Status:
NOT_YET_RECRUITING
Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Cancer Treatment-induced Thrombocytopenia (CTIT)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Evaluation of the Efficacy and Safety of Romiplostim N01 for the Treatment of Cancer Treatment-Induced Thrombocytopenia (CTIT) in Patients with Leukemia
Detailed Description
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, wi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT06898983
Start Date
March 31 2025
End Date
February 28 2027
Last Update
March 28 2025
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036