The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
University of Chicago Medical Center
Chicago, Illinois, United States
Louisana State University Health Sciences Center
Shreveport, Louisiana, United States
New York Medical College Division of Oncology
Valhalla, New York, United States
Liberty Hematology and Oncology
Columbia, South Carolina, United States
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
To determine the rate of CR achieved based on prior HSCT status
Assess safety and tolerability
Assess survival end points
Evaluate the maintenance and duration of response
Evaluate the proportion of patients able to proceed to HSCT
Evaluate the effects of this forodesine regimen on plasma levels of dGuo
Determine the effects of this forodesine regimen on clinical end points
Explore potential predictive biomarkers
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States