Myelodysplastic Syndrome Clinical Trial
Official title:
A Phase I/II Optimal Dose Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS Patients
Revlimid® (Lenalidomide) is indicated for a type of blood cancer, myelodysplastic syndrome (MDS), at 10mg for a specific type of myelodysplastic syndrome with a genetic abnormality called "deletion 5q" in Low and Intermediate-1 (INT-1) patients (staging system according to International Prognostic Scoring System (IPSS)). The purpose of this Phase I/II study is to determine the optimal dose of Revlimid® (Lenalidomide) in MDS Low and MDS INT-1 patients without deletion 5q by slowly increasing the dose while monitoring blood counts for safety evaluation as well as observe other adverse events. Efficacy will also be observed for the phase II portion of the study.
There are little options for non deletion 5q Low and INT-1 patients. This study aims to find
an early clinical signal for higher activity and better response with lenalidomide in
patients with non deletion 5q Low and INT-1 MDS patients. Lenalidomide is an
immunomodulatory agent. Thalidomide, the parent compound, has both immunomodulatory and
anti-angiogenic properties which could confer anti-tumor and anti-metastatic efforts.
Lenalidomide has been demonstrated to possess anti-angiogenic activity through inhibition of
basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and tumor
necrosis factor-alpha (TNF-alpha) induced endothelial cell migration (movement of cells in
preparation to form new abnormal blood vessels for cancer cells), due at least in part to
inhibition of Akt phosphorylation response to bFGF.
In addition, lenalidomide has a variety of immunomodulatory effects. Lenalidomide stimulates
T cell proliferation, and the production of interleukin-2 (IL-2), IL-10 and interferon-gamma
(IFN-gamma), inhibits IL-1 beta and IL-6 and modulated IL-12 production.
Although the exact anti-tumor mechanism of action of lenalidomide is unknown, a number of
mechanisms are postulated for the activity of Lenalidomide in MDS.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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