Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia
Cancer treatment-induced thrombocytopenia (CTIT) refers to a decrease in platelet count caused by antitumor therapies during cancer treatment. It is a common adverse effect of anticancer treatment, with a particularly high incidence in patients with hematologic malignancies. CTIT increases the risk of bleeding, may limit treatment options, and can ultimately compromise the effectiveness of cancer therapy and reduce long-term survival. Currently, aside from platelet transfusion, thrombopoietic agents are commonly used to manage CTIT. Studies have shown that Romiplostim demonstrates a response rate of up to 71% in patients with chemotherapy-induced thrombocytopenia from solid tumors, with 89% of patients avoiding the need for platelet transfusion, thereby significantly reducing the risk of bleeding. However, there is limited evidence and a lack of prospective clinical trials investigating the use of Romiplostim in leukemia patients with CTIT. This study aims to evaluate the efficacy and safety of Romiplostim in adult leukemia patients with CTIT, in order to provide new therapeutic options and strategies, and ultimately improve the quality of life for this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Romiplostim 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.
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
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.
Time frame: 2 weeks
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.)
Time frame: 7 days
Median time to platelet recovery without transfusion
Median time to achieve platelet counts of ≥ 50×10⁹/L and ≥ 100×10⁹/L without platelet transfusion.
Time frame: 8 weeks
Total platelet transfusion during treatment
Total platelet transfusion during treatment
Time frame: 8 weeks
Platelet nadir during treatment
Nadir platelet count during the treatment period (from initiation to end of treatment)
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.