Efficacy Study of Outpatient Therapy for Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Hodgkin's Lymphoma Hodgkin's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Commence VGF treatment

Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle

Group Type ACTIVE_COMPARATOR

gemcitabine, vinorelbine, filgastrim

Intervention Type DRUG

Drug

Commence F-GIV treatment

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

Group Type ACTIVE_COMPARATOR

gemcitabine, vinorelbine, ifosfamide, filgastrim

Intervention Type DRUG

Drug

Interventions

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gemcitabine, vinorelbine, ifosfamide, filgastrim

Drug

Intervention Type DRUG

gemcitabine, vinorelbine, filgastrim

Drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No