Status:
COMPLETED
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Amgen
Conditions:
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and pred...
Detailed Description
Upon determination of eligibility, patients will receive: * Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab Patients that are not considered candidates for anthracycline thera...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma
- No previous treatment
- Clinical stage II, III, or IV by the Ann Arbor Staging Criteria
- Age \> 70 years
- ECOG performance status 0, 1, or 2
- Adequate bone marrow, liver and kidney function
- Must give written informed consent prior to entering this trial
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Age \< 18 years
- Central nervous system involvement with lymphoma
- Coexistent active malignancies treated within five years
- Active infection precluding the use of combination chemotherapy
- HIV infection
- Pregnant or lactating
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00193479
Start Date
April 1 2003
End Date
February 1 2010
Last Update
March 3 2022
Active Locations (2)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Tennessee Oncology
Nashville, Tennessee, United States, 37203