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.
Phase 2
Completed
- Conditions
- Relapsed and refractory CD20+ lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
- Registration Number
- ACTRN12606000386538
- Lead Sponsor
- Associate Professor Andrew Spencer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
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 > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety 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) in combination with Rituximab (R-VGF/R-F-GIV). <br>A 20% rate of Grade 4 non-haematological toxicity would be considered excessive. Treatment with protocol therapy will be terminated if 4 out of the first 10 patients treated experience at least 1 Grade 4 non-haematological toxicity. All patients who receive any study medication will be included in the toxicity analysis.[Patients will be assessed after each cycle of treatment.]
- Secondary Outcome Measures
Name Time Method To determine point estimates of the response rates achieved with R-VGF or R-F-GIV in previously treated patients with relapsed/refractory CD20+ B-cell NHL.[ An intention to treat analysis of response will be conducted including all patients receiving any protocol medication. Response assessment will be performed post 2 cycles of treatment and again after the completion of 4 cycles of treatment.]