Recruiting
Phase 2

Oxaliplatin Chemotherapy

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT01019863

Conditions

Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

oxaliplatin

Study Details

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.

Conditions

Non-Hodgkin Lymphoma

Study ID

NCT01019863

Start date

Oct, 2008

Status verified date

Nov, 2009

Completion date

Oct, 2011

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxaliplatin

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

Interventions

oxaliplatin

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anick Champoux, RN

819-346-1110achampoux.chus@ssss.gouv.qc.ca

Locations

CHA Hôpital de l'Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Linda Vallée, RN

418-649-0252linda.vallee.cha@ssss.gouv.qc.ca

Principal Investigator:

Jean-François Larouche, MD

CHUS Hopital Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Anick Champoux, Research coordinator

819-346-1110achampoux.chus@ssss.gouv.qc.ca

Principal Investigator:

Rami Kotb, MD

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Jan 12, 2011

Last verified

Nov, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2011-01-12.