NCT00163761

Brief Summary

This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

Geographic Reach
1 country

10 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

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

5.2 years

First QC Date

September 11, 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 (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).

    After two cycles and after four cycles

Secondary Outcomes (4)

  • To evaluate safety,

    Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.

  • relapse free survival,

    After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression

  • overall survival,

    every 3 or 4 months for 12 months. Then every 6 months.

  • and planned dose-on-time.

    After two cycles and after four cycles

Study Arms (2)

Commence VGF treatment

ACTIVE COMPARATOR

Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle

Drug: gemcitabine, vinorelbine, filgastrim

Commence F-GIV treatment

ACTIVE COMPARATOR

Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle

Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim

Interventions

gemcitabine, vinorelbine, ifosfamide, filgastrimDRUG

Drug

Commence F-GIV treatment
gemcitabine, vinorelbine, filgastrimDRUG

Drug

Commence VGF treatment

Eligibility Criteria

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

You may qualify if:

  • age \> 18 years
  • relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
  • ECOG 0 - 2
  • written informed consent

You may not qualify if:

  • Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy
  • 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
  • relapse within 6 months of a prior transplant procedure (autologous or allogeneic)
  • known sensitivity to E coli derived preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Frankston Hospital

Melbourne, Victoria, 3199, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3199, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseLymphoma

Interventions

GemcitabineVinorelbineIfosfamide

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-RingIndolizidinesIndolizinesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazines

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
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

December 1, 2002

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

AU(10)