Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

What Was Tested

This registered phase 2 trial tested Romiplostim.

Romiplostim for low platelets caused by lomustine chemotherapy in patients with first recurrence (growing back) of a brain tumor, glioblastoma that is MGMT methylated.

It had two arms (groups): Control group (active comparator) and Experimental group (experimental).

Lomustine alone.

Lomustine plus Romiplostim.

The registry classes the interventions as drug.

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 or more on day of signing informed consent. Karnofsky Performance Score (KPS) of 60-100. Life expectancy \> 8 weeks. Glioblastoma isocitrate dehydrogenase (IDH1) R132H wild-type, per cIMPACT NOW recommendations (Brat et al., 2018; Brat et al., 2020). MGMT promoter methylation determined by methylation-specific PCR or pyrosequencing or methylation profiling per local assessment.

The full record lists 26 inclusion and 20 exclusion criteria; among the exclusions: prior exposure to romiplostim or other thrombopoietin (tpo) mimetics; other hematological toxicity (anemia, neutropenia) requiring erythropoietin or gcsf; contraindications for mri, including intolerance of gadolinium as a contrast agent.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Romiplostim group and the comparison group should start out alike.

The Romiplostim group and the comparison group ran side by side rather than switching.

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.

It started in 2022-09-13 with completion listed for 2022-12-19.

It ran at 5 sites in Spain (3) and Switzerland (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression Free Survival (PFS) (time frame: 5 months after the last patient in).

It also tracked 3 secondary outcomes, for example Overall Survival (OS), the Health-related Quality of Life (HRQoL) and Frequency of worst Adverse Events (AEs).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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