Hetrombopag in Promoting Platelet Engraftment After Auto-HSCT in Children With Neuroblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hetrombopag.
- Who it may be relevant to
- Registry conditions: Delayed Platelet Engraftment, Neuroblastoma, Autologous Hematopoietic Stem Cell Transplantation. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Hetrombopag in Promoting Platelet Engraftment After Autologous Hematopoietic Stem Cell Transplantation in Children With Neuroblastoma
Overview
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.
Interventions
- Drug Hetrombopag
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\^
Primary outcome measures
- Accumulated platelet engraftment rate [Time frame: From enrollment to 60 days post-transplant]
Secondary outcome measures (4)
- Number of platelet transfusions [Time frame: From enrollment to 60 days post-transplant]
- Time to platelet engraftment [Time frame: From enrollment to 60 days post-transplant]
- progression-free survival (PFS) [Time frame: From enrollment to 60 days post-transplant]
- Adverse events [Time frame: From medication to 30 days after discontinuation]
Eligibility criteria
Inclusion criteria
- Age<18 years old;
- Diagnosed as neuroblastoma;
- ECOG ≤ 2;
- First time receiving autologous hematopoietic stem cell transplantation;
- The subjects or their legal guardians agree to participate and sign the informed consent form.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical Univ — Beijing
Identifiers
NCT: NCT06818916 · [2024]-Y-002-D