Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00031902|
Recruitment Status : Unknown
Verified February 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: bleomycin sulfate Biological: rituximab Drug: prednisolone Drug: vincristine sulfate||Phase 1|
- Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression and survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.
Patients are followed every 1-2 months.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma|
|Study Start Date :||October 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031902
|St. George's Hospital|
|London, England, United Kingdom, SW17 0QT|
|Chelsea Westminster Hospital|
|London, United Kingdom, SW10 9NH|
|Study Chair:||Ruth Pettengell, MD||St. George's Hospital|