drugset / Trial / NCT07437170
Selinexor Combined With Induction Chemotherapy for Children With NUP98-positive AML
Phase 2
Active not recruiting
10 enrolled
The Children's Hospital of Zhejiang University School of Medicine
College of Pharmaceutical Sciences at Zhejiang University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 40 mg/m2 | Oral |
| Background | Cytarabine | Small molecule | 10 mg/m2 | — |
| Background | Homoharringtonine | Small molecule | 2 mg/m2 | — |