Efficacy Study of Outpatient Therapy for Lymphoma

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Bayside Health
• Treatments: Gemcitabine; Ifosfamide; Isophosphamide mustard; Vinblastine; Vinorelbine

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