Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia, Acute myelogenous leukemia (AML) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies. Subjects must have adequate organ and immune function as indicated by the following laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN Exclusion Criteria: Clinical evidence of active central nervous system (CNS) leukemic involvement Active and uncontrolled infection Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse. Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment. Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
Sites / Locations
- Cornell Medical College, New York Presbyterian
- MD Anderson