Active clinical trials for "Myelodysplastic Syndromes"

Study type An observational study conducted in different hematological centers in Belgium. Study objectives Primary objective: To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes. Secondary objectives: To assess the impact of newly started therapy on disease perception in MDS patients To study the relation between disease perception and quality of life To examine which clinical and disease specific factors determine QOL in MDS patients Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life. To evaluate whether changes in QOL are related to hematological respons. Study design Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy. QOL assessment with the QUALMS. Disease perception measurement using the B-IPQ. Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment. Study endpoints Primary endpoint: Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment. Secondary endpoint: Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment Association between B-IPQ and QUALMS score. Association between clinical and disease specific factors and QUALMS score Association between transfusion threshold and QUALMS score. Association between hematological response and QUALMS score Summary of eligibility criteria Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment. Signed informed consent. Patients enrolled in an unblinded interventional therapeutic trial are eligible. Exclusion criteria Patients with acute leukemia defined as >20% bone marrow blasts. Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease. Patients in post allogeneic transplant setting. Patients enrolled in a blinded interventional therapeutic trial. Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy. Newly diagnosed patients who do not start with treatment. Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed). Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion. Patients refusing to sign informed consent.

The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.

The present study is designed to determine the mutational status of markers (TET2 and PLCb2, cytogenetic aberrations) together with methylation status of the above genes using bone marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed for at least 2 years.

Study Objectives: To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the World Health Organization (WHO) criteria. To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples, and to present relevant research outcomes in the fields of diagnosis and prognostication, health related quality of life issues, health economics, and risk stratification for newly developed classes of drugs. To disseminate results of the studies to all stakeholders involved.