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

Launched by ANHUI PROVINCIAL HOSPITAL · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Romiplostim N01 for patients with leukemia who are experiencing a condition known as cancer treatment-induced thrombocytopenia (CTIT). This condition means that the chemotherapy or other cancer treatments have caused a low platelet count, which can lead to easy bruising or bleeding. The trial aims to see how effective and safe Romiplostim N01 is in increasing platelet counts in these patients.

To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of leukemia. They should also have a low platelet count (less than 50,000 platelets per microliter of blood) due to their cancer treatment. Participants will need to agree to use reliable contraception if they are capable of becoming pregnant. While the study is not yet recruiting, those who join can expect to receive close monitoring and care from the research team during the trial. It's important to note that certain individuals, such as pregnant women or those with specific medical conditions, will not be eligible to participate.

Gender

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Eligibility criteria

• 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).