This trial is evaluating whether Luspatercept will improve 1 primary outcome and 5 secondary outcomes in patients with Myelodysplastic-Myeloproliferative Diseases. Measurement will happen over the course of Up to 8 weeks.
This trial requires 54 total participants across 2 different treatment groups
This trial involves 2 different treatments. Luspatercept is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"The MDS-MPD spectrum is a term applied to a set of clinically distinct disease entities characterized by similar cytogenetic and immunophenotypic abnormalities. The MDS/MPD spectrum comprises five diseases: MDS, with a preponderance of normal karyotypes, and MDS/AML, MDS-U, MDS/CML and MDS/TETRA, with ~60-70% of cases presenting with a normal karyotype. These five diseases have distinct cytogenetic, phenotypic, and clinical characteristics, and response to therapy." - Anonymous Online Contributor
"Results from a recent paper, the most common of the above signs were bone cysts, elevated C-reactive protein, enlarged liver, increased spleen size and/or hepatomegaly." - Anonymous Online Contributor
"Around 350,000 people have a diagnosis of myelodysplastic-myeloproliferative disease a year in the United States. myelodysplastic-myeloproliferative diseases are one of the most common types of heaematopoietic neoplasms.myelodysplastic-myeloproliferative diseases are a heterogeneous group of malignancies consisting of clonal myeloid and/or lymphoid precursor cell neoplasms whose cell of origin is a haematopoietic precursor cell." - Anonymous Online Contributor
"This case report suggests that in some MDS/MPN patients, i.e. patients with a low-risk profile and without BCR-ABL1 T315I mutation, the disease may be manageable and/or potentially eradicateable." - Anonymous Online Contributor
"Treatment of MDS depends on the particular disorder of patients. High doses of cytotoxic agents, e.g. cytosine arabinoside, can be used in order to overcome the lack of production of red blood cells. Other more specific types of therapy, e.g. aPHa and azacitidine, are used to prevent or prevent further deterioration of myeloproliferative disorders. The use of allogeneic stem cells is under ongoing research." - Anonymous Online Contributor
"Tumorigenesis is a significant contributor to the etiology of MDS and MMP, but the myeloproliferative component of these disorders is most likely to be caused by genetic factors of epigenetic origin." - Anonymous Online Contributor
"Based on the available data, there was only one case report of luspatercept use without other treatments, and many of the available case reports were for lupus patients undergoing chemotherapy. A large randomized clinical trial is currently planned with more specific enrollment and treatment objectives to establish these relationships." - Anonymous Online Contributor
"This report shows this condition often affects children under the age of 18. There were no differences in survival or cumulative risk by age. Findings from a recent study may suggest a need to target the treatment of older people at increased risk for the disease in order to decrease mortality and improve quality of life. A more accurate assessment of the natural history of myelodysplastic-myeloproliferative diseases in people older than 45 by the use of a prognosis calculator/model could provide useful guidance by allowing earlier detection and treatment of MDS-MCP." - Anonymous Online Contributor
"ClinicalTrials.gov does not provide information on any clinical trials using luspatercept. However, the FDA Safety Alert Database lists a study in which patients with MDS/PMF participated and this could provide additional clinical trials." - Anonymous Online Contributor
"Treatment of patients with lupercept led to a non-significant improvement in LTSS in one study, and there is no consensus in the literature on this. However, there are concerns in the literature that the effect of lupercept differs among patients of different disease risk. If this is reflected in the data from the lupercept studies, then we could think that lupercept will not affect LTSS. On the contrary, in this sense, a placebo is not helpful here either, because a patient has already received a treatment that is not effective." - Anonymous Online Contributor
"The prognosis of myelodysplastic-myeloproliferative diseases varies widely; therefore, the necessity for immediate treatment should be considered, especially for high-risk patients at the early stage of disease." - Anonymous Online Contributor
"Luspatercept is usually well tolerated, with the potential of substantial and sustained and clinically meaningful reductions in low levels of bone biomarkers with a normalizing or even restoring effect on haemopoiesis without increases in haemoglobin levels." - Anonymous Online Contributor