Know Cancer

forgot password

A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

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

Thank you

Trial Information

A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Principal Investigator

Andrew Spencer, Assoc. Prof

Investigator Role:

Study Chair


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

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