Efficacy Study of Outpatient Therapy for Lymphoma

Sponsor

Bayside Health (Other)

Overall Status

Completed

CT.gov ID

NCT00163761

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Hodgkin's Disease	Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim Drug: gemcitabine, vinorelbine, filgastrim	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Commence VGF treatment Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle	Drug: gemcitabine, vinorelbine, filgastrim Drug
Active Comparator: Commence F-GIV treatment Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle	Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim Drug

Arm

Intervention/Treatment

Active Comparator: Commence VGF treatment

Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle

Drug: gemcitabine, vinorelbine, filgastrim

Drug

Active Comparator: Commence F-GIV treatment

Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle

Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim

Drug

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Canberra Hospital	Canberra	Australian Capital Territory	Australia	2605
2	Royal North Shore Hospital	Sydney	New South Wales	Australia	2065
3	Mater Adult Hospital	South Brisbane	Queensland	Australia	4101
4	Royal Hobart Hospital	Hobart	Tasmania	Australia	7001
5	The Alfred Hospital	Melbourne	Victoria	Australia	3004
6	The Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
7	Frankston Hospital	Melbourne	Victoria	Australia	3199
8	Monash Medical Centre	Melbourne	Victoria	Australia	3199
9	Border Medical Oncology	Wodonga	Victoria	Australia	3690
10	Fremantle Hospital	Fremantle	Western Australia	Australia	6160