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A Pilot Study of Rituximab in Combination With Out-Patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas

Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma (CD20+)

Thank you

Trial Information

A Pilot Study of Rituximab in Combination With Out-Patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas

Recent epidemiologic surveys have demonstrated a dramatic increase in the incidence of
non-Hodgkin's lymphoma (NHL). NHL is now one of the most rapidly increasing malignancies in
the industrial world.

The purpose of this project is to evaluate the efficacy and safety of an outpatient
treatment for relapsed or treatment resistant (refractory) CD20+ lymphoma. Two combinations
of chemotherapy drugs will be tested depending on the patients prior therapy and response -
rituximab, vinorelbine and gemcitabine (R-VGF) OR rituximab, vinorelbine, gemcitabine and
ifosfamide (R-FGIV).

Previous experience, including a recently completed study using combinations of vinorelbine,
gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of
similar efficacy to presently available alternative inpatient chemotherapy approaches. This
study is expanding on the findings from the previous study by adding rituximab.

Rituximab is being increasingly and successfully used in the therapy of CD20+ NHL. It is a
specific protein (antibody) that is directed against the surface protein (CD20 antigen)
found on CD20+ lymphoma cells and can therefore lead to the destruction of these cells.
Rituximab also has a highly favourable toxicity profile enabling outpatient treatment.

All of these factors provide a strong rationale for the combination of rituximab and the
novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated.
This pilot study of 12 patients will test the feasibility of this combination approach in
patients with relapsed/refractory CD20+ NHL.

Inclusion Criteria:

- Age >18 years

- Relapsed or primary refractory CD20+ NHL

- 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 > 50┬Ámol/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: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF and/or F-GIV in combination with Rituximab.

Principal Investigator

Andrew Spencer, Assoc.Prof

Investigator Role:

Study Chair


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2006

Completion Date:

September 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma (CD20+)
  • Lymphoma
  • CD20+
  • Lymphoma
  • Lymphoma, Non-Hodgkin