Non-Hodgkin LymphomaPhase 2LNH-RGDOXNCT01019863
Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
A Phase 2 study testing oxaliplatin in people with Non-Hodgkin Lymphoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2008to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
CHA Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Linda Vallée, RN, 418-649-0252 ext. 3115, linda.vallee.cha@ssss.gouv.qc.ca
Jean-François Larouche, MD
- Recruiting
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Anick Champoux, Research coordinator, 819-346-1110 ext. 12811, achampoux.chus@ssss.gouv.qc.ca
Rami Kotb, MD
About this study
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
- Being tested
- oxaliplatin
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Oxaliplatin | Experimental | oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma Receives: Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to RGDOx in patients with relapsing or refractory NHL
Measured: Within 3 months after chemotherapy (6-8 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2010 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Investigators
- Rami Kotb, MD, Principal investigator, CHUS Hopital Fleurimont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019863
- Sponsor's protocol ID
- 122752
- Acronym
- LNH-RGDOX
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate an Oxaliplatin-based Chemotherapy in Patients With Resistant or Relapsing Non-Hodgkin Lymphoma.
- ClinicalTrials.gov ID
- NCT01019863
- Acronym / sponsor ID
- LNH-RGDOX / 122752
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxaliplatin | Experimental | Drug: oxaliplatinoxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatinoxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles | Drug | Oxaliplatin |
Primary outcome
Response rate to RGDOx in patients with relapsing or refractory NHL
Time frame: Within 3 months after chemotherapy (6-8 cycles)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rami Kotb, MD principal investigator
CHUS Hopital Fleurimont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin in people with Non-Hodgkin Lymphoma, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anick Champoux, RN (819-346-1110 ext. 12811, achampoux.chus@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate to RGDOx in patients with relapsing or refractory NHL (time frame: Within 3 months after chemotherapy (6-8 cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.