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Romiplostim N01 for Platelet Recovery After Haploidentical HSCT
Plain-language guide to NCT07321626: phase 1 randomized trial of Romiplostim, 130 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07321626
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2025-06-01
- Completion (planned or actual)
- 2027-12
- Participants
- 130 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Acute Myeloid Leukemia; MDS (Myelodysplastic Syndrome); Delayed Platelet Engraftment; HSCT
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Romiplostim.
A total of 130 patients who undergo haplo-HSCT for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or other hematologic malignancies will be enrolled and randomized 1:1 into a treatment group and a control group.
It had two arms (groups): Romiplostim N01 Treatment Arm (experimental) and Standard Care Control Arm (active comparator).
The registry classes the interventions as drug and other.
Who Took Part
130 planned participants were the target.
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.
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 2025-06-01 with completion listed for 2027-12.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Cumulative Platelet Engraftment Rate by Day +21 after Haploidentical HSCT (time frame: Within 21 days after transplantation).
It also tracked 6 secondary outcomes, for example Time to Platelet Engraftment, Proportion of Patients Achieving Platelet Counts ≥50 × 10⁹/L and ≥100 × 10⁹/L, Median Time to Achieve Platelet Count ≥100 × 10⁹/L during the 4-Week Treatment Period, Total Platelet Transfusion Volume, Proportion of Participants with Erythroid Response during the 4-Week Treatment Period and Proportion of Participants with Neutrophil Response during the 4-Week Treatment Period.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Romiplostim in 130 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.
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.