Efficacy and Treatment Related Toxicity Study of a New Regimen for Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163748
• Other study ID #: AH152/00
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 6, 2016
• Start date: February 2001
• Est. completion date: November 2003

Study information

• Verified date: January 2016
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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 time of registration will have measurable relapsed or primary refractory lymphoma.

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 initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. The standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. However, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• gemcitabine, vinorelbine

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal North Shore Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy and regimen related toxicity of the study treatment (vinorelbine and gemcitabine with filgrastim support).
Secondary	To evaluate the requirement for inpatient admission and / or parenteral antibiotic therapy following study treatment in an outpatient setting.