A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes
Myelodysplastic syndrome (MDS) is a group of different kinds of stem cell abnormalities. It
is characterized by low blood counts and abnormal blood cell formation. These abnormal blood
cells can cause fatigue, shortness of breath, infection, and bleeding. There is significant
risk of developing acute leukemia in this disorder.
The only known curative therapy is an allogeneic bone marrow transplant of which the vast
majority of patients with this disorder are not candidates. Currently three drugs have been
approved for the treatment of MDS: azacytidine, decitabine and lenalidomide for low grade
patients with a chromosome 5q abnormality. Azacytidine and decitabine have been
demonstrated to improve blood counts, improve the quality of life, and decrease the risk of
progression to AML or death in a sizable minority of MDS patients. A recent study of MDS
patients who had responded clinically to decitabine revealed that their bone marrow biopsies
still showed stromal abnormalities such as increased angiogenesis. Lenalidomide acts at the
level of the stromal - marrow cell interaction. It is hypothesized that the combination of
decitabine with lenalidomide may show synergistic results.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose (MTD)as defined by the protocol
Cycle 1
Yes
Carlos de Castro, MD
Principal Investigator
Duke University
United States: Institutional Review Board
Pro00010179
NCT00828802
March 2009
August 2014
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |