This trial is evaluating whether Azacitidine will improve 2 primary outcomes and 7 secondary outcomes in patients with Myelodysplastic Syndromes (MDS). Measurement will happen over the course of Number of days from the date of treatment initiation to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first, assessed up to 5 years.
This trial requires 32 total participants across 1 different treatment group
This trial involves a single treatment. Azacitidine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
"Myelodysplastic syndromes occur due to abnormalities in the maturation of precursor cells. These abnormalities are thought to arise from a common genetic lesion or to be acquired as a result of environmental exposures or inherited genetic disease. Although the causes of AMPS and AML are not well defined, genes and environmental risk factors are being discussed. We propose to use the term AMPS/AML as a diagnosis for the genetic lesion(s) involved in the pathogenesis of myelodysplastic syndrome and, presumably, leukemia in a large proportion of patients." - Anonymous Online Contributor
"In a series of patients with a wide range of clinical and laboratory features, long-term progression-free survival was reported. The study was retrospective and not controlled in terms of the efficacy of the treatment, which was given on the basis of the degree of cytolysis only. However, the results of the treatment are promising and lead to a reevaluation of the strategy of these patients." - Anonymous Online Contributor
"Many MDSs can be cured with intensive and often complicated protocols of treatment. This is possible in the case of some MDSs with an appropriate cytogenetic abnormality, in which the chromosomal abnormalities themselves can be treated successfully as other chromosome changes. In most cases, MDSs must be treated with supportive care alone. Although more chemotherapeutic agents have been explored, most of them require at least 2 cycles of induction chemotherapy unless the person is not fit for autologous stem-cell transplantation (ASCT) or does not respond to the initial drug. MDSs of low grade that do respond to induction chemotherapy can often be cured with supportive treatment alone." - Anonymous Online Contributor
"It has been shown that, in general, patients with MDS have a poorer prognosis than those without MDS. However, MDS is a heterogeneous entity and more than one sign or symptom could be present. The MDS specific presentation, including cytogenetic abnormalities, marrow morphology, immunophenotype, and presence of the V617F mutation are the principal signs of MDS. In contrast to primary myeloma, bone marrow aspirates are usually normal, thus the presence of a plasma cell dyscrasia should be considered." - Anonymous Online Contributor
"MDS manifests as a multitude of different phenotypes which are distinguished from other hematologic malignancies by clinical, bone marrow dysplasia, immunophenotypical, and chromosomal abnormalities. The MDS phenotypic spectrum involves a heterogeneous population with the most severe disease being sub-clinical." - Anonymous Online Contributor
"Only 60 people per year get MDS. Myeloproliferative disease is much more common than myelodysplastic disease in the United States, which suggests it must have some other explanation. While some studies have found this to be of African heritage, recent studies have not. Thus, the apparent increased risk associated with African ancestry may be due to better cancer screening in African American populations, or may be due to differences in socioeconomic status." - Anonymous Online Contributor
"Many patients with MDS get progressively less white blood cells and progressively less platelets. This deterioration can lead to a transfusion requirement or even platelet transfusion. The time it takes for this deterioration to occur varies considerably between patients. There is no doubt that a clinical trial tailored to a particular patient can improve outcomes by speeding up the process for each patient. [Power - find clinical trials tailored to your condition (MYELODYSPLASTICSYNDROMES) if you want to get your blood count back up to normal." - Anonymous Online Contributor
"The latest developments are limited to a more frequent dosing regimen based on the efficacy and safety of this agent in this setting, coupled with the potential improvement in safety and tolerability. The clinical use of azacitidine remains contraindicated in patients with myelodysplastic syndromes, in patients with a WBC count above 20 x 10(9)/L at the time of diagnosis and in patients who develop a hypersensitivity reaction during the administration of an autologous peripheral blood stem cell transplant." - Anonymous Online Contributor
"Overall survival was comparable to other chemotherapy regimens for myelodysplastic syndromes. We found that azacitidine had no increased toxicity, shorter durations of treatment, and reduced number of required hospitalization. Azacitidine was well tolerated in patients with low baseline hemoglobin. Data from a recent study support its use for patients with myelodysplasia." - Anonymous Online Contributor
"Azacitidine is well tolerated and well tolerated in people with MD in addition to other cytopenias. It is therefore unlikely that it will cause any complications for patients with MD. We therefore recommend that azacitidine is prescribed for patients with MD." - Anonymous Online Contributor
"Age [is not] a reliable factor that predicts the patient's prognosis [because] there are patient's with MDS of all ages, and the risk of death of MDS depends on the patient's genetic predisposition. A close surveillance of MDS is recommended, and patients with MDS will eventually need a hematopoietic stem cell transplantation to [improves their prognosis] and is an effective and safe procedure (http://www.withpower.com/health/haematopoietic_stem-cell_transplantations)." - Anonymous Online Contributor
"Many MDS patients do require treatment in their lifetime and are willing to participate in clinical trials. Therefore, patients with MDS should be considered even when their disease is localized." - Anonymous Online Contributor