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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Treatments: Gemcitabine; Vinorelbine

Criteria

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