Selinexor Combined With Induction Chemotherapy for Children With NUP98-positive AML

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.

NCT Number	NCT07437170
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine Collaborators: College of Pharmaceutical Sciences at Zhejiang University
Conditions	Acute Myeloid Leukemia, Pediatric Acute Myeloid Leukemia, NUP98 Fusion-positive Acute Myeloid Leukemia
Enrollment	10 participants
Start Date	2024-01-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-27