Efficacy Study of Outpatient Therapy for Lymphoma
Information source: Bayside Health
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin's Lymphoma; Hodgkin's Disease
Intervention: gemcitabine, vinorelbine, ifosfamide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayside Health Official(s) and/or principal investigator(s):
Andrew Spencer, Assoc. Prof, Study Chair, Affiliation: Unaffiliated
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.
Clinical Details
Official title:
A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
Primary outcome: To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
Secondary outcome: To evaluate safety,relapse free survival, overall survival, and planned dose-on-time.
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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia
Royal North Shore Hospital, Sydney, New South Wales 2065, Australia
Mater Adult Hospital, South Brisbane, Queensland 4101, Australia
Royal Hobart Hospital, Hobart, Tasmania 7001, Australia
The Alfred Hospital, Melbourne, Victoria 3004, Australia
The Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia
Border Medical Oncology, Wodonga, Victoria 3690, Australia
Frankston Hospital, Melbourne, Victoria 3199, Australia
Monash Medical Centre, Melbourne, Victoria 3199, Australia
Fremantle Hospital, Fremantle, Western Australia 6160, Australia
Additional Information
Starting date:
December 2002
Last updated: September 11, 2005
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