Using Romiplostim N01 to help platelet recovery after umbilical cord blood transplantation

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

This study is testing if a medication called Romiplostim N01 can help adults recover their platelet levels faster after receiving umbilical cord blood transplants.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06693791 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Romiplostim N01 in promoting platelet recovery in adult patients with hematologic malignancies who have undergone umbilical cord blood transplantation (UCBT). It is a single-center, single-arm Phase II trial that aims to enroll 34 patients aged 18 and older. Participants will receive Romiplostim N01 from day +1 to day +28 post-transplantation, with the primary efficacy measure being the cumulative platelet implantation rate at 28 days after UCBT. The study seeks to address the common complication of persistent thrombocytopenia following transplantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with hematological malignancies who are undergoing umbilical cord blood transplantation.

Not a fit: Patients with a history of severe thrombotic events, active infections, or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve platelet recovery and reduce complications in patients undergoing UCBT.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in using Romiplostim for platelet recovery in other settings.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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).

Where this trial is running

Hefei, Anhui

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

Study contacts

• Study coordinator: Xiaoyu Zhu, ph.D

Conditions Platelet Recovery After Umbilical Cord Blood Transplantation