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Therapeutic Areas: Oncology | Hematology
Disease Category: Lymphomas

Trial Information

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma (RATE)

A Phase III Multicenter, Open-Label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma

This is a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with DLBCL and follicular NHL. Approximately 385 patients will be enrolled at approximately 100 centers in the United States in order to achieve at least 350 evaluable patients.

Inclusion Criteria:

• Written informed consent
• Age = 18 years
• Patients with previously untreated DLBCL who are scheduled to receive rituximab 375 mg/m^2 plus CHOP chemotherapy, or previously untreated follicular NHL who are scheduled to receive rituximab 375 mg/m^2 plus CVP chemotherapy

Exclusion Criteria:

• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Classification Grade II or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade II or greater peripheral vascular disease on Day 1

Patients who meet any of the following criteria will be excluded from further study participation after Cycle 1:

• Circulating lymphocyte count >5,000/µL before the Cycle 2 Rituximab infusion
• Development of a serious and/or Grade 3 or 4 adverse event during Cycle 1 judged by the investigator to be related to the rituximab infusion

Karen Eisenberg
Queens Medical Associates, PC
176-60 Union Turnpike 3, Suite 360
Fresh Meadows, NY 11366
Phone: 1 (718) 460-2300
Fax: 1 (718) 591-1706
EMail: keisenberg@queensmedical.com

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