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

What Was Tested

This registered phase 2 trial tested Romiplostim.

It had 1 arm (groups): Romiplostim N01 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study was conducted in patients ≥18 years of age with a diagnosis of hematological neoplasia who underwent UCBT.

The study is planned to enroll 34 patients.

Who Took Part

34 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-12-01 with completion listed for 2026-11-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time of platelet engraftment (time frame: 28 days). The cumulative incidence of platelet engraftment at 28 days after transplantation (time frame: 28 days).

It also tracked 5 secondary outcomes, for example The cumulative incidence of platelet recovery rate at 28 days after transplantation, Time of platelet recovery, Total platelet transfusion during 4 weeks of treatment, Cumulative implantation rate of the granulocyte lineage at 28 days post-transplantation and Megakaryocyte levels in bone marrow smears 4 weeks after treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 34 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.