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Efficacy Study of Outpatient Therapy for Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Investigator initiated study
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163761
First received: September 11, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Drug: gemcitabine, vinorelbine, ifosfamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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).

Secondary Outcome Measures:
  • To evaluate safety,
  • relapse free survival,
  • overall survival,
  • and planned dose-on-time.

Estimated Enrollment: 90
Study Start Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163761

Locations
Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Queensland
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Australia, Victoria
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Monash Medical Centre
Melbourne, Victoria, Australia, 3199
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Sponsors and Collaborators
Bayside Health
Investigator initiated study
Investigators
Study Chair: Andrew Spencer, Assoc. Prof
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163761     History of Changes
Other Study ID Numbers: AH226/02
Study First Received: September 11, 2005
Last Updated: September 11, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 23, 2014