Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma

This study has been completed.
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: January 6, 2016
Last verified: January 2016
This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Drug: gemcitabine, vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.

Resource links provided by NLM:

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).

Secondary Outcome Measures:
  • To evaluate the requirement for inpatient admission and / or parenteral antibiotic therapy following study treatment in an outpatient setting.

Estimated Enrollment: 40
Study Start Date: February 2001
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:
Patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. The standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. However, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18 to 70 years
  • relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
  • measurable disease (clinically or radiologically)
  • ECOG 0 - 2
  • written informed consent

Exclusion criteria:

  • 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
  • isolated bone marrow disease
  • known sensitivity to E coli derived preparations
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00163748

Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Study Chair: Andrew Spencer, Assoc. Prof
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00163748     History of Changes
Other Study ID Numbers: AH152/00 
Study First Received: September 12, 2005
Last Updated: January 6, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:

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

ClinicalTrials.gov processed this record on May 24, 2016