Efficacy Study of Outpatient Therapy for Lymphoma

Bayside Health

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Hodgkin's Disease

Treatments

Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim

Drug: gemcitabine, vinorelbine, filgastrim

Study type

Interventional

Funder types

Other

Identifiers

NCT00163761

AH226/02

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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