[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641405":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":63,"overallOfficials":43,"centralContacts":72,"locations":43,"responsibleParty":78,"collaborators":43,"id":82,"slug":43,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":43,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":43,"enrollmentInfo":90,"targetDuration":43,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":43,"overallStatus":99,"whyStopped":43,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":43},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"HI-P","hematological response - platelet","1-month, 2-month, 3-month, 6-month",{"measure":14,"description":15,"timeFrame":12},"ORR","ORR=CRR+PRR+HI",[17,21,24,28,32,36,40],{"measure":18,"description":19,"timeFrame":20},"Number of bleeding incidents and severity assessed by the World Health Organization Bleeding Scale","minimum value = 0, maximum value = 4; higher scores indicate worse outcome","3-month, 6-month",{"measure":22,"description":23,"timeFrame":20},"Platelet transfusion independence","according to the number and interval of platelet transfusions",{"measure":25,"description":26,"timeFrame":27},"Time to CR\u002FOR","Time from baseline to first response","through study period, an average of 6 months",{"measure":29,"description":30,"timeFrame":31},"Duration of HI-P","Time to patients achieving HI-P to losing response","through study period, an average of 6-month",{"measure":33,"description":34,"timeFrame":35},"Quality of life score measured by the Short Form-36 Health Survey","minimum value = 0, maximum value = 100; higher scores indicate better quality of life","3-month",{"measure":37,"description":38,"timeFrame":39},"Clonal evolution","The incidence of elevation of blast cells in bone marrow and peripheral blood within one year, and the incidence of progressing to higher-risk MDS or AML within one year","12-month",{"measure":41,"description":42,"timeFrame":39},"OS","Overall survival (OS), defined as the time from randomization\u002Ftreatment start to death from any cause.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"rhTPO+CsA","EXPERIMENTAL","rhTPO 300U\u002Fkg\u002Fd, CsA 3-5mg\u002Fkg\u002Fd",[56,57],"Drug: rhTPO","Drug: Cyclosporine (CsA)",{"label":59,"type":60,"description":61,"interventionNames":62},"CsA","ACTIVE_COMPARATOR","CsA 3-5mg\u002Fkg\u002Fd",[57],[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":43},"DRUG","rhTPO","rhTPO 300U\u002Fkg\u002Fd, subcutaneous injection, once a month for 14 consecutive days",[52],{"type":65,"name":70,"description":61,"armGroupLabels":71,"otherNames":43},"Cyclosporine (CsA)",[59,52],[73],{"name":74,"role":75,"phone":76,"phoneExt":43,"email":77},"Bing Han, Doctor","CONTACT","+86 13601059938","hanbing_li@sina.com.cn",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Bing Han","Professor","100641405",false,"NCT07653581","rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thrombocytopenia","rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Confirmed diagnosis of lower-risk MDS;\n3. Platelet ≤ 30×109\u002FL, or \\\u003C 50×109\u002FL and accompanied by bleeding events;\n4. Baseline liver and kidney functions \\\u003C2 ULN;\n5. Signed the informed consent form;\n6. ECOG 0-2;\n\nExclusion Criteria:\n\n1. History of leukemia or stem cell transplantation, treatment-related MDS or malignant tumors;\n2. With splenomegaly or myelofibrosis;\n3. Infections or bleeding that cannot be controlled by standard treatment;\n4. Any concurrent malignant tumors within the past 5 years, or basal cell carcinoma of the skin at the local site;\n5. History of thromboembolic events, heart attack or stroke and current use of anticoagulants;\n6. Previously received cyclosporine (CsA) or ATG within 6 months;\n7. Previously used IL-11, rhTPO or TPO-RA;\n8. Pregnant or lactating women;\n9. Participated in other clinical trials within 3 months.","ALL","18 Years",{"count":91,"type":92},78,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.",[98],"Lower-risk Myelodysplastic Syndromes","NOT_YET_RECRUITING","2026-06-11",{"date":102,"type":103},"2026-06-17","ACTUAL",{"date":105,"type":92},"2026-06",{"date":107,"type":92},"2029-12",{"name":5,"class":6}]