[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610933":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"rituximab combined with Daratumumab（anti-CD38 monoclonal antibody）","EXPERIMENTAL","Rituximab (375mg\u002Fm2) was given once (day1) and a Daratumumab (16mg\u002Fkg) was given four times (day8,15,22,29).",[13,14],"Drug: Daratumumab（Anti-CD38 Monoclonal Antibody）","Drug: Rituximab",{"label":16,"type":17,"description":18,"interventionNames":19},"rituximab","ACTIVE_COMPARATOR","Rituximab (375mg\u002Fm2) was given once.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Daratumumab（Anti-CD38 Monoclonal Antibody）","All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), rituximab (375mg\u002Fm2) was given once (day1) and Daratumumab (16mg\u002Fkg) was given four times (day8,15,22,29).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rituximab","All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group A (active comparator) , rituximab (375mg\u002Fm2) was given once. For subjects in group B (experimental), rituximab (375mg\u002Fm2) was given once (day1) and anti-CD38 monoclonal antibody (16mg\u002Fkg) was given four times (day8,15,22,29).",[16,9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Lei Zhang, MD","CONTACT","+8613502118379","zhanglei1@ihcams.ac.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Yunfei Chen, MD","+8618502220788","chenyunfei@ihcams.ac.cn",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Chinese Academy of Medical Science and Blood Disease Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},[57,59],{"name":33,"role":34,"phone":58,"phoneExt":26,"email":36},"+8602223909009",{"name":38,"role":34,"phone":60,"phoneExt":26,"email":40},"+8602223909240",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100610933","phase-2-rituximab-combining-anti-cd38-monoclonal-antibody-versus-rituximab-in-the-management-of-primary-immune-thrombocytopenia-itp-100610933",false,"NCT07234019","Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)","A Randomized, Open-label Study To Compare The Efficacy And Safety Of Rituximab Combining Anti-CD38 Monoclonal Antibody Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.\n* Subjects with a platelet count of \\\u003C30×10\\^9\u002FL within the 48 hours prior to the first dose of the study drug;The platelet count of at least two separate assessments (at least 1 week apart) \\\u003C30×10\\^9\u002FL during the screening visit.\n* Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse).\n* Previous emergency treatment for ITP (e.g., methylprednisolone, platelet, gamma globulin infusion) must have been completed at least 2 weeks before the first dose.\n* Hepatic and renal function (e.g., alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatinine) \\\u003C1.5 times the upper limit of normal (ULN).\n* ECOG performance status score of ≤2.\n* Cardiac function: New York Heart Association (NYHA) class ≤2.\n* Enrollment of subjects receiving maintenance therapy is permitted, including glucocorticoids (≤0.5 mg\u002Fkg of prednisone or equivalent) or TPO receptor agonists, but the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug; Azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first dose; CD20 monoclonal antibody such as rituximab must have been stopped for more than 6 months; the interval between splenectomy and first administration need to be more than 6 months.\n* For fertile female patients, a negative pregnancy test result is required. Fertile female and male patients must use effective contraception separately during the study and for 90 days after the cessation of study drug treatment.\n* Subjects comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.\n\nExclusion Criteria:\n\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases.\n* HIV positive.\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive.\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc..\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled.\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis.\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past.\n* atients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up.\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared.\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.).\n* Patients with septicemia or other irregular severe bleeding.\n* Patients taking antiplatelet drugs at the same time.\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.\n* Subjects with a known allergy to medications were used in the trial or excipients.\n* Any other conditions unsuitable for participation in this study, as assessed by the investigator.","ALL","18 Years",{"count":73,"type":74},160,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This randomized, open-label study aim to compare the efficacy and safety of rituximab combining anti-CD38 monoclonal antibody with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.",[80,81],"Immune Thrombocytopenia","Treatment","2026-02-09",{"date":84,"type":85},"2026-02-11","ACTUAL",{"date":87,"type":85},"2026-01-28",{"date":89,"type":74},"2028-11",{"name":5,"class":6},1]