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
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, ChinaTaking 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?
Trial 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.