Status:
COMPLETED
Efficacy Study of Outpatient Therapy for Lymphoma
Lead Sponsor:
Bayside Health
Conditions:
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or...
Detailed Description
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 availa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00163761
Start Date
December 1 2002
End Date
February 1 2008
Last Update
January 8 2016
Active Locations (10)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
2
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
3
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
4
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001