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Clinical Trial Summary

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.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Hodgkin's lymphoma.


Clinical Trial Description

OBJECTIVES:

- Determine the partial and complete response rates in patients with untreated or recurrent/refractory lymphocyte predominant Hodgkin's lymphoma treated with rituximab.

- Determine the efficacy of this regimen in terms of duration of disease free survival and time to progression in this patient population.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over several hours once a week for 4 weeks followed by maintenance rituximab at 6, 12, and 18 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 18 months. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00003820
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase Phase 2
Start date January 1999
Completion date August 2008

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