Efficacy Study of Outpatient Therapy for Lymphoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163761

Enrollment

Registered

2005-09-14

Start date

2002-12-31

Completion date

2008-02-29

Last updated

2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Disease, Non-Hodgkin's Lymphoma

Keywords

Lymphoma

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.

Interventions

DRUGgemcitabine, vinorelbine, ifosfamide, filgastrim

Drug

DRUGgemcitabine, vinorelbine, filgastrim

Drug

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026