Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

What Was Tested

The trial (phase 2) is built around Romiplostim.

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

The registry classes the interventions as drug.

More on the Plan

It is a common adverse effect of anticancer treatment, with a particularly high incidence in patients with hematologic malignancies.

Currently, aside from platelet transfusion, thrombopoietic agents are commonly used to manage CTIT.

However, there is limited evidence and a lack of prospective clinical trials investigating the use of Romiplostim in leukemia patients with CTIT.

Who Took Part

Enrollment: 97 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: 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);.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: pregnant or breastfeeding women;; known hypersensitivity to romiplostim n01;; history of severe thrombotic events or known risk factors for thrombosis, or active thromboembolism requiring anticoagulation therapy;.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

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

It started in 2025-07-14 with completion listed for 2027-01-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Platelet response at Week 2 (PLT ≥ 50×10⁹/L) (time frame: 2 weeks).

It also tracked 4 secondary outcomes, for example Early Platelet Response Rate (within 7 days), Median time to platelet recovery without transfusion, Total platelet transfusion during treatment and Platelet nadir during treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 97 people.

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.