Clinical Trials in China / NCT07779031
Active, not recruiting
Phase 1/2
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
NCT07779031 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acute Myeloid Leukaemia (AML)MDS (Myelodysplastic Syndrome)
Investigational drug(s) / intervention(s)
Azacitidine (AZA) Days 1 - 5: azacitidine 35mg/m2
Selinexor: selinexor 20mg q2w
Study summary
To explore the safety and efficacy of selinexor combined with azacitidine as post-transplant maintenance therapy for TP53-mutated AML/MDS.
Eligibility
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.).
Primary outcome measure(s)
- relapse free survival — 1 year
Relapse free survival (RFS) refers to the time from treatment to the first disease progression or death of the patient for any reason.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chinese PLA General Hospital | Beijing | China |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07779031 on ClinicalTrials.gov ↗ ← All trials in China