Refractory TdT-Positive Leukemia Clinical Trial
Official title:
A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission.
In the first phase the Study Objectives are to:
- Define the maximally tolerated dose (MTD) and recommended dose (RD) for administration
of cordycepin as a 1-hour IV infusion, administered 1 hour following administration of
an IV bolus of pentostatin, in subjects with refractory TdT-positive leukemia;
- Determine plasma ADA levels prior to pentostatin infusion and at 60 and 120 minutes
after administration of pentostatin;
- Determine the single and multiple dose pharmacokinetics (PK) of cordycepin given 1 hour
after a fixed dose of pentostatin;
- Assess cordycepin pharmacodynamics by measurement of blast cell apoptosis from
peripheral blood smears;
- Measure and quantitate any clinical responses in refractory TdT-positive leukemia
patients following cordycepin/pentostatin administration.
In the second phase, the Study Objectives are to assess the safety, PK, and clinical
outcomes of cordycepin in combination with pentostatin, at the RD, in a 20 subject cohort
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment