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| Name | Class |
|---|---|
| College of Pharmaceutical Sciences at Zhejiang University | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor + ZJCH-AML | Experimental | All enrolled patients receive Selinexor combined with the Zhejiang Children's Hospital (ZJCH) AML induction chemotherapy protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | Induction Course 1: 40mg/m² orally on Days 1, 3, 8, and 10. Induction Course 2: 40mg/m² orally on Days 1 and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate | 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. | Day 14 of Induction Course 2 (approximately 2 months). |
| Minimal Residual Disease (MRD) Negative Rate | The proportion of patients reaching MRD negativity (threshold < 0.1%) measured by flow cytometry or molecular methods. | Day 14 of Induction Course 1 (approximately 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from the date of enrollment to death from any cause. | 1 year. |
| Event-Free Survival (EFS) | The time from the date of enrollment to events including treatment failure, relapse, or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| ZJCH-AML Standardized Chemotherapy | Drug | 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). |
|
| 1 year. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C585161 | selinexor |
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