Romiplostim versus daily rhTPO for speeding platelet recovery after donor stem-cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, parallel-controlled Phase II trial enrolling about 74 adults to yield 66 evaluable patients with MDS or severe/very severe aplastic anemia undergoing allogeneic hematopoietic stem-cell transplant. Participants who remain platelet transfusion–dependent (platelets <20×10^9/L) between post-transplant days +4 and +10 are randomized 1:1, stratified by underlying disease, to receive once-weekly romiplostim or daily recombinant human thrombopoietin (rhTPO). Treatment starts from day +4 with dose adjustments per protocol and safety monitoring for bleeding, thrombosis, and transplant-related complications. The primary goal is to provide a preliminary estimate of efficacy for platelet engraftment and to compare safety between the two regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University, Department of Hematology
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Depei Wu Professor, Director of Hematology Department, MD
• Email: depeiwu@suda.edu.cn
• Phone: +86-512-67972861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.