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A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors
Plain-language guide to NCT04671901: phase 2 interventional trial of Romiplostim, 2 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04671901
- Phase
- phase 2
- Status
- terminated early
- Start
- 2020-12-10
- Completion (planned or actual)
- 2023-03-29
- Participants
- 2 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Solid Tumor; Solid Tumor, Childhood; Solid Carcinoma
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Romiplostim.
It had 1 arm (groups): Pediatric Participants (experimental).
Male and female patients aged 1-21 years with a primary solid tumor undergoing treatment with the pre-defined chemotherapy regimens of EFT, MAP or D9803.
The registry classes the interventions as drug.
Who Took Part
2 actual participants took part.
It was open to people of any sex aged from 1 Year up to 21 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Documented diagnosis of a primary solid tumor. Patients must have histological verification of malignancy at MSKCC. Patients undergoing treatment with MAP chemotherapy w ho have had ≥ 1 platelet transfusion during induction stage of treatment. Total Bilirubin (sum of conjugated + unconjugated) ≤ 3 times institutional upper limit of normal (ULN) for age and ALT/AST ≤ 3 times institutional ULN for age. Normal cardiac function:. Screening ECG with corrected QT (QTc) interval of \< 470 msec.
The full record lists 9 inclusion and 36 exclusion criteria; among the exclusions: patients with history of hematologic malignancies or allogenic/autogenic stem cell transplant; patients with a currently known predisposition to a myeloid stem cell disorder, myeloid leukemia, and/or bone marrow failure syndrome including, but not limited to:; aplastic anemia.
How the Study Was Run
It was run as a single-group and open-label study.
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 2020-12-10 with completion listed for 2023-03-29.
It ran at 7 sites in United States (7).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Romiplostim in 2 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.