Can a drug duo keep High-Risk blood cancers at bay after transplant?
NCT ID NCT07779031
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This early-phase trial is exploring whether combining two drugs, selinexor and azacitidine, can help prevent relapse in people with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who carry a TP53 mutation and have already undergone a stem cell transplant. The study aims to assess the safety and effectiveness of this maintenance therapy, measuring how long participants remain free of disease progression. By testing this approach in a small group of patients, researchers hope to find a new way to improve long-term outcomes for this challenging patient population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- selinexor combined with azacitidine
- What this could lead to
- If successful, this combination could offer a new maintenance strategy to reduce relapse risk after stem cell transplant for high-risk AML/MDS with TP53 mutations.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and efficacy are not yet established. The combination may cause side effects or may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Chinese PLA General Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Chemotherapy at home for leukemia: a feasibility test
- Can a new pill boost the power of an existing leukemia treatment?
- Personalized dosing may improve stem cell transplant survival in blood cancer patients
- Could bone marrow from deceased donors cure blood cancers?
- New hope for AML patients: experimental drug IPN60340 enters key trial