Using Romiplostim N01 to help platelet recovery after umbilical cord blood transplantation

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 clinical trial evaluates the efficacy and safety of Romiplostim N01 in promoting platelet recovery in adult patients with hematologic malignancies who have undergone umbilical cord blood transplantation (UCBT). It is a single-center, single-arm Phase II trial that aims to enroll 34 patients aged 18 and older. Participants will receive Romiplostim N01 from day +1 to day +28 post-transplantation, with the primary efficacy measure being the cumulative platelet implantation rate at 28 days after UCBT. The study seeks to address the common complication of persistent thrombocytopenia following transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥12 years old, male or female;
* Patients diagnosed with hematological malignancies and undergoing UCBT;
* ECOG score ≤2;
* Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent

Exclusion Criteria:

* Pregnant or lactating women；
* Known allergy to Romiplostim N01;
* A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
* A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
* Chronic active hepatitis B and C;
* Repeat or multiple transplantation or multiple organ transplantation;
* HIV positive, EBV-DNA positive, CMV-DNA positive;
* Have severe infection or complicated with serious heart, liver, lung, kidney, neurological or metabolic diseases;
* A serious adverse event (Level 4 or 5) as defined by the Standard General Terminology for Adverse Events Version 4.0 occurred during the pre-treatment period;
* Participants participate in another clinical study with any exploratory drug or device within 30 days prior to baseline visit; Observational studies are allowed;
* Subjects with cognitive impairment or uncontrolled mental illness;
* Subjects and/or authorized family members to refuse treatment with Romiplostim N01;
* Those who are judged by the researchers as not suitable for inclusion (such as accompanying medical history, which may affect the safety of the subjects or it is estimated that the treatment cannot be adhered to due to financial problems).

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Xiaoyu Zhu, ph.D
• Email: xiaoyuz@ustc.edu.cn
• Phone: 15255456091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Avatrombopag to Help Platelet Recovery After Cord Blood Transplantation

  This study is testing if a medication called Avatrombopag can help people with bone marrow failure recover their platelet levels after receiving a cord blood transplant.

  Recruiting Anhui Provincial Hospital · Hefei, Anhui · NCT05823376

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.