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Efficacy Study of Outpatient Therapy for Lymphoma
This study has been completed.
First Received: September 11, 2005   No Changes Posted
Sponsors and Collaborators: Bayside Health
Investigator initiated study
Information provided by: Bayside Health
ClinicalTrials.gov Identifier: NCT00163761
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Drug: gemcitabine, vinorelbine, ifosfamide
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Official Title: A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • To evaluate safety,
  • relapse free survival,
  • overall survival,
  • and planned dose-on-time.

Estimated Enrollment: 90
Study Start Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163761

Locations
Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Queensland
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Monash Medical Centre
Melbourne, Victoria, Australia, 3199
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Bayside Health
Investigator initiated study
Investigators
Study Chair: Andrew Spencer, Assoc. Prof Unaffiliated
  More Information

No publications provided

Study ID Numbers: AH226/02
Study First Received: September 11, 2005
Last Updated: September 11, 2005
ClinicalTrials.gov Identifier: NCT00163761     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
Lymphoma

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Immunoproliferative Disorders
Immunologic Factors
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Immunosuppressive Agents
Antiviral Agents
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Ifosfamide
Vinorelbine
Radiation-Sensitizing Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Gemcitabine
Antineoplastic Agents, Phytogenic
Lymphoma
Hodgkin Disease
Isophosphamide mustard

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Therapeutic Uses
Gemcitabine
Lymphoma
Hodgkin Disease
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009