Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II pilot study evaluating the safety 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) in combination with Rituximab (R-VGF/R-F-GIV).

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

Details

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

Criteria

Inclusion Criteria:

• Age >18 years

• Relapsed or primary refractory CD20+ NHL

• 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