NCT00163748

Brief Summary

This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2001

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2001

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Last Update Submit

January 6, 2016

Conditions

Non-Hodgkin's LymphomaHodgkin's Disease

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).

Secondary Outcomes (1)

  • To evaluate the requirement for inpatient admission and / or parenteral antibiotic therapy following study treatment in an outpatient setting.

Interventions

gemcitabine, vinorelbineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 to 70 years
  • relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
  • measurable disease (clinically or radiologically)
  • ECOG 0 - 2
  • written informed consent

You may not qualify if:

  • bilirubin \> 50μmol/litre unless secondary to lymphoma
  • creatinine \> 2 x upper limit of normal unless secondary to lymphoma,
  • absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma
  • isolated bone marrow disease
  • known sensitivity to E coli derived preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseLymphoma

Interventions

GemcitabineVinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Andrew Spencer, Assoc. Prof

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

February 1, 2001

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

AU(2)