[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-treatment-induced-thrombocytopenia-ctit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-treatment-induced-thrombocytopenia-ctit":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100585178","phase-2-efficacy-and-safety-study-of-romiplostim-n01-for-cancer-treatment-induced-thrombocytopenia-ctit-in-the-treatment-of-leukemia-100585178",false,"NCT06898983","Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, regardless of sex;\n* Histologically or pathologically confirmed diagnosis of leukemia;\n* Patients with cancer treatment-induced thrombocytopenia (CTIT) in patients with leukemia due to antitumor therapy, with platelet count \\\u003C 50×10⁹\u002FL;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Subjects of childbearing potential agree to use reliable methods of contraception throughout the study period (including male or female condoms, contraceptive foam, gel, film, cream, suppository, abstinence, or intrauterine device);\n* Patients considered by the investigator to potentially benefit from the study treatment;\n* Voluntarily agrees to participate in the clinical trial, is fully informed of the study procedures, and has signed the written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Known hypersensitivity to Romiplostim N01;\n* Presence of hematologic disorders other than cancer treatment-induced thrombocytopenia (CTIT) caused by leukemia treatment, including but not limited to primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;\n* History of thrombocytopenia due to causes other than CTIT within 6 months prior to screening, including but not limited to chronic liver disease, hypersplenism, infections, or bleeding disorders;\n* History of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy;\n* Severe bleeding within 2 weeks prior to screening (requiring more than 2 units of red blood cell transfusion or a sudden ≥10% drop in hematocrit);\n* Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 1 month prior to screening;\n* HIV infection;\n* Chronic active hepatitis B or hepatitis C infection;\n* Presence of severe infection or serious comorbidities involving the heart, liver, lungs, kidneys, nervous system, or metabolic diseases;\n* Participation in any investigational drug or device clinical trial within 28 days prior to baseline visit;\n* Subjects with cognitive impairment or uncontrolled psychiatric disorders;\n* Refusal of the subject and\u002For legal representative to receive Romiplostim N01 treatment;\n* Deemed unsuitable for enrollment by the investigator (e.g., comorbid conditions that may compromise subject safety or anticipated treatment non-adherence due to financial or other constraints).","ALL","18 Years","75 Years",{"count":19,"type":20},97,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia",[26],"Cancer Treatment-induced Thrombocytopenia (CTIT)","RECRUITING","2026-07-09",{"date":30,"type":31},"2026-07-10","ACTUAL",{"date":33,"type":31},"2025-07-14",{"date":35,"type":20},"2027-02-28",{"name":37,"class":38},"Anhui Provincial Hospital","OTHER_GOV"]