NCT07400341RecruitingPhase 2
Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
A Randomized Phase II Study of Romiplostim vs. rhTPO for Platelet Engraftment After Allo-HSCT in Patients With MDS and Aplastic Anemia (PROMPT)
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 31 Jan 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07400341
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 31 Jan 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University, Department of Hematology Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.