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Efficacy Study of Outpatient Therapy for Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163761
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Hodgkin's Disease Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim Drug: gemcitabine, vinorelbine, filgastrim Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2002
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: Commence VGF treatment
Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
Drug: gemcitabine, vinorelbine, filgastrim

Active Comparator: Commence F-GIV treatment
Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle
Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim

Primary Outcome Measures :
  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). [ Time Frame: After two cycles and after four cycles ]

Secondary Outcome Measures :
  1. To evaluate safety, [ Time Frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle. ]
  2. 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 ]
  3. overall survival, [ Time Frame: every 3 or 4 months for 12 months. Then every 6 months. ]
  4. and planned dose-on-time. [ Time Frame: After two cycles and after four cycles ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163761

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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
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Study Chair: Andrew Spencer, Assoc. Prof
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Responsible Party: Bayside Health Identifier: NCT00163761    
Other Study ID Numbers: AH226/02
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by Bayside Health:
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
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