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

Summary

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

Eligibility

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).

Conditions2

Interventions1

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