A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy
- To determine whether rituximab, in combination with non-cardiotoxic chemotherapy
comprising gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and
prednisolone, is efficacious in a group of patients who are unfit for CHOP
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8;
cyclophosphamide IV, vincristine sulfate IV, and rituximab IV on day 1; and oral
prednisolone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then every 6 months for 1 year.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Paul Fields, MD
Cancer Research UK