Trial Information

A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma

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.