Efficacy Study of Outpatient Therapy for Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163761
• Other study ID #: AH226/02
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: January 6, 2016
• Start date: December 2002
• Est. completion date: February 2008

Study information

• Verified date: January 2016
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• gemcitabine, vinorelbine, ifosfamide, filgastrim
Drug
• gemcitabine, vinorelbine, filgastrim
Drug

Locations

Country	Name	City	State
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Frankston Hospital	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Border Medical Oncology	Wodonga	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		After two cycles and after four cycles	No
Secondary	To evaluate safety,		Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.	Yes
Secondary	relapse free survival,		After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression	No
Secondary	overall survival,		every 3 or 4 months for 12 months. Then every 6 months.	No
Secondary	and planned dose-on-time.		After two cycles and after four cycles	No