Status:
COMPLETED
Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma
Lead Sponsor:
Bayside Health
Conditions:
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the ti...
Detailed Description
Patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- age 18 to 70 years
- relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
- measurable disease (clinically or radiologically)
- ECOG 0 - 2
- written informed consent
- Exclusion criteria:
- 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
- isolated bone marrow disease
- known sensitivity to E coli derived preparations
Exclusion
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00163748
Start Date
February 1 2001
End Date
November 1 2003
Last Update
January 8 2016
Active Locations (2)
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1
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
2
The Alfred Hospital
Melbourne, Victoria, Australia, 3004