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Selinexor Combined With Induction Chemotherapy for Children With NUP98-positive AML
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Summary
This is a prospective, single-arm, open-label clinical study to evaluate the efficacy and safety of Selinexor combined with a standardized induction chemotherapy regimen (ZJCH-AML) for children with NUP98-fusion positive Acute Myeloid Leukemia (AML). NUP98-fusion positive AML is a high-risk subtype in pediatric patients, characterized by poor prognosis and high relapse rates under traditional chemotherapy. Preliminary research suggests that Selinexor, an XPO1 inhibitor, can selectively inhibit NUP98-driven leukemia cells. This study aims to determine if adding Selinexor to standardized chemotherapy can increase the complete remission rate and improve the overall survival for these specific high-risk patients.
Official title: Clinical Study of Selinexor Combined With ZJCH-AML Induction Chemotherapy for the Treatment of NUP98-positive Pediatric Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-01-01
Completion Date
2027-12-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Selinexor
Induction Course 1: 40mg/m² orally on Days 1, 3, 8, and 10. Induction Course 2: 40mg/m² orally on Days 1 and 3.
ZJCH-AML Standardized Chemotherapy
Course 1 (HAG): Homoharringtonine (HHT) 2mg/m²/d, Cytarabine (Ara-C) 10mg/m² q12h, and G-CSF 200μg/m²/d for 14 days. Course 2 (Risk-stratified): Based on the response to Course 1, patients receive HDA (for CR), DAC+HDA (for PR), or CLAG (for NR).
Locations (1)
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China