NCT07779031Active, not recruitingPhase 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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
To explore the safety and efficacy of selinexor combined with azacitidine as post-transplant maintenance therapy for TP53-mutated AML/MDS.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 21 Jun 2026
- Start date
- 1 May 2025
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Liping Dou
- NCT number
- NCT07779031
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 58
- From 1 May 2025 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- (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.).
Who the study is looking for
- 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.
- Age \< 75 years at screening, regardless of gender.
- Post-transplant MRD-negative acute myeloid leukemia / myelodysplastic syndrome with TP53 mutation.
- No history of severe allergic constitution.
- Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), and bilirubin ≤ 2 × ULN.
- Renal function: Serum creatinine ≤ ULN.
- No uncontrolled infection or severe psychiatric/psychological disorders.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, with an estimated life expectancy of ≥ 4 months.
- Bone marrow flow cytometry confirming MRD negativity prior to enrollment.
- Successful myeloid and platelet engraftment.
- No active graft-versus-host disease (GVHD).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.