NCT01019863

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 12, 2011

Status Verified

November 1, 2009

Enrollment Period

2 years

First QC Date

November 24, 2009

Last Update Submit

January 11, 2011

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response rate to RGDOx in patients with relapsing or refractory NHL

    Within 3 months after chemotherapy (6-8 cycles)

Study Arms (1)

Oxaliplatin

EXPERIMENTAL

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

Drug: oxaliplatin

Interventions

oxaliplatinDRUG

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

Oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented CD20+ NHL, refractory or relapsing after first line chemotherapy.
  • No contraindication to Oxaliplatin, Gemcitabine, Dexamethasone or Rituximab.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHA Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

CHUS Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Rami Kotb, MD

    CHUS Hopital Fleurimont

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anick Champoux, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

January 12, 2011

Record last verified: 2009-11

Locations

CA(2)