The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment. The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
City of Hope National Medical Center
Duarte, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
The University of Iowa
Iowa City, Iowa, United States
New England Medical Center
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Physician's Global Assessment (PGA)
Time to Event Variables - Time to response, remission, treatment failure
Response based on the CD25 status
Response based on patient demographics: stage of disease, age, sex, performance status, total dose
Number of cycles completed
6. Assess safety and tolerability of ONTAK
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston, Massachusetts, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States