Efficacy Study of Outpatient Therapy for Lymphoma

January 6, 2016 updated by: Bayside Health

A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3199
        • Frankston Hospital
      • Melbourne, Victoria, Australia, 3199
        • Monash Medical Centre
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Commence VGF treatment
Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
Drug: gemcitabine, vinorelbine, filgastrim
Drug
Active Comparator: Commence F-GIV treatment
Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle
Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim
Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: After two cycles and after four cycles
After two cycles and after four cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety,
Time Frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
relapse free survival,
Time Frame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
overall survival,
Time Frame: every 3 or 4 months for 12 months. Then every 6 months.
every 3 or 4 months for 12 months. Then every 6 months.
and planned dose-on-time.
Time Frame: After two cycles and after four cycles
After two cycles and after four cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Investigators

  • Study Chair: Andrew Spencer, Assoc. Prof

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH226/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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