[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndromes-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndromes-adult":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100569334","defining-inflammatory-markers-of-cardiovascular-disease-in-patients-with-myelodysplastic-syndromes-100569334",false,"NCT06692894","Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes","Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤3\n* Expected survival of at least 6 months\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis\n* Hematopoietic stem cell transplantation expected within 6 months","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","OBSERVATIONAL","Why Is This Research Study Being Conducted?\n\n* The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.\n* Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.\n* By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS",[24],"Myelodysplastic Syndromes, Adult",[26,27],"Myelodysplastic Syndromes","Hematology","RECRUITING","2026-02-02",{"date":31,"type":32},"2026-02-03","ACTUAL",{"date":34,"type":32},"2024-11-05",{"date":36,"type":20},"2027-11",{"name":38,"class":39},"University of Vermont","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100531419","phase-1-a-study-to-investigate-treatment-of-hu-and-vpa-or-6-mp-and-vpa-in-unfit-amlhr-mds-patients-100531419","NCT06199557","A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML\u002FHR-MDS Patients","A Phase 1\u002F2 Multicenter Open-label Study to Investigate Treatment of Hydroxyurea in Combination With Valproic Acid (VPA), or 6- Mercaptopurine in Combination With VPA in Patients With AML or HR-MDS Unfit for Standard Therapy","HUVAMER","Inclusion Criteria:\n\nParticipants are eligible for the study only if all of the following criteria apply:\n\no Female or male, age 18 years or older\n\n* Written informed consent\n* Patients with Newly diagnosed AML, as defined by ELN 2022 criteria, or relapsed\u002Frefractory AML who: - are unfit, defined as HCT-CI ≥ 3, or - in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n\n  * the patient has declined standard therapy\n\nNewly diagnosed HR-MDS, or relapsed\u002Frefractory HR-MDS who:\n\n* are unfit, defined as HCT-CI ≥ 3, or\n* in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n* has declined standard therapy\n\nSecondary AML (MDS-related\u002F therapy- induced), or\n\nAcute promyelocytic leukemia not eligible for standard therapy and\u002For specific therapy.\n\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Serum creatinine ≤1.5 x ULN;\n  * Estimated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation);\n  * Hepatic function;\n\n    i. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); ii. Aspartate aminotransferase (AST)\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iii. Alanine aminotransferase (ALT)\n\n    \u003C!-- -->\n\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iv. Alkaline phosphatase (ALP)\n\n    1\\. ≤2.5 × ULN\n* European Cooperative Oncology Group (ECOG) performance status 0, 1, 2 or 3\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of study medication. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for \\>3 months after the last dose of study medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:\n\n  1. Natural menopause with last menses \\>1 year ago\n  2. Radiation induced oophorectomy with last menses \\>1 year ago\n  3. Chemotherapy induced menopause with last menses \\>1 year ago\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Patients on treatment for AML (any anti-leukemic therapy including investigational agents) or treated less than 2 weeks before inclusion.\n* Concurrent history of active malignancy in the past six months prior to diagnosis except for\n\n  * basal and squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease et cetera) at the investigators discretion.\n* Breastfeeding women\n* Cardiac dysfunction as defined by:\n\n  * myocardial infarction within the last 3 months of study entry, or\n  * congestive heart failure NYHA class IV or\n  * unstable angina, or\n  * unstable cardiac arrhythmias\n* SARS-CoV-2 infection \\\u003C 7 days or Covid-19-vaccine \\\u003C 7 days from study onset\n* Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.\n* Patients with any serious concomitant medical condition that could, in the opinion of the investigator, compromise participation in the study.\n* Patients with senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.\n* Known hypersensitivity to study medications or its excipients.\n* Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":50,"type":20},48,"INTERVENTIONAL",[53,54],"PHASE1","PHASE2","The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome.\n\nThe population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit\u002Fineligible for standard treatment, and relapsed\u002Frefractory AML\u002FHR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.",[57,24],"Acute Myeloid Leukemia, Adult","2025-06-25",{"date":60,"type":32},"2025-06-29",{"date":62,"type":32},"2024-05-23",{"date":64,"type":20},"2029-09-30",{"name":66,"class":39},"Haukeland University Hospital",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100563190","phase-2-prophylactic-intervention-for-relapse-prevention-post-allogeneic-transplantation-in-very-high-risk-mds-patients-based-on-ipss-m-stratification-100563190","NCT06612944","Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification","Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification: A Single-Arm, Prospective, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years, inclusive, both male and female. Diagnosed with MDS according to WHO criteria and classified as very high-risk by IPSS-M scoring. The patient must have a suitable hematopoietic stem cell donor for allogeneic transplantation: Related donors must be at least 5\u002F10 matched for HLA-A, -B, -C, -DQB1, and -DRB1\n2. Unrelated donors must be at least 8\u002F10 matched for HLA-A, -B, -C, -DQB1, and -DRB1. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of ≤ 2. ECOG performance status of 0-2. Adequate liver, kidney, cardiac, and pulmonary functions as follows: Serum creatinine ≤ 1.5× upper limit of normal (ULN)\n3. Cardiac function: Ejection fraction ≥ 50%\n4. Baseline oxygen saturation \\> 92%\n5. Total bilirubin ≤ 1.5× ULN\n6. ALT and AST ≤ 2.0× ULN\n7. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 ≥ 50%. Patients must be capable of understanding and willing to participate in the study, and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning. History of previous hematopoietic stem cell transplantation (HSCT). ECOG performance status \\> 2. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3. Any unstable systemic disease including, but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within the past 3 months, myocardial infarction within the past 3 months, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), post-pacemaker implantation requiring medication for severe arrhythmias, severe liver, kidney, or metabolic diseases\n2. patients with pulmonary arterial hypertension. Active, uncontrolled infection: hemodynamic instability related to infection, new symptoms or signs of worsening infection, radiological evidence of new infectious foci, persistent fever without signs or symptoms that cannot exclude infection. Need for treatment for Grade ≥2 epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson\\'s disease, schizophrenia. HIV infection. Active hepatitis B (HBV) or hepatitis C (HCV) requiring antiviral treatment\n3. patients at risk of HBV reactivation, indicated by positive hepatitis B surface antigen or core antibody without antiviral therapy for hepatitis B. Pregnant or breastfeeding women. Men and women of childbearing potential unwilling to use contraception during the treatment and for 12 months post-treatment. Allergic to intervention drugs such as azacitidine, decitabine, or venetoclax.","70 Years",{"count":76,"type":20},40,[54],"By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells \\> 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.",[24],"2024-11-19",{"date":82,"type":32},"2024-11-26",{"date":84,"type":32},"2024-11-12",{"date":86,"type":20},"2028-11-12",{"name":88,"class":39},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine"]