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;
Single group
Romiplostim N01
DrugRomiplostim N01 will be administered via subcutaneous injection once weekly when patients develop Grade 3 thrombocytopenia (platelet count \< 50×10⁹/L) following leukemia treatment. The recommended initial dose is 5 µg/kg, with a maximum single dose not exceeding 250 µg. Treatment may continue for up to 8 doses.
Platelet response at Week 2 (PLT ≥ 50×10⁹/L)
Proportion of patients achieving a platelet count ≥ 50×10⁹/L at 2 weeks after initiation of treatment.
Early Platelet Response Rate (within 7 days)
Proportion of patients achieving a response within 7 days of treatment initiation (Response defined as: no requirement for platelet transfusion and either a platelet count increase to ≥ 50×10⁹/L, at least a two-fold increase from baseline, or a platelet count ≥ 100×10⁹/L.)
Median time to platelet recovery without transfusion
Median time to achieve platelet counts of ≥ 50×10⁹/L and ≥ 100×10⁹/L without platelet transfusion.
Total platelet transfusion during treatment
Total platelet transfusion during treatment
Platelet nadir during treatment
Nadir platelet count during the treatment period (from initiation to end of treatment)
Incidence of adverse events
Incidence of adverse events
Incidence of bleeding events
Incidence of bleeding events (based on World Health Organization bleeding assessment scale)
Survival outcomes
Relapse-Free Survival (RFS), Overall Survival (OS), and Cumulative Incidence of Relapse (CIR)
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