Status:
COMPLETED
Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma
Lead Sponsor:
Bayside Health
Conditions:
Non-Hodgkin's Lymphoma (CD20+)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcit...
Detailed Description
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....
Eligibility Criteria
Inclusion
- Age \>18 years
- Relapsed or primary refractory CD20+ NHL
- ECOG 0 - 2
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00280878
Start Date
January 1 2006
End Date
September 1 2007
Last Update
January 15 2016
Active Locations (2)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
2
Frankston Hospital
Melbourne, Victoria, Australia