A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin's Lymphoma (RATE) - NCT00719472-06824 (Clinical Trial 232158)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy232158.aspx
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| City: |
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Fairfield |
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State:
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CT |
| Zip Code: |
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06824 |
| Conditions: |
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Non-Hodgkin's Lymphoma |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Medical Specialists of Fairfie
Fairfield, CT 06824
United States
Primary Contact:
Gayle Mirto
Email: ngmirt@bpthosp.org
Phone: 203-255-4545
Secondary Contact:
Mark Fisher
Email: fisher.mark-OPER@gene.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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