Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA

What Was Tested

This registered phase 2 trial tested Romiplostim for anemia.

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

The registry classes the interventions as drug.

More on the Plan

Currently, there are few studies on the use of TPO-RAs after tumor radiotherapy and chemotherapy.

Who Took Part

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 ≥ 18 years old;. With baseline liver and kidney functions \<2 ULN;. Without active infection that cannot be controlled by standard treatment;. Signed the informed consent;. ECOG score ≤ 2;.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: had other primary or secondary bone marrow failure (bmf) diseases, such as fanconi anemia, congenital keratinization disorder, etc.;; with evidence of clonal hematological bone marrow diseases (mds, aml) in cytogenetics;; received hsct before enrollment;.

How the Study Was Run

The set-up was 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 2026-06 with completion listed for 2028-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ORR (time frame: 3-month, 6-month).

It also tracked 4 secondary outcomes, for example CRR, AE rate and Clonal evolution rate.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, Anemia research.