Can a drug duo keep High-Risk blood cancers at bay after transplant?

NCT ID NCT07779031

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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