Efficacy Study of Outpatient Therapy for Lymphoma

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim
* Drug: gemcitabine, vinorelbine, filgastrim


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Commence VGF treatment<br>Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle | Drug: gemcitabine, vinorelbine, filgastrim<br>* Drug<br>|
| Active Comparator: Commence F-GIV treatment<br>Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle | Drug: gemcitabine, vinorelbine, ifosfamide, filgastrim<br>* Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma