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Brief Title: Efficacy Study of Outpatient Therapy for Lymphoma
Official Title: A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
Study ID: NCT00163761
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 gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
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 available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Canberra Hospital, Canberra, Australian Capital Territory, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Mater Adult Hospital, South Brisbane, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
The Royal Melbourne Hospital, Melbourne, Victoria, Australia
Frankston Hospital, Melbourne, Victoria, Australia
Monash Medical Centre, Melbourne, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Fremantle Hospital, Fremantle, Western Australia, Australia
Name: Andrew Spencer, Assoc. Prof
Affiliation:
Role: STUDY_CHAIR