Lenalidomide In Patients With Acute Myeloid Leukemia
Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult
patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients
will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients
(to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3
patients) will be sequentially allotted to progressively higher dose levels of lenalidomide
on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide
related serious adverse reactions encountered in the first cycle. For the purpose of this
study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be
determined and characterized.