Romiplostim to help platelets grow 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

In this multicenter, randomized study, about 120 adults with hematologic diseases undergoing allo-HSCT are assigned to receive romiplostim or best supportive care. Romiplostim is given subcutaneously at 1 μg/kg once weekly starting on day +3 after transplant and continues with standard transfusion support as needed. The main goal is to see if platelet engraftment by day +30 occurs more reliably with romiplostim, defined as a platelet count over 20 x 10^9/L for seven consecutive days without transfusion. Secondary outcomes include time to platelet engraftment and safety measures. The study is investigator-initiated, prospective, and powered to detect differences between the two groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years, regardless of sex.
* Undergoing haploidentical or fully HLA-matched unrelated donor allogeneic hematopoietic stem cell transplantation for a hematologic disease.
* No severe allergic predisposition.
* No uncontrolled infection or severe psychological disorder.
* Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and bilirubin ≤2 times ULN.
* Renal function: creatinine ≤ULN.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 and an anticipated life expectancy of ≥4 months.
* Voluntary participation, with written informed consent provided by the participant or their legally authorized representative after fully understanding the study, and willingness and ability to comply with and complete all study procedures.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Known hypersensitivity to the study drug or any contraindication to its use.
* Severe hepatic impairment, defined as ALT or AST ≥5 times ULN.
* Smoking or chronic alcohol abuse that may interfere with the evaluation of study results.
* Psychiatric illness or another condition that prevents informed consent from being obtained or precludes cooperation with required treatment and examination procedures.
* Major organ surgery within the preceding six weeks.
* Any other significant medical condition, laboratory abnormality, or psychiatric disorder that, in the investigator's judgment, makes the individual unsuitable for study participation.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Li-Ping Dou, Dr.
• Email: lipingruirui@163.com
• Phone: 86-010-66937232

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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.