Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma

Status Completed

Clinical Trial Summary

This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of Rituximab (which is a form of immunotherapy).

Clinical Trial Description

Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients relapse, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Multiple studies have shown the value of high-dose chemotherapy, with increased disease-free survival and overall survival, when compared with second-line conventional chemotherapy. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it, and other treatment strategies are needed to improve the cure rate.

Another treatment option called immunotherapy is being tested in lymphoma patients. Immunotherapy involves attempts to use the immune system or products of the immune system to fight lymphoma. For example, NHL cells have a protein called CD20 on their surface. Rituximab is an antibody directed against the CD20 protein, which may result in the death of the lymphoma cell. Patients in this study will receive Rituximab to see if it is a safe treatment option for NHL patients. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00143871
Study type	Interventional
Source	University of Michigan Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	April 2001
Completion date	January 2007

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See also
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