Romiplostim to speed platelet recovery after haploidentical 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, controlled Phase 1 study enrolling 130 adults undergoing haploidentical allogeneic hematopoietic stem cell transplantation for AML, MDS, or other hematologic malignancies. Participants are randomized 1:1 to receive romiplostim subcutaneously once weekly (starting 5 µg/kg with adjustments up to 10 µg/kg) for up to four weeks or until platelet counts reach ≥100 × 10⁹/L, versus a control arm without thrombopoietin receptor agonists. Supportive care including transfusions and other growth factors is permitted in both arms. The trial will monitor safety and platelet engraftment outcomes during the post-transplant period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with malignant hematologic diseases scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) Age ≥18 years, male or female. ECOG performance status 0-1. Estimated life expectancy \>6 months. Adequate renal function, defined as:serum creatinine ≤1.5 × upper limit of normal (ULN);Blood urea nitrogen (BUN) ≤1.5 × ULN.

Adequate hepatic function, defined as:Alanine aminotransferase (ALT) ≤2 × ULN.Aspartate aminotransferase (AST) ≤2 × ULN.Total bilirubin ≤1.5 × ULN.

Ability to understand and sign informed consent, and willingness to comply with all study requirements.

Exclusion Criteria:

Uncontrolled active infection or other active malignancy that could interfere with study participation.

Severe cardiovascular disease, including:New York Heart Association (NYHA) Class III-IV heart failure;Uncontrolled hypertension or hypotension;History of or high risk for thromboembolic events.

Receiving anticoagulation therapy for thrombotic events. Known hypersensitivity to romiplostim or similar agents. Use of rh-TPO or any thrombopoietin receptor agonist (TPO-RA) within 30 days prior to enrollment.

Participation in another interventional clinical study within 30 days prior to enrollment.

Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Where it's running

• The First Affiliated Hospital, College of Medicine, Zhejiang University
  Hangzhou, China Recruiting

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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.