Advertisement

Topics

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After treatment is ended or a patient is withdrawn from the study, all patients will be followed for safety, relapse and survival.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

Clinical Trials [2477 Associated Clinical Trials listed on BioPortfolio]

A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first cour...

Trial of Decitabine in Patients With Acute Myeloid Leukemia

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient...

CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less ...

Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

This research trial studies metabolic changes in blood samples from patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laborat...

Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid Leukemia (AM...

PubMed Articles [8632 Associated PubMed Articles listed on BioPortfolio]

Acute external otitis as debut of acute myeloid leukemia - A case and review of the literature.

Acute leukemia is a well known childhood cancer. The relation between leukemia and otological symptoms has long been established but is highly rare as a debut symptom of leukemia. External otitis is a...

The importance of meaningful activity in people living with acute myeloid leukemia.

The symptom burden of acute myeloid leukemia (AML) and its treatment can accelerate physical deconditioning and impair mobility and quality of life. In the present study, we explore the subjective exp...

Widespread use of measurable residual disease in acute myeloid leukemia practice.

Measurable residual disease (MRD) has prognostic importance for patients with acute myeloid leukemia (AML). How leukemia providers incorporate MRD into routine practice remains undefined.

Controversies Regarding Use of Myeloid Growth Factors in Leukemia.

This review focuses on the data supporting the use of myeloid growth factors (MGFs) in patients being treated for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, and ha...

Development and Validation of a Novel RNA Sequencing-Based Prognostic Score for Acute Myeloid Leukemia.

Recent progress in sequencing technologies allows us to explore comprehensive genomic and transcriptomic information to improve the current European LeukemiaNet (ELN) system of acute myeloid leukemia ...

Medical and Biotech [MESH] Definitions

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.

More From BioPortfolio on "Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Leukemia
Leukemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases. In turn, it is part of the even broader grou...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial