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A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.

Phase 2
18 Years
70 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Hodgkin's Disease

Thank you

Trial Information

A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).

Principal Investigator

Andrew Spencer, Assoc. Prof

Investigator Role:

Study Chair


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

February 2001

Completion Date:

November 2003

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin