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Lenalidomide In Patients With Acute Myeloid Leukemia

2014-08-27 03:24:28 | BioPortfolio

Summary

This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide related serious adverse reactions encountered in the first cycle. For the purpose of this study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be determined and characterized.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia

Intervention

lenalidomide

Location

University Hospital of Bonn
Bonn
Germany
53111

Status

Recruiting

Source

University of Ulm

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:28-0400

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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.

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