- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01019863
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma. (LNH-RGDOX)
January 11, 2011 updated by: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anick Champoux, RN
- Phone Number: 12811 819-346-1110
- Email: achampoux.chus@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1J 1Z4
- Recruiting
- CHA Hôpital de l'Enfant-Jésus
-
Contact:
- Linda Vallée, RN
- Phone Number: 3115 418-649-0252
- Email: linda.vallee.cha@ssss.gouv.qc.ca
-
Principal Investigator:
- Jean-François Larouche, MD
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- CHUS Hopital Fleurimont
-
Contact:
- Anick Champoux, Research coordinator
- Phone Number: 12811 819-346-1110
- Email: achampoux.chus@ssss.gouv.qc.ca
-
Principal Investigator:
- Rami Kotb, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oxaliplatin
oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma
|
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate to RGDOx in patients with relapsing or refractory NHL
Time Frame: Within 3 months after chemotherapy (6-8 cycles)
|
Within 3 months after chemotherapy (6-8 cycles)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rami Kotb, MD, CHUS Hopital Fleurimont
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
October 1, 2010
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
November 24, 2009
First Submitted That Met QC Criteria
November 24, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
January 12, 2011
Last Update Submitted That Met QC Criteria
January 11, 2011
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122752
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Hodgkin Lymphoma
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
-
Marker Therapeutics, Inc.RecruitingNon Hodgkin Lymphoma | Non-Hodgkin Lymphoma, Adult | Non-Hodgkin Lymphoma, Refractory | Non-Hodgkin Lymphoma, RelapsedUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
National Cancer Institute (NCI)RecruitingRefractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Transformed Non-Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous... and other conditionsUnited States
-
Caribou Biosciences, Inc.RecruitingLymphoma | Lymphoma, Non-Hodgkin | B Cell Lymphoma | Non Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Relapsed Non Hodgkin Lymphoma | B Cell Non-Hodgkin's LymphomaUnited States, Australia, Israel
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRefractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Hematopoietic Cell Transplantation RecipientUnited States
-
Chongqing Precision Biotech Co., LtdRecruitingNon Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Relapsed Non-Hodgkin LymphomaChina
-
Estrella Biopharma, Inc.Eureka Therapeutics Inc.Not yet recruitingLymphoma | Lymphoma, Non-Hodgkin | Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | High-grade B-cell Lymphoma | CNS Lymphoma | Lymphomas Non-Hodgkin's B-Cell | Relapsed Non-Hodgkin Lymphoma | Lymphoma, Non-Hodgkins | Large B-Cell Lymphoma and other conditions
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRefractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma | Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma | Refractory Cutaneous T-Cell Non-Hodgkin LymphomaUnited States
-
University of WashingtonRecruitingRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin LymphomaUnited States
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-
Xijing HospitalUnknownGastrointestinal CancerChina
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Lin ChenUnknownGastric AdenocarcinomaChina
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Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Chonnam National University... and other collaboratorsCompletedColorectal CancerKorea, Republic of
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical CancerUnited States, Canada
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States
-
St. Jude Children's Research HospitalNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol SpecificUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisNational Cancer Institute, FranceSuspended
-
University of ChicagoNational Cancer Institute (NCI)CompletedBladder Cancer | Transitional Cell Cancer of the Renal Pelvis and UreterUnited States, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedEndometrial CancerUnited States