Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.
Condition or disease
Leukemia, Myeloid, Acute
Drug: Troxatyl™ (troxacitabine)
This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator’s discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
Subjects must have adequate organ and immune function as indicated by the following laboratory values:
Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2, and an estimated life expectancy of at least eight weeks.
Clinical evidence of active central nervous system (CNS) leukemic involvement
Active and uncontrolled infection
Uncontrolled medical problems unrelated to the malignancy that impair patient 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 Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
A recent history of alcohol or other substance abuse
Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
Females with a positive pregnancy test at screening
Subjects who have previously been enrolled into this study and subsequently withdrew