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Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)

2014-08-27 03:12:47 | BioPortfolio

Summary

The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with late stage acute myeloid leukemia (AML).

Description

This is a study that investigates a new drug, elacytarabine, in late stage 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. For late stage AML, no standard therapy exists.

Elacytarabine is an investigational drug which is not commercially available. It consists of a fatty acid that is connected to a drug called cytarabine. Cytarabine is routinely used in the initial treatment of patients with AML. A substantial portion of AML patients do, however, have a deficient uptake of cytarabine in their leukemic cells due to a lack of a transport protein (called hENT1) in the cell membrane. Due to the connection to the fatty acid, cellular uptake of elacytarabine is independent of this transport protein, which offers a potential advantage for elacytarabine in the treatment of AML.

Patients included in the study will be randomized to elacytarabine or control treatment, defined as Investigator's choice. This is a selection of treatments used to treat late stage AML. The investigator will decide which treatment is most suitable for each patient.

Elacytarabine is given as a continuous infusion over five days, followed by a rest period of minimum two weeks.

After each course response evaluation and a decision about further treatment will be made.

Repeated courses of elacytarabine and control treatment might be needed to attain and/or maintain complete remission.

After treatment is ended or a patient is withdrawn from the study, all patients will be followed for safety, relapse and survival.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia (AML)

Intervention

Elacytarabine, Investigator's Choice

Location

St. Francis Hospital and Health Center
Indianapolis
Indiana
United States
46107

Status

Recruiting

Source

Clavis Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:47-0400

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