Myelodysplastic Syndrome Clinical Trial
Official title:
The Experimental Treatment of Transfusion Dependent 5q Minus Syndrome With Leucovorin
The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5
in the normal genetic make-up of the cells responsible for forming blood cells. The
condition causes patients to have the inability to make blood normally. Many patients with
this syndrome need transfusions of red blood cells, platelets, and/or white blood cells. Low
levels of platelets may cause the patient to bleed easily and low levels of whit blood cells
make the patient susceptible to infections. A small number of patients with 5 q minus
syndrome develop leukemia, which is often untreatable with chemotherapy.
Researchers believe that one of the genes missing in 5 q minus syndrome is the gene
responsible for making folic acid active in the body. Folic acid is a vitamin required for
normal blood production.
The purpose of this study to test the effectiveness of a drug called leucovorin for the
treatment of 5 q minus syndrome. Leucovorin is an active form of the vitamin folic acid that
does not require the missing genes to activate it.
Patients participating in this study may or may not improve with leucovorin treatment.
However, the study will improve researchers understanding of the disease and may lead other
potential therapies for the disease.
The objective of this protocol is to determine whether leucovorin treatment can normalize hematopoietic cell growth and differentiation in patients with 5q- syndrome which may lack the gene for dihydrofolate reductase enzyme. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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