[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548925":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":38,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":11,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Inotuzumab ozogamicin","EXPERIMENTAL",null,[13],"Drug: Inotuzumab ozogamicin",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","1. st dose is given after D+60：inotuzumab 0.3mg\u002Fm2\n2. nd dose is given after 1 month：inotuzumab 0.6mg\u002Fm2",[9],[20],{"facility":21,"status":22,"city":23,"state":11,"zip":11,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","RECRUITING","Tianjin","China","CN",{"type":27,"coordinates":28},"Point",[29,30],117.17667,39.14222,{"lat":30,"lon":29},[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Erlie Jiang","CONTACT","+86-15122538106","jiangerlie@ihcmas.ac.cn",{"type":39,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100548925","phase-2-phase-ii-study-of-post-transplant-low-dose-inotuzumab-ozogamicin-to-prevent-relapse-of-acute-lymphoblastic-leukemia-100548925",false,"NCT06427330","Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia","Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia\n* Patients who are after T+60 after transplantation\n* Patients who have\u002Fare either:\n\n  * High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic\n  * Leukemia\n  * Relapsed or refractory to at least 1 line of treatment\n  * Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test\n* Patients who have \\> 99% donor chimerism after allogeneic transplantation.\n* Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* ≥ 18 years old, including male and female\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with evidence of disease progression prior to enrollment\n* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)\n* Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:\n\n  * Severe renal deficiency, with creatinine clearance \\\u003C 50ml\u002Fmin\n  * Severe hepatic deficiency\n  * Bilirubin, aspartate aminotransferase(AST), and\u002For ALT(ALT) \\> 2X institutional upper limit of normal\n  * Severe cardiac or pulmonary deficiency\n* Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).\n* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)\n* History of veno-occlusive disease(VOD)\n* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds","ALL","18 Years",{"count":50,"type":51},21,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.",[57],"Acute Lymphoid Leukemia","2024-07-28",{"date":60,"type":61},"2024-07-30","ACTUAL",{"date":63,"type":61},"2024-07-02",{"date":65,"type":51},"2026-06-30",{"name":5,"class":6},1]