Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation

Plain-language summary

This study evaluates maintenance therapy with Selinexor and Azacitidine in patients with TP53-mutant acute myeloid leukemia or myelodysplastic syndrome after stem cell transplantation. It is open to patients under 75 who have had an allogeneic transplant and a confirmed TP53 mutation. The study is being conducted in Phase 1; it is not currently recruiting but remains ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Daihong Liu

Intervention

Maintenance Therapy with Selinexor and Azacitidine

Start date

6/1/2025

Estimated completion

12/30/2028

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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).