Clinical trial · Interventional
Selinexor Combined With Induction Chemotherapy for Children With NUP98-positive AML
Clinical Study of Selinexor Combined With ZJCH-AML Induction Chemotherapy for the Treatment of NUP98-positive Pediatric Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| NUP98 Fusion-positive Acute Myeloid Leukemia | — | UNRESOLVED | — |
| Pediatric Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selinexor | Drug | Selinexor | ALIAS |
| ZJCH-AML Standardized Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor + ZJCH-AML
- description
- All enrolled patients receive Selinexor combined with the Zhejiang Children's Hospital (ZJCH) AML induction chemotherapy protocol.
- interventionNames
- Drug: Selinexor
- Drug: ZJCH-AML Standardized Chemotherapy
Primary outcomes (2)
- measure
- Complete Remission (CR) Rate
- timeFrame
- Day 14 of Induction Course 2 (approximately 2 months).
- description
- Percentage of patients achieving CR after Induction Course 1 or 2. CR is defined as bone marrow blasts \<5%, ANC \> 1\\times10\^9/L, and PLT \> 80\\times10\^9/L.
- measure
- Minimal Residual Disease (MRD) Negative Rate
- timeFrame
- Day 14 of Induction Course 1 (approximately 28 days).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with Acute Myeloid Leukemia (AML). * Confirmed NUP98 fusion gene positivity. * Pediatric patients. Exclusion Criteria: * Pediatric patients with AML who did not receive induction chemotherapy according to the Zhejiang Province pediatric AML protocol.
References
Publications (0)
Data not yet available