Actively Recruiting
Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-15
66
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years inclusive
- Diagnosed with myelodysplastic syndrome (MDS) or severe/very severe aplastic anemia (SAA/VSAA)
- Scheduled for allogeneic hematopoietic stem cell transplantation from matched sibling, haploidentical, or unrelated donor (including cord blood)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Persistent platelet count below 20 x 10⁹/L with dependence on platelet transfusions between days +4 and +10 after transplant
- Adequate heart, liver, and kidney function for transplantation as assessed by investigator
- Voluntary participation with written informed consent obtained
You will not qualify if you...
- Active, uncontrolled bacterial, fungal, or viral infection at enrollment
- History of arterial thrombosis or venous thromboembolism within the past 6 months unless stable over 6 months
- Active transplant-associated thrombotic microangiopathy (TA-TMA)
- Bone marrow fibrosis grade 2 or higher before transplant
- Known allergy to romiplostim, recombinant human thrombopoietin (rhTPO), or their components
- Pregnant or breastfeeding women
- Women of childbearing potential or men with partners of childbearing potential not willing to use effective contraception during study and for 3 months after last dose
- Any other condition judged by the investigator to make participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University, Department of Hematology
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
D
Depei Wu Professor, Director of Hematology Department, MD
CONTACT
X
Xiaojin Wu Associate Professor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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