The goal of this clinical research study is to find out if the study drug, ONTAK (denileukin diftitox), can shrink or slow the growth of B-cell non-Hodgkin's lymphoma (NHL) in patients whose disease has not responded to prior treatments, or has relapsed after an initial response to prior treatments. The safety of treatment with ONTAK will also be studied. The hypothesis is that patients with relapsed or refractory B-cell NHL and mild to moderate myelosuppression treated with ONTAK at a new dosing regimen will respond sufficiently to warrant further study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tower Cancer Research Foundation
Beverly Hills, California, United States
Pacific Coast Hematology/Oncology
Fountain Valley, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Disease Response will be evaluated by CT or MRI scans at baseline, every 8 weeks while on therapy, and every 3 months after therapy, using standard response criteria defined by Cheson et al.
Safety data will include laboratory, history and physical, and adverse events reports for both local and systemic signs or symptoms of study patients. Survival at one year post-therapy will also be assessed.
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Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
Washington University Siteman Cancer Center
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
...and 2 more locations