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