NCT07400341 Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
| NCT ID | NCT07400341 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | MDS (Myelodysplastic Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2026-01-31 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2026-01-31 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-65 years (inclusive). 2. 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). 3. Planned to receive allo-HSCT from a matched sibling, haploidentical, or unrelated donor (including cord blood). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. 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. 6. Adequate cardiac, hepatic, and renal function as required for transplantation, per investigator assessment. 7. Voluntary participation with written informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Active, uncontrolled bacterial, fungal, or viral infection at the time of enrollment. 2. History of arterial thrombosis, or venous thromboembolism within the past 6 months (unless cured or stable for over 6 months). 3. Active transplant-associated thrombotic microangiopathy (TA-TMA). 4. Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria). 5. Known hypersensitivity to Romiplostim, recombinant human thrombopoietin (rhTPO), or any of their excipients. 6. Pregnant or lactating women. 7. 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. 8. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07400341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying MDS (Myelodysplastic Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07400341 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07400341 currently recruiting?
Yes, NCT07400341 is actively recruiting participants. Contact the research team at depeiwu@suda.edu.cn for enrollment information.
Where is the NCT07400341 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07400341 clinical trial?
NCT07400341 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 66 participants.