About this trial
The goal of this clinical trial is to learn if hetrombopag promotes platelet engraftment in neuroblastoma children undergoing autologous hematopoietic stem cell transplantation. The main question it aims to answer is:
· Does drug hetrombopag promote platelet engraftment? Participants will take hetrombopag every day for 6 weeks or until platelet \> 100\*10\^9/L.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age<18 years old;
Diagnosed as neuroblastoma;
ECOG ≤ 2;
First time receiving autologous hematopoietic stem cell transplantation;
Disqualifiers
ALT/AST > 3 ULN, or TBIL > 1.5 ULN;
Have experienced congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiring medication treatment within one year prior to enrollment, or have experienced myocardial infarction or cerebral infarction within three months prior to enrollment;
Suffering from thromboembolic diseases;
Other situations that are not suitable for inclusion in the study determined by researchers.
Trial design
Single group
Treatments tested in this trial
Hetrombopag
DrugPatients enrolled were administered Hetrombopag starting from +4d after transplantation on routine medication of recombinant human thrombopoietin injection (rhTPO). The starting dose of Hetrombopag is 2.5mg or 5mg, oral, once daily (starting at 5mg/d for body weight\>20kg; starting from 2.5mg/d for body weight ≤ 20kg). Adjust the dosage based on platelet count every two weeks, with a maximum dose of 7.5mg per day. Stop the medication after 6 weeks of continuous use or when PLT reaches 100 × 10\^9/L.
Treatment groups
Trial outcomes
Primary outcomes
Accumulated platelet engraftment rate
Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10\^9/L without platelet infusion.
Secondary outcomes
Number of platelet transfusions
Time to platelet engraftment
progression-free survival (PFS)
The time from enrollment to the first occurrence of disease progression or death from any cause
Adverse events
Any adverse events within 30 days of discontinuation
Sponsors and contacts
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