Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
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.
Drug: gemcitabine hydrochloride
Drug: vincristine sulfate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall response rate [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: End of treatment ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Not specified in protocol ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Up to 6 x 21 day cycles of R-GCVP:
|Biological: rituximab Drug: cyclophosphamide Drug: gemcitabine hydrochloride Drug: prednisolone Drug: vincristine sulfate|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971763
|Sussex Cancer Centre at Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BE|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leeds General Infirmary|
|Leeds, England, United Kingdom, LS1 3EX|
|Cancer Research UK and University College London Cancer Trials Centre|
|London, England, United Kingdom, SE1 9RT|
|Principal Investigator:||Paul Fields, MD||Cancer Research UK|