Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia

Inclusion Criteria: * Age between 18 and 75 years, inclusive, regardless of sex; * Histologically or pathologically confirmed diagnosis of leukemia; * Patients with cancer treatment-induced thrombocytopenia (CTIT) in patients with leukemia due to antitumor therapy, with platelet count \< 50×10⁹/L; * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * 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); * Patients considered by the investigator to potentially benefit from the study treatment; * Voluntarily agrees to participate in the clinical trial, is fully informed of the study procedures, and has signed the written informed consent form. Exclusion Criteria: * Pregnant or breastfeeding women; * Known hypersensitivity to Romiplostim N01; * 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; * 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; * History of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy; * 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); * Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant human thrombopoietin (rhTPO), or interleukin-11 (IL-11) within 1 month prior to screening; * HIV infection; * Chronic active hepatitis B or hepatitis C infection; * Presence of severe infection or serious comorbidities involving the heart, liver, lungs, kidneys, nervous system, or metabolic diseases; * Participation in any investigational drug or device clinical trial within 28 days prior to baseline visit; * Subjects with cognitive impairment or uncontrolled psychiatric disorders; * Refusal of the subject and/or legal representative to receive Romiplostim N01 treatment; * 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).