Romiplostim to speed platelet recovery after haploidentical stem cell transplant
Efficacy and Safety of Romiplostim N01 in Promoting Platelet Reconstruction After Haploidentical Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies
This trial will test whether weekly romiplostim helps adults with AML, MDS, or other blood cancers recover platelets faster after a haploidentical stem cell transplant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT07321626 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled Phase 1 study enrolling 130 adults undergoing haploidentical allogeneic hematopoietic stem cell transplantation for AML, MDS, or other hematologic malignancies. Participants are randomized 1:1 to receive romiplostim subcutaneously once weekly (starting 5 µg/kg with adjustments up to 10 µg/kg) for up to four weeks or until platelet counts reach ≥100 × 10⁹/L, versus a control arm without thrombopoietin receptor agonists. Supportive care including transfusions and other growth factors is permitted in both arms. The trial will monitor safety and platelet engraftment outcomes during the post-transplant period.
Who should consider this trial
Good fit: Adults (≥18 years) with AML, MDS, or other malignant hematologic diseases scheduled for haploidentical allogeneic HSCT who have ECOG 0-1, adequate liver and kidney function, and expected survival >6 months are ideal candidates.
Not a fit: Patients with uncontrolled active infection or another active malignancy, severe cardiovascular disease, those on anticoagulation, or those not undergoing haploidentical HSCT are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, romiplostim could shorten the time to platelet recovery and reduce transfusion needs and bleeding risk after haploidentical HSCT.
How similar studies have performed: Previous studies of thrombopoietin receptor agonists, including romiplostim, have shown promising signals for improving platelet counts after HSCT but results remain variable and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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. 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. Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
Where this trial is running
Hangzhou
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.