Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Active transplant-associated thrombotic microangiopathy (TA-TMA).
Pre-transplant bone marrow biopsy showing fibrosis grade ≥ MF-2 (according to WHO criteria).
Trial design
Treatments tested in this trial
- Romiplostim
- Recombinant Human Thrombopoietin
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov