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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated platelet engraftment rate | Platelet engraftment is defined as a continuous 7-day PLT ≥ 20 × 10^9/L without platelet infusion. | From enrollment to 60 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of platelet transfusions | From enrollment to 60 days post-transplant | |
| Time to platelet engraftment | From enrollment to 60 days post-transplant | |
| progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yang | Contact | 86-010-59617614 | yangjundabby@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Stem Cell Transplantation, Beijing Children's Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C000614661 | hetrombopag |
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|
The time from enrollment to the first occurrence of disease progression or death from any cause |
| From enrollment to 60 days post-transplant |
| Adverse events | Any adverse events within 30 days of discontinuation | From medication to 30 days after discontinuation |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |