NCT07094464Active, not recruitingPhase 1
Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation
A Single-Arm, Open-Label Phase I Clinical Study of Selinexor Combined With Azacitidine for Maintenance Therapy in TP53 Mutant AML/MDS Patients Post-Transplant
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
This study aims to explore the safety and efficacy of selinexor combined with azacitidine for maintenance therapy in TP53 mutant AML/MDS patients following transplantation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Daihong Liu
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07094464
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From Jun 2025 to the primary completion date, Jun 2027
- 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 allergies or contraindications to the study drugs. (2) Pregnant or breastfeeding women. (3) Patients with uncontrolled active infections or active GVHD. (4) Patients with a long history of smoking or alcohol abuse affecting trial outcome evaluation.
- (5) Patients with psychiatric disorders or conditions preventing informed consent, unable to comply with treatment and assessment requirements.
- (6) Patients who underwent major surgery on important organs less than 6 weeks prior.
- (7) Abnormal liver function: ALT or AST \> 2.5 times the upper limit of normal; bilirubin \> 2 times the upper limit of normal; renal function: creatinine \> upper limit of normal.
- (8) Patients deemed unsuitable for this clinical trial by the investigator (e.g., poor compliance, substance abuse).
Who the study is looking for
- (1) Voluntary participation in the clinical study: Participant or legal guardian understands and signs the Informed Consent Form (ICF) and is willing to comply with all trial procedures.
- (2) Age below 75 years at screening; gender not restricted. (3) Diagnosed with AML or MDS with TP53 mutation (VAF ≥ 2%) and post-allo-HCT. (4) No severe allergic constitution. (5) Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.
- (6) Renal function: creatinine ≤ upper limit of normal. (7) No uncontrolled infections or severe psychiatric disorders. (8) ECOG performance score of 0-3; life expectancy of 4 months or more. (9) Peripheral blood counts for granulocytes and platelets.
Age in the registry: 14 years to 75 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.