[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553782":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":23,"responsibleParty":33,"collaborators":23,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":23,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":23,"maxAge":23,"enrollmentInfo":43,"targetDuration":23,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":23,"overallStatus":52,"whyStopped":23,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":23},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"PDCy group","Low dose Cy 30 mg\u002Fkg\u002Fd was administered on the 3rd and 4th day after gDLI to prevent GVHD",[12],"Drug: PDCy",{"label":14,"type":6,"description":15,"interventionNames":16},"Non Cy group","Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI",[17],"Drug: Non Cy",[19,24],{"type":20,"name":21,"description":10,"armGroupLabels":22,"otherNames":23},"DRUG","PDCy",[9],null,{"type":20,"name":25,"description":15,"armGroupLabels":26,"otherNames":23},"Non Cy",[14],[28],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"erlie jiang, MD","CONTACT","+86-15122538106","jiangerlie@ihcams.ac.cn",{"type":34,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100553782","low-dose-cyclophosphamide-or-cni-in-the-prevention-of-acute-graft-versus-host-disease-after-gdli-100553782",false,"NCT06490562","Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI","A Prospective Multicenter Randomized Controlled Clinical Trial Protocol for the Efficacy and Safety of Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI","Inclusion Criteria:\n\n* Subjects eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Patients with malignant hematological diseases undergo haploid\u002Fsibling incomplete matching\u002Funrelated donor transplantation;\n  2. Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);\n  3. Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;\n  4. No age, gender, or race restrictions;\n  5. The physical condition assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;\n  6. The patient or their authorized representative agrees to participate in the clinical trial and signs an informed consent form.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria are not eligible for inclusion in this study:\n\n  1. Siblings of matched donor transplant;\n  2. Patients with other malignant tumors that require treatment;\n  3. There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;\n  4. HIV serological reaction was positive;\n  5. Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;\n  6. Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;\n  7. Active heart disease is defined as one or more of the following:\n\n     1. Have a history of uncontrolled or symptomatic angina pectoris;\n     2. Myocardial infarction less than 6 months prior to enrollment in the study;\n     3. A history of arrhythmia requiring medication treatment or severe clinical symptoms;\n     4. Uncontrolled or symptomatic congestive heart failure (\\>NYHA level 2);\n     5. The ejection fraction is below the lower limit of the normal range.\n  8. Individuals who are allergic to any medication or component such as Cy, CNI, etc;\n  9. The researchers believe that it is not suitable for participants.","ALL",{"count":44,"type":45},66,"ESTIMATED","INTERVENTIONAL",[48],"NA","Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological\u002Fextramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.",[51],"Acute Graft-versus-host Disease","NOT_YET_RECRUITING","2024-06-28",{"date":55,"type":56},"2024-07-08","ACTUAL",{"date":58,"type":45},"2024-07",{"date":60,"type":45},"2028-12",{"name":5,"class":6}]