Efficacy Study of Outpatient Therapy for Lymphoma

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Disease
• Interventions: Drug: gemcitabine, vinorelbine, filgastrim; Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim

• Registration Number: NCT00163761
• Lead Sponsor: Bayside Health

Brief 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.

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-14
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Commence VGF treatment	gemcitabine, vinorelbine, filgastrim	Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
Commence F-GIV treatment	gemcitabine, vinorelbine, ifosfamide, filgastrim	Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To evaluate safety,	Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
relapse free survival,	After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
overall survival,	every 3 or 4 months for 12 months. Then every 6 months.
and planned dose-on-time.	After two cycles and after four cycles

Trial Locations

Locations (10)

Fremantle Hospital; 🇦🇺 Fremantle, Western Australia, Australia

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Mater Adult Hospital; 🇦🇺 South Brisbane, Queensland, Australia

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Frankston Hospital; 🇦🇺 Melbourne, Victoria, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Victoria, Australia

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Border Medical Oncology; 🇦🇺 Wodonga, Victoria, Australia