Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00971763
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-GCVP rituximab Up to 6 x 21 day cycles of R-GCVP: * Gemcitabine 750mg/m\^2 days 1 \& 8 (increasing to 875mg/m\^2 for cycle 2 \& 1g/m\^2 for subsequent cycles if tolerated satisfactorily) * Cyclophosphamide 750mg/m\^2 day 1 * Vincristine 1.4mg/m\^2 day 1 (capped at 2mg) * Prednisolone 100mg/day days 1-5 * Rituximab 375mg/m\^2 day 1 * Neulasta 6mg day 9 R-GCVP cyclophosphamide Up to 6 x 21 day cycles of R-GCVP: * Gemcitabine 750mg/m\^2 days 1 \& 8 (increasing to 875mg/m\^2 for cycle 2 \& 1g/m\^2 for subsequent cycles if tolerated satisfactorily) * Cyclophosphamide 750mg/m\^2 day 1 * Vincristine 1.4mg/m\^2 day 1 (capped at 2mg) * Prednisolone 100mg/day days 1-5 * Rituximab 375mg/m\^2 day 1 * Neulasta 6mg day 9 R-GCVP gemcitabine hydrochloride Up to 6 x 21 day cycles of R-GCVP: * Gemcitabine 750mg/m\^2 days 1 \& 8 (increasing to 875mg/m\^2 for cycle 2 \& 1g/m\^2 for subsequent cycles if tolerated satisfactorily) * Cyclophosphamide 750mg/m\^2 day 1 * Vincristine 1.4mg/m\^2 day 1 (capped at 2mg) * Prednisolone 100mg/day days 1-5 * Rituximab 375mg/m\^2 day 1 * Neulasta 6mg day 9 R-GCVP vincristine sulfate Up to 6 x 21 day cycles of R-GCVP: * Gemcitabine 750mg/m\^2 days 1 \& 8 (increasing to 875mg/m\^2 for cycle 2 \& 1g/m\^2 for subsequent cycles if tolerated satisfactorily) * Cyclophosphamide 750mg/m\^2 day 1 * Vincristine 1.4mg/m\^2 day 1 (capped at 2mg) * Prednisolone 100mg/day days 1-5 * Rituximab 375mg/m\^2 day 1 * Neulasta 6mg day 9 R-GCVP prednisolone Up to 6 x 21 day cycles of R-GCVP: * Gemcitabine 750mg/m\^2 days 1 \& 8 (increasing to 875mg/m\^2 for cycle 2 \& 1g/m\^2 for subsequent cycles if tolerated satisfactorily) * Cyclophosphamide 750mg/m\^2 day 1 * Vincristine 1.4mg/m\^2 day 1 (capped at 2mg) * Prednisolone 100mg/day days 1-5 * Rituximab 375mg/m\^2 day 1 * Neulasta 6mg day 9
- Primary Outcome Measures
Name Time Method Overall response rate End of treatment
- Secondary Outcome Measures
Name Time Method Toxicity End of treatment Progression-free survival Not specified in protocol Overall survival Not specified in protocol
Trial Locations
- Locations (4)
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
Cancer Research UK and University College London Cancer Trials Centre
🇬🇧London, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom