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Efficacy Study of Outpatient Therapy for Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163761
First received: September 11, 2005
Last updated: January 6, 2016
Last verified: January 2016
  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, filgastrim
Drug: gemcitabine, vinorelbine, filgastrim
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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). [ Time Frame: After two cycles and after four cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety, [ Time Frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle. ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • overall survival, [ Time Frame: every 3 or 4 months for 12 months. Then every 6 months. ] [ Designated as safety issue: No ]
  • and planned dose-on-time. [ Time Frame: After two cycles and after four cycles ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: December 2002
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Monash Medical Centre
Melbourne, Victoria, Australia, 3199
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Bayside Health
Investigators
Study Chair: Andrew Spencer, Assoc. Prof
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163761     History of Changes
Other Study ID Numbers: AH226/02 
Study First Received: September 11, 2005
Last Updated: January 6, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Vinorelbine
Isophosphamide mustard
Vinblastine
Ifosfamide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 29, 2016