Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies
Despite the great strides that have been made in improving the outcome with frontline
programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the
prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a
purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.
The purpose of the phase I portion of the study is to determine the maximum tolerated dose
(MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.
The purpose of the phase II portion of the study is to determine the safety and efficacy of
BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an
additional course of treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Deborah A. Thomas, M.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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