Study to Evaluate an Oxaliplatin-based Chemotherapy in Pa... | NCT01019863

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

NCT01019863

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status

Unknown status

Last Update Posted

Jan 12, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Non-Hodgkin Lymphoma

Interventions

oxaliplatin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxaliplatin	Experimental	oxaliplatin associated with Rituxan,Gemcitabine, and Dexamethasone in patients with refractory or relapsed Non hodgkinien lymphoma	Drug: oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxaliplatin	Drug	oxaliplatin 100mg/m2 + Rituxan 375 mg/m2 + Gemcitabine 1000mg/m2 every 2 weeks for 8 cycles	Oxaliplatin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anick Champoux, RN	Contact	819-346-1110	12811	achampoux.chus@ssss.gouv.qc.ca

Overall Officials

Name	Affiliation	Role
Rami Kotb, MD	CHUS Hopital Fleurimont	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHA Hôpital de l'Enfant-Jésus	Recruiting	Québec	Quebec	G1J 1Z4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided