Single Arm Romiplostim to Prevent CIT

What Was Tested

In this early phase 1 trial, researchers set out to test Romiplostim.

The main questions it aims to answer are: 1.

It had 1 arm (groups): Romiplostim administration with chemotherapy cycles (experimental).

Enrolled patients may start romiplostim, as early as cycle 1 day 1; all patients MUST initiate romiplostim no later than 2 weeks from the start of the 5th cycle of chemotherapy. If plt count \< 200,000/mm3, patients will start romiplostim based on their weight.

The registry classes the interventions as drug.

More on the Plan

Patients will be enrolled and started on romiplostim as early as cycle 1 day 1 of their chemotherapy, but no later than 2 weeks from the start of the 5th cycle.

If their platelet count is \< 200,000/mm3, patients will start romiplostim based on their weight.

Who Took Part

The registry lists 26 planned participants were the target.

It was open to people of any sex aged from 1 Year with no upper age limit.

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

Examples of who could join: Age: Patients must be \>1 year old at the time of study consent. Diagnosis: Patients with a new diagnosis of Ewing sarcoma treated with interval-compressed chemotherapy as per AEWS0031, AEWS1221, or AEWS1031. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: concomitant therapy, non-cancer directed:; patients requiring hematopoietic stem cell rescue are not eligible; previous use of romiplostim, eltrombopag or any other platelet-producing agent is not allowed.

How the Study Was Run

It was run as a single-group and open-label study.

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 2024-01-26 with completion listed for 2027-01-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Number of evaluable participants (11 or fewer of 26) that develop CIT during the continuation phase of compressed-interval chemotherapy compared to institutional historical control rate (time frame: 52 weeks). Measure adverse events with the addition of romiplostim when given with chemotherapy (time frame: 52 weeks).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Romiplostim in 26 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.