The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Central Baptist Hospital
Lexington, Kentucky, United States
Hematology and Oncology Services
Metairie, Louisiana, United States
Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.
Complete response: achievement of a complete regression for \>4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for \>4 weeks and had indeterminate bone marrow biopsy
Time frame: 24 Weeks
Duration of Response
The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.
Time frame: From beginning of response to time of relapse
Time-to-Treatment Failure
Time frame: From start of first treatment
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