[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625522":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":83,"collaborators":87,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Morning G-CSF Dosing","ACTIVE_COMPARATOR","10 μg\u002Fkg subcutaneous once daily for 5 days at 08:00 ± 15 min",[13],"Drug: G-CSF (Granulocyte colony-stimulating factor)",{"label":15,"type":16,"description":17,"interventionNames":18},"Evening G-CSF Dosing","EXPERIMENTAL","10 μg\u002Fkg subcutaneous once daily for 5 days at 20:00 ± 15 min",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","G-CSF (Granulocyte colony-stimulating factor)","Subcutaneous recombinant human G-CSF (10 μg\u002Fkg once daily) administered for 5 consecutive days. Participants are assigned to a fixed dosing time: 08:00 (±15 minutes) or 20:00 (±15 minutes). Peripheral blood CD34+ is measured approximately 12 (±1) hours after the last dose and within 60 minutes before the first apheresis. The first apheresis begins \\~12 (±1) hours after the final G-CSF dose. A second collection day may be performed per standard practice if the first-day yield does not meet the target; rescue mobilization (e.g., plerixafor) may be used per center practice when pre-defined low CD34+ criteria are met and will be recorded.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Hengwei Wu, MD","CONTACT","+8619858162455","cctv3194495@163.com",[33,51,66],{"facility":34,"status":35,"city":36,"state":37,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The First Affiliated Hospital of Zhengzhou University","RECRUITING","Zhengzhou","Henan","China","CN",{"type":41,"coordinates":42},"Point",[43,44],113.64861,34.75778,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":25,"email":50},"Weijie Cao, MD","+86 0371-66278897","caoweijie2003@126.com",{"facility":52,"status":35,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030",{"type":41,"coordinates":57},[58,59],114.26667,30.58333,{"lat":59,"lon":58},[62],{"name":63,"role":29,"phone":64,"phoneExt":25,"email":65},"Wei Shi, MD","+86 027-83663337","shiwei076@hust.edu.cn",{"facility":67,"status":35,"city":68,"state":69,"zip":70,"country":38,"countryCode":39,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The First Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","310000",{"type":41,"coordinates":72},[73,74],120.16142,30.29365,{"lat":74,"lon":73},[77,80],{"name":28,"role":29,"phone":78,"phoneExt":25,"email":79},"19858162455","wuhengwei@zju.edu.cn",{"name":81,"role":29,"phone":82,"phoneExt":25,"email":25},"Yanmin Zhao, MD","057187236706",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Yanmin Zhao","professor",[88,89,91,93],{"name":34,"class":6},{"name":90,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":92,"class":6},"Tongji Hospital",{"name":94,"class":6},"Ruijin Hospital","100625522","chrono-mobilize-chronotherapy-of-g-csf-for-cd34-mobilization-in-healthy-donors-100625522",false,"NCT07423728","CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors","Effect of Different Administration Timing of G-CSF on Peripheral Blood CD34+ Cell Mobilization in Healthy Donors: A Prospective Multicenter Randomized Controlled Trial","CHRONO-MOBILIZ","Inclusion Criteria:\n\n1. Age 18-55 years\n2. HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria\n3. Body weight ≥35 kg and adequate blood volume\u002FBSA for apheresis\n4. Karnofsky score ≥80\n5. Screening labs meet thresholds (Hb\u002Fplatelets\u002FANC, liver\u002Frenal\u002Fcoagulation), no splenomegaly, pregnancy test negative if applicable\n6. Written informed consent\n7. Stable circadian rhythm before mobilization (no night shift\u002Fno ≥3 time-zone travel; avoid melatonin\u002Fsedatives or other agents affecting sleep\u002Fcircadian rhythm)\n\nExclusion Criteria:\n\n1. Prior\u002Fcurrent hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease)\n2. Significant cardiovascular\u002Fstructural heart disease, uncontrolled hypertension, uncontrolled diabetes\n3. Neurologic\u002Fpsychiatric disorders affecting adherence\n4. Sleep\u002Fcircadian disorders; recent night shift or ≥3 time-zone travel\n5. Prohibited medications (e.g., beta-blockers, systemic steroids \\>10 mg prednisone-equivalent ≥7 days, melatonin\u002Fpsychotropics; recent G-CSF\u002FGM-CSF\u002FCXCR4 inhibitor use)\n6. Severe allergy to G-CSF or components",true,"ALL","18 Years","55 Years",{"count":108,"type":109},160,"ESTIMATED","INTERVENTIONAL",[112],"NA","Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies.\n\nThis prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells prior to apheresis in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF 10 μg\u002Fkg once daily for 5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The primary endpoint is the peripheral blood CD34+ cell count measured approximately 12 hours after the last G-CSF dose and within 60 minutes before the start of the first apheresis session. Secondary endpoints include collection efficiency and CD34+ yield metrics, the proportion of donors achieving the target CD34+ dose on the first collection day, the need for a second collection day, and donor safety outcomes.\n\nThe goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.",[115],"Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization",[117,118,119],"CD34","G-CSF","Allo-HSCT","2026-06-25",{"date":122,"type":123},"2026-06-29","ACTUAL",{"date":125,"type":123},"2026-03-01",{"date":127,"type":109},"2027-03-30",{"name":5,"class":6},3]