Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of 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 withleukemia 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 contraceptionthroughout 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 studytreatment;

• Voluntarily agrees to participate in the clinical trial, is fully informed of thestudy 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-inducedthrombocytopenia (CTIT) caused by leukemia treatment, including but not limited toprimary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, ormyelodysplastic syndromes;

• History of thrombocytopenia due to causes other than CTIT within 6 months prior toscreening, 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 activethromboembolism requiring anticoagulation therapy;

• Severe bleeding within 2 weeks prior to screening (requiring more than 2 units ofred blood cell transfusion or a sudden ≥10% drop in hematocrit);

• Use of thrombopoietin receptor agonists (e.g., eltrombopag), recombinant humanthrombopoietin (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 daysprior to baseline visit;

• Subjects with cognitive impairment or uncontrolled psychiatric disorders;

• Refusal of the subject and/or legal representative to receive Romiplostim N01treatment;

• Deemed unsuitable for enrollment by the investigator (e.g., comorbid conditions thatmay compromise subject safety or anticipated treatment non-adherence due tofinancial or other constraints).