Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia
The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).
The study investigates the new nucleoside analogue derivative, elacytarabine, as treatment
for patients with relapsed or refractory Acute Myeloid Leukemia (AML). To be included in the
study, patients must have failed to respond to two or three different therapies for AML, or
have obtained remission but then relapsed within a relatively short period of time. Patients
of age ≥ 65 with adverse cytogenetics can be included in the study after having received one
and up to three previous induction/re-induction therapies.
Elacytarabine is an investigational drug which is not commercially available. It is the
elaidic acid ester derivative of cytarabine. Cytarabine is routinely used in the treatment
of patients with AML. A substantial portion of AML patients have a deficient uptake of
cytarabine, often explained by lack of a transport protein (hENT1) in the leukemic cell
membrane. Due to the elaidic acid (a naturally occurring fatty acid), cellular uptake of
elacytarabine is independent of this transport protein.
Patients included in the study will be randomized to elacytarabine or control treatment.
Since there is no standard therapy for relapsed or refractory AML, there is a list of 7
control treatments and the investigator has to choose one that is locked before
randomization.
Elacytarabine is given as a continuous infusion over five days, followed by a rest period of
minimum two weeks. Investigator's choice treatment is given according to the specific
routine.
After each course response evaluation and a decision on further treatment will be made.
Repeated courses of elacytarabine and control treatment might be needed to attain and/or
maintain complete remission or clinical benefit.
After the end of study treatment, all patients will be followed for relapse and survival.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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