Compares romiplostim and rhTPO to help platelets recover after stem cell transplant
Tests two platelet-boosting drugs in adults with MDS or aplastic anemia after transplant.
Plain-language title generated from the registry record
Registry title: Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
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 aged 18-65 with myelodysplastic syndrome (MDS) or severe aplastic anemia who are about to have a donor stem cell transplant and still have very low platelets after it.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- MDS (by WHO criteria) or severe or very severe aplastic anemia (by Camitta criteria), and able to have a donor stem cell transplant. ECOG performance status 0-2.
- Earlier treatment
- A planned donor stem cell transplant from a matched sibling, haploidentical or unrelated donor (including cord blood). Between days +4 and +10 after the transplant, platelets stay below 20×10⁹/L and platelet transfusions are still needed.
- Biomarker or test result
- Platelet count below 20×10⁹/L after the transplant, with dependence on platelet transfusions.
Main reasons for not taking part
- Active infection that is not under control
- Arterial blood clot ever, or a vein clot in the past 6 months (unless stable for over 6 months)
- Active transplant-associated thrombotic microangiopathy (TA-TMA)
- Bone marrow biopsy before the transplant showing fibrosis grade MF-2 or higher
- Known allergy to romiplostim or rhTPO, or pregnancy or breastfeeding
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07400341, who can take part
Where in China
- The First Affiliated Hospital of Soochow University, Department of HematologySuzhou, ChinaContact: Clinical Trial Coordinator, Hematology DepartmentTaking 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
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07400341
- Record updated
- 15 April 2026
- Original description
This study is for adults aged 18-65 with myelodysplastic syndrome (MDS) or severe aplastic anemia (AA) who are scheduled to receive a donor stem cell transplant (allogeneic hematopoietic stem cell transplant). After the transplant, it is critical for the body to start making its own blood cells again. A common and serious problem is a delay in the recovery of platelets (the cells that help stop bleeding), which increases the risk of bleeding, infection, and death.Read full original descriptionShow less
A Randomized Phase II Study of Romiplostim vs. rhTPO for Platelet Engraftment After Allo-HSCT in Patients With MDS and Aplastic Anemia (PROMPT)
This study is for adults aged 18-65 with myelodysplastic syndrome (MDS) or severe aplastic anemia (AA) who are scheduled to receive a donor stem cell transplant (allogeneic hematopoietic stem cell transplant). After the transplant, it is critical for the body to start making its own blood cells again. A common and serious problem is a delay in the recovery of platelets (the cells that help stop bleeding), which increases the risk of bleeding, infection, and death.
This study aims to see if a new treatment can help platelets recover faster and more safely after transplant. We are comparing two drugs:
Romiplostim: A long-acting injection given just once a week. rhTPO (Recombinant Human Thrombopoietin): A standard injection given every day. Both drugs are designed to help the body make more platelets. The main question is whether the once-weekly romiplostim works as well or better than the daily rhTPO, and if it is safe.
About 66 patients will participate. By random chance (like flipping a coin), each participant will be assigned to receive either romiplostim or rhTPO. The treatment will start a few days after the transplant and continue until platelets recover to a safe level or for up to 8 weeks. Doctors will closely monitor all participants for 100 days to track platelet recovery, need for transfusions, side effects, and overall health.
Inclusion: Age 18-65 years (inclusive); Diagnosis of Myelodysplastic Syndrome (MDS) per WHO criteria, or Severe/Very Severe Aplastic Anemia (SAA/VSAA) per Camitta criteria, and deemed eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT); Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Persistent platelet count <20×10⁹/L with platelet transfusion dependence between post-transplant days +4 and +10. Transfusion dependence is defined as platelet count not doubling within 24-48 hours after transfusion or ongoing need for prophylactic transfusion; Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment; Voluntary participation with written informed consent obtained prior to any study-specific procedures.
Exclusion: Active transplant-associated thrombotic microangiopathy (TA-TMA); Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria); Women of childbearing potential or men with partners of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 3 months after the last dose of study drug; Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment; History of arterial thrombosis, or venous thromboembolism within the past 6 months (unless cured or stable for over 6 months); Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients; Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study; Pregnant or lactating women.