A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
Sign a written informed consent form before enrollment;
Age range from 18 to 75 years old;
Solid tumors or hematological tumors confirmed by tissue or pathology;
CTIT patients caused by anti-tumor therapy;
Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;
Bone marrow invasion or metastasis;
Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;
Parallel
Romiplostim N01
Drug2.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication
Recombinant Human Thrombopoietin
Drug30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication
The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment
The time required for PLT to recover to 50 × 109/L or above after treatment
The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment
The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment
The lowest platelet count from receiving treatment to the end of treatment
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This trial is not recruiting at the moment. You can still explore other options:
