gemcitabine, vinorelbine, ifosfamide, filgastrim
DrugDrug
NCT Number: NCT00163761
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Canberra Hospital, Canberra, Australian Capital Territory, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug
Drug
Time frame: After two cycles and after four cycles
Time frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
Time frame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
Time frame: every 3 or 4 months for 12 months. Then every 6 months.
Time frame: After two cycles and after four cycles
Bayside Health
Other Gov
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
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