Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase I study with the goals of determining the feasibility, safety, and toxicity
of administering sertraline in combination with timed-sequential cytosine arabinoside (ara-C)
in adults with relapsed and refractory acute myeloid leukemia (AML).
Primary objective:
- To define the maximum tolerated dose (MTD) and Recommended Phase II Dose (RP2D) of
sertraline administered in combination with timed-sequential cytosine arabinoside in
adult patients with relapsed and refractory acute myeloid leukemia.
- To evaluate the safety and tolerability of sertraline given in combination with
timed-sequential cytosine arabinoside in adult patients with relapsed and refractory
acute myeloid leukemia.