Romiplostim N01 for leukemia-related CTIT in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial evaluates the safety and effectiveness of Romiplostim N01 in adult leukemia patients experiencing cancer treatment-induced thrombocytopenia. Participants have platelet counts below 50×10^9/L and an ECOG performance status of 0–2. The study aims to determine if Romiplostim N01 can raise platelets and reduce bleeding risk, potentially decreasing the need for platelet transfusions while maintaining cancer treatment plans. Enrollment is limited to adults aged 18–75 at a single lead site in China with appropriate consent.

Why it matters

Who can join: the full rules

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).

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Xiaoyu Zhu, Ph.D — The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
• Study coordinator: Xiaoyu Zhu, Ph.D
• Email: xiaoyuz@ustc.edu.cn
• Phone: 0551-62283347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.