lymphoma Pregnancy and lactation. Patient unable to give written informed consent. Contra-indication ou intolerance to any of the components of the RGDOx chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anick Champoux, RN
Phone
819-346-1110
Ext
12811
Email
achampoux.chus@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Kotb, MD
Organizational Affiliation
CHUS Hopital Fleurimont
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Hôpital de l'Enfant-Jésus
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Vallée, RN
Phone
418-649-0252
Ext
3115
Email
linda.vallee.cha@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Jean-François Larouche, MD
Facility Name
CHUS Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anick Champoux, Research coordinator
Phone
819-346-1110
Ext
12811
Email
achampoux.chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Rami Kotb, MD

12. IPD Sharing Statement

Learn more about this trial

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

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