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Completed

NCT Number: NCT00163761

Efficacy Study of Outpatient Therapy for Lymphoma

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemcitabine, vinorelbine, ifosfamide, filgastrim

Drug

Drug

gemcitabine, vinorelbine, filgastrim

Drug

Drug

Primary outcomes

  1. 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).

    Time frame: After two cycles and after four cycles

Secondary outcomes

  1. To evaluate safety,

    Time frame: Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.

  2. relapse free survival,

    Time frame: After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression

  3. overall survival,

    Time frame: every 3 or 4 months for 12 months. Then every 6 months.

  4. and planned dose-on-time.

    Time frame: After two cycles and after four cycles

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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