Status:
COMPLETED
Gemcitabine Hydrochloride, Cyclophosphamide, Vincristine Sulfate, Prednisolone, and Rituximab in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
Lead Sponsor:
University College, London
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
OBJECTIVES: * To determine whether rituximab, in combination with non-cardiotoxic chemotherapy comprising gemcitabine hydrochloride, cyclophosphamide, vincristine sulfate, and prednisolone, is effica...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL) according to the current WHO classification, including all morphological variants
- Newly diagnosed disease
- Bulky stage IA-IV disease
- No non-bulky stage IA disease
- Measurable disease
- Not eligible for CHOP chemotherapy due to impaired cardiac function
- Cardiac status that does not allow the administration of 8 courses of R-CHOP chemotherapy, as defined by 1 of the following criteria:
- Ejection fraction less than 50% as assessed by either ECHO or MUGA scan
- NYHA class III-IV
- No high-grade transformation of low-grade lymphoma
- No symptomatic central nervous system or meningeal involvement by the lymphoma
- No AIDS-related lymphoma
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Life expectancy \> 3 months
- Platelet count \> 100 x 10\^9/L
- WBC \> 3 x 10\^9/L
- Neutrophils \> 1.5 x 10\^9/L (unless elevated level attributed to bone marrow infiltration by lymphoma)
- Serum bilirubin \< 50 μmol/L
- Transaminases \< 2.5 times upper limit of normal (unless elevated level attributed to lymphoma)
- Glomerular filtration rate \> 30 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent uncontrolled medical condition
- No active malignant disease, other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix, within the past 10 years
- No positive serology for HIV
- No medical or psychiatric conditions that compromise the patient's ability to give informed consent
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or other investigational drug for this indication
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00971763
Start Date
March 1 2006
End Date
July 1 2011
Last Update
December 4 2014
Active Locations (4)
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1
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
2
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
3
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
4
Cancer Research UK and University College London Cancer Trials Centre
London, England, United Kingdom, SE1 9RT