Lymphoma Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cyclophosphamide,
vincristine sulfate, and prednisolone, work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
such as rituximab, can block cancer growth in different ways. Some block the ability of
cancer cells to grow and spread. Others find cancer cells and help kill them or carry
cancer-killing substances to them. Giving more than one drug (combination chemotherapy)
together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying giving gemcitabine hydrochloride, cyclophosphamide,
vincristine sulfate, and prednisolone together with rituximab to see how well it works in
treating patients with newly diagnosed diffuse large B-cell lymphoma.
OBJECTIVES:
- 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
chemotherapy.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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