Can a Platelet-Boosting drug speed recovery after stem cell transplant?
NCT ID NCT07829952
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
After an allogeneic stem cell transplant, patients often face weeks with dangerously low platelets and need frequent transfusions. This trial tests whether romiplostim, a drug that stimulates platelet production, helps platelets recover faster. Researchers randomly assign 87 adults with blood cancers to receive weekly romiplostim injections or standard care alone. The main goal is to measure how long it takes for platelet counts to stay above a safe threshold without transfusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- romiplostim, a drug that boosts platelet production
- What this could lead to
- If it works, romiplostim could shorten the dangerous window after a stem cell transplant when patients have too few platelets and need transfusions.
- What could go wrong
- This is a single-center Phase 2 trial with 87 participants, so results may not hold in larger or more diverse groups. Romiplostim can raise the risk of blood clots and may interact with other post-transplant medicines.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 87 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1.Subjects must understand study procedures, be willing to comply with the study protocol, and provide written informed consent prior to any study-related procedures. 2\. Age ≥18 years, male or female. 3. Patients with hematological malignancies undergoing allogeneic hematopoietic stem-cell transplantation (allo-HSCT). 4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function defined as follows: * Serum bilirubin ≤ 2 mg/dL, unless due to benign congenital hyperbilirubinemia; * AST, ALT and alkaline phosphatase \< 3 × upper limit of normal (ULN); * Creatinine clearance ≥ 40 mL/min (calculated by the Cockcroft-Gault formula); * Left ventricular ejection fraction (LVEF) ≥ 45% by MUGA scan or resting echocardiogram; * Pulmonary function: FEV1 and corrected DLCO ≥45% of predicted value. 6. Participants of reproductive potential must use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, contraceptive suppositories, abstinence, intrauterine device, etc.). Exceptions include female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or are postmenopausal for more than 1 year; and male participants with bilateral vasectomy. Exclusion Criteria: * 1\. Subjects who have received romiplostim, eltrombopag, or other TPO-RA thrombopoietic agents within 1 month prior to enrollment. 2\. History of symptomatic or incidental venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism), except patients who received and tolerated anticoagulation within the preceding 6 months, completed anticoagulation \>6 months ago, or are receiving ongoing anticoagulation. Patients with central venous catheter-related venous thromboembolic events are excluded. 3\. Patients with a history of symptomatic arterial thrombotic events including myocardial infarction, ischemic cerebrovascular accident, or transient ischemic attack within the preceding 6 months. 4\. Patients with severe underlying diseases that may interfere with the conduct of the study, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring intravenous antibiotic therapy. 5\. Abnormal hepatic or renal function: total bilirubin \> 2 × upper limit of normal (ULN); AST or ALT \> 1.5 × ULN; creatinine \> 1.5 × ULN; estimated glomerular filtration rate \< 30 mL/min/1.73 m². 6\. Patients with positive hepatitis C antibody plus elevated HCV-RNA; patients with positive hepatitis B surface antigen plus elevated HBV-DNA; patients with severe liver cirrhosis; patients with positive HIV antibody or positive syphilis antibody. 7\. Subjects with known hypersensitivity or intolerance to the active ingredient or excipients of injectable Romiplostim N01. 8.Participation in any other interventional clinical study of investigational drugs or devices within 1 month prior to screening. 9\. Female subjects who are pregnant or breastfeeding. 10. Subjects who, in the investigator's judgment, are unable to comply with study procedures, or for whom study participation is otherwise deemed inappropriate by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471023, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a detailed health check predict who thrives after a stem cell transplant?
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?