Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorBeijing Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Hetrombopag

    Drug

    Patients 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

30 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accumulated platelet engraftment rate

Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10\^9/L without platelet infusion.

Time frame
From enrollment to 60 days post-transplant

Secondary outcomes

1

Number of platelet transfusions

Time frame
From enrollment to 60 days post-transplant
2

Time to platelet engraftment

Time frame
From enrollment to 60 days post-transplant
3

progression-free survival (PFS)

The time from enrollment to the first occurrence of disease progression or death from any cause

Time frame
From enrollment to 60 days post-transplant
4

Adverse events

Any adverse events within 30 days of discontinuation

Time frame
From medication to 30 days after discontinuation

Other outcomes

Sponsors and contacts

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