[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644460":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":47,"collaborators":51,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Guangdong Second Provincial General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rotesip treatment group","EXPERIMENTAL","Patients were screened and enrolled in the treatment group to evaluate the efficacy and safety of rotezipeptide in the treatment of chemotherapy-inducing anemia in AML.",[13],"Drug: Luspatercept Injectable Product",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Luspatercept Injectable Product","First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg\u002Fkg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Guopan Yu, PhD","CONTACT","+8615876559968","yugpp@163.com",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},"Tianmiao Yu, Master","yutm96@163.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Department of Hematology, Guangdong Second Provincial General Hospital","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},[45,46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Qing Zhang","Chief Physician",[52,54,56,58,60,62],{"name":53,"class":6},"Nanfang Hospital, Southern Medical University",{"name":55,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":57,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":59,"class":6},"Guangzhou First People's Hospital",{"name":61,"class":6},"Affiliated Hospital of Guangdong Medical University",{"name":63,"class":6},"Guangzhou 8th People's Hospital","100644460","phase-1-luspatercept-for-cia-in-aml-100644460",false,"NCT07663864","Luspatercept for CIA in AML","Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study","Inclusion Criteria:\n\n1. De novo AML patients;\n2. Age ≥ 18 years and ≤ 60 years;\n3. AML with ELN2022-low risk\n4. Received 1-3 cycles of HDAC consolidation therapy\n5. HGB 60-90 G\u002FL\n6. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;\n7. Life expectancy ≥ 3 months;\n8. Signed informed consent and able to understand and comply with the procedures required by this protocol.\n\nExclusion Criteria:\n\n1. t-AML\u002FsAML\n2. Concurrent myelofibrosis\n3. Patients unresponsive to red blood cell transfusions\n4. Heart function \\\u003C grade 2\n5. Renal function: creatinine clearance \\\u003C 30 ml\u002Fmin\n6. Liver function: ALTd \\> 5 times normal, bilirubin \\> 3 times normal\n7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment\n8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization\n9. Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs\u002Fsymptoms that do not improve despite appropriate antibiotic, antiviral, and\u002For other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and\u002For hepatitis C. (HCV) infection\n10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients\n11. Pregnant or breastfeeding women\n12. Patients deemed unsuitable for enrollment by the investigators","ALL","18 Years","60 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.",[83],"Chemotherapy-inducing Anemia",[85,86,87,88],"Acute myeloid leukemia","Chemotherapy","Anemia","Luspatercept","2026-06-17",{"date":91,"type":92},"2026-06-23","ACTUAL",{"date":94,"type":76},"2026-06-01",{"date":96,"type":76},"2027-05-31",{"name":5,"class":6},1]