Clinical trial · Interventional
A Single-Arm, Open Phase I Clinical Study of Selinexor in Combination With Azacitidine for the Treatment of High-Risk AML/MDS Patients After Allo-HSCT
NCT07779031CI-TRIAL-00123303TP53active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To explore the safety and efficacy of selinexor combined with azacitidine as post-transplant maintenance therapy for TP53-mutated AML/MDS.
Conditions
Conditions (2)
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 Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS (Myelodysplastic Syndrome) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) Days 1 - 5 | Drug | — | UNRESOLVED |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- azacitidine combined with selinexor
- description
- azacitidine 35mg/m2,d1-5, selinexor
- interventionNames
- Drug: Azacitidine (AZA) Days 1 - 5
- Drug: Selinexor
Primary outcomes (1)
- measure
- relapse free survival
- timeFrame
- 1 year
- description
- Relapse free survival (RFS) refers to the time from treatment to the first disease progression or death of the patient for any reason.
Secondary outcomes (3)
- measure
- overall survival (OS)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation in the clinical study: The subject or their legal guardian fully understands the study, provides informed consent by signing the Informed Consent Form (ICF), and is willing to comply with and complete all trial procedures. 2. Age \< 75 years at screening, regardless of gender. 3. Post-transplant MRD-negative acute myeloid leukemia / myelodysplastic syndrome with TP53 mutation. 4. No history of severe allergic constitution. 5. Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), and bilirubin ≤ 2 × ULN. 6. Renal function: Serum creatinine ≤ ULN. 7. No uncontrolled infection or severe psychiatric/psychological disorders. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, with an estimated life expectancy of ≥ 4 months. 9. Bone marrow flow cytometry confirming MRD negativity prior to enrollment. 10. Successful myeloid and platelet engraftment. 11. No active graft-versus-host disease (GVHD). Exclusion Criteria: * (1) Patients with known allergy or contraindications to the investigational drugs. (2) Pregnant or breastfeeding female patients. (3) Presence of uncontrolled active infection or active graft-versus-host disease (GVHD). (4) Patients with long-term smoking or heavy alcohol consumption that may interfere with the evaluation of trial results. (5) Patients with psychiatric disorders or other conditions that preclude obtaining informed consent, or who are unable to comply with treatment and examination procedures. (6) Patients who have undergone major organ surgery within less than 6 weeks prior to enrollment. (7) Abnormal liver function: ALT and AST \> 2.5 × upper limit of normal (ULN), or bilirubin \> 2 × ULN; abnormal renal function: serum creatinine \> ULN. (8) Patients deemed unsuitable for this clinical trial by the investigator (e.g., poor compliance, drug abuse, etc.).
References
Publications (0)
Data not yet available
No reference posted for this study.