Romiplostim N01 to Support Platelet Recovery After Stem Cell Transplant
Tests Romiplostim N01 for platelet recovery in adults after a stem cell transplant.
Plain-language title generated from the registry record
Registry title: Romiplostim N01 for Platelet Recovery After Haploidentical HSCT
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a blood cancer who are about to have a stem cell transplant from a half-matched family donor. It tests Romiplostim N01 to help platelet counts recover.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Blood cancer (for example acute myeloid leukemia or myelodysplastic syndromes) with a planned transplant from a half-matched donor (haploidentical); ECOG performance status 0-1; expected survival over 6 months
- Earlier treatment
- Cannot have used rh-TPO or any thrombopoietin receptor agonist within 30 days before joining
- Biomarker or test result
- Kidney and liver blood tests must be in range: serum creatinine and BUN up to 1.5 × ULN, ALT and AST up to 2 × ULN, total bilirubin up to 1.5 × ULN
Main reasons for not taking part
- Uncontrolled active infection or another active cancer
- Severe heart disease, including NYHA Class III-IV heart failure or uncontrolled blood pressure
- History of blood clots or high risk of blood clots
- Taking blood thinners for a blood clot
- Known allergy to romiplostim or similar drugs
Read by machine on 13 November 2026.
Where in China
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Yi Luo, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Affiliated Hospital of Zhejiang University
- Trial code
- NCT07321626
- Record updated
- 28 January 2026
- Original description
This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies.Read full original descriptionShow less
Efficacy and Safety of Romiplostim N01 in Promoting Platelet Reconstruction After Haploidentical Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies
This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy and safety of Romiplostim N01 in promoting platelet engraftment after haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) in patients with hematologic malignancies.
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. The treatment group will receive Romiplostim N01 subcutaneously once weekly at a starting dose of 5 µg/kg, with dose adjustments based on platelet counts (maximum 10 µg/kg), for up to 4 weeks or until platelet counts reach ≥100 × 10⁹/L. The control group will not receive rh-TPO or any thrombopoietin receptor agonist (TPO-RA) therapy. Supportive care including transfusions and growth factors (G-CSF, ESA) is allowed in both groups.
The primary endpoint is the cumulative platelet engraftment rate by day +21 post-transplant, defined as sustained platelet counts > 20 × 10⁹/L for at least 7 consecutive days without transfusion. Secondary endpoints include median time to platelet engraftment, median time to achieve platelet counts ≥ 50 × 10⁹/L and ≥ 100 × 10⁹/L, total platelet transfusion volume, erythroid and neutrophil responses within 4 weeks, and overall hematopoietic recovery. Safety endpoints include the incidence of adverse events, thromboembolic events, and treatment-related serious adverse events.
The study aims to determine whether early administration of Romiplostim N01 can accelerate platelet recovery and reduce bleeding risk in patients undergoing haplo-HSCT, thereby improving post-transplant outcomes.
Inclusion: Patients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age ≥18 years, male or female. ECOG performance status 0-1. Estimated life expectancy >6 months. Adequate renal function, defined as:serum creatinine ≤1.5 × upper limit of normal (ULN);Blood urea nitrogen (BUN) ≤1.5 × ULN; Adequate hepatic function, defined as:Alanine aminotransferase (ALT) ≤2 × ULN.Aspartate aminotransferase (AST) ≤2 × ULN.Total bilirubin ≤1.5 × ULN; Ability to understand and sign informed consent, and willingness to comply with all study requirements.
Exclusion: Receiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment; Participation in another interventional clinical study within 30 days prior to enrollment; Uncontrolled active infection or other active malignancy that could interfere with study participation; Severe cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events; Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.