RecruitingPhase 2NCT06693791

Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

Efficacy and Safety of a Long-acting Thrombopoietin Receptor Agonist for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing Umbilical Cord Blood Transplantation


Sponsor

Anhui Provincial Hospital

Enrollment

34 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥12 years old, male or female;
  • Patients diagnosed with hematological malignancies and undergoing UCBT;
  • ECOG score ≤2;
  • Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent

Exclusion Criteria13

  • Pregnant or lactating women;
  • Known allergy to Romiplostim N01;
  • A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
  • A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
  • Chronic active hepatitis B and C;
  • Repeat or multiple transplantation or multiple organ transplantation;
  • HIV positive, EBV-DNA positive, CMV-DNA positive;
  • Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
  • A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
  • Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
  • Subjects with cognitive impairment or uncontrolled mental illness;
  • Subjects and/or authorized family members to refuse treatment with Romiplostim N01;
  • Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).

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Interventions

DRUGRomiplostim N01

Romiplostim N01 was administered subcutaneously once weekly from +1 day to +28 days after UCBT at a recommended starting dose of 5µg/Kg (maximum single dose not to exceed 250µg) for a total of 4 administrations, with the option of continuation of dosing/switching/discontinuing after +28 days, depending on the patient's platelet profile.


Locations(1)

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

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NCT06693791


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