A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim (VGF)/Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine (F-GIV) Salvage Therapies in the treatment of Relapsed/Refractory CD20+ Lymphomas.
A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim or Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine Salvage Therapies in the Treatment of Relapsed/Refractory CD20+ Non-Hodgkin Lymphomas to Improve the Outcome of Quality of Life and to Minimise Inpatient Stay.
Associate Professor Andrew Spencer
12 participants
Mar 3, 2006
Interventional
Conditions
Summary
The purpose of this study is to evaluate the effectiveness and safety of a new outpatient chemotherapy treatment for relapsed or treatment resistant (refractory) lymphoma.
Eligibility
Inclusion Criteria1
- Relapsed or primary refractory CD20+ NHL, ECOG 0 – 2, Written informed consent.
Exclusion Criteria1
- 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.
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Interventions
This is an open label, Phase II, pilot study of 12 patients using a risk-adjusted outpatient-based approach to non- Hodgkin Lymphoma salvage therapy with R-VGF (Rituximab 375mg/m2 IV, Vinorelbine 25mg/m2 IV, Gemcitabine 1000mg/m2 IV and Pegfilgrastim 6mg subcutaneous) and R-F-GIV (Rituximab 375mg/m2 IV, Gemcitabine 1000mg/m2 IV, Ifosfamide 3g/m2 IV, Vinorelbine 25mg/m2 IV and Pegfilgrastim 6mg subcutaneous. Patients will be stratified at the time of accrual to 1 of 3 groups: Good risk (Group 1), poor risk (Group 2) or post-transplant (Group 3). Patients in Groups 1 and 3 will commence treatment with R-VGF. Patients in Group 2 will commence treatment with R-F-GIV. Patients failing to show an adequate response following 2 cycles of therapy and who do not have progressive disease will escalate to a more intensive regimen for 2 further cycles of therapy (R-VGF to R-F-GIV, R-F-GIV to IVAC). IVAC comprises Etoposide 60mg/m2 IV and Ifosfamide 1.5g/m2 IV given on Day 1 to 5, Cytarabine 2g/m2 IV given on Day 1 and 2 and Pegfilgrastim 6mg subcutaneous given on Day 6 of each 21 Day cycle. The pegylated form of Filgrastim, Pegfilgrastim, will be used once per cycle instead of daily Filgrastim. Patients will receive treatment on Day 1 and 8 of every 3 week cycle.
Locations(1)
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ACTRN12606000386538