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Half-Matched stem cell transplants tested as a cure path for older aplastic anemia patients

NCT ID NCT07819812

Cure Sponsor: Peking University People's Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing a conditioning regimen built around thiotepa before a haploidentical, or half-matched, stem cell transplant in people aged 50 and older with severe aplastic anemia. The regimen also includes busulfan, fludarabine, anti-thymocyte globulin, and basiliximab, given in the days before transplant. The study tracks one-year transplant-related mortality as its main measure, along with how quickly new neutrophils and platelets appear. Ten participants will receive the treatment at a single center.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A conditioning regimen combining thiotepa, busulfan, fludarabine, anti-thymocyte globulin, and basiliximab given before a haploidentical stem cell transplant
What this could lead to
If it works, this could give older adults with severe aplastic anemia a safer path to a curative donor stem cell transplant, even when no fully matched donor is available.
What could go wrong
The study is small and single-center, so results may not hold up in larger or more varied groups. Conditioning before transplant carries real risks, including infection, organ toxicity, and graft-versus-host disease.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

50 years and older

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. Age 50 years or older. 2. Diagnosis of severe aplastic anemia or very severe aplastic anemia according to institutional diagnostic criteria. 3. Planned to undergo haploidentical hematopoietic stem cell transplantation with an eligible haploidentical donor. 4. Meets institutional performance status and cardiac, hepatic, renal, and pulmonary function requirements for transplantation. 5. Provides written informed consent. Exclusion Criteria: 1. Previous allogeneic hematopoietic stem cell transplantation. 2. Uncontrolled active infection at the time of enrollment or transplantation. 3. Known hypersensitivity to busulfan, fludarabine, thiotepa, basiliximab, or any relevant excipient. 4. Concurrent hematologic malignancy or another condition that, in the investigator's judgment, makes transplantation unsafe. 5. Pregnancy or breastfeeding. 6. Any serious uncontrolled medical, psychiatric, or social condition that could compromise protocol compliance or participant safety. \-

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Conditions

The condition(s) this trial relates to.

acquired aplastic anemia aplastic anemia idiopathic aplastic anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aplastic anaemia Hematopoietic cell transplant Severe aplastic anemia

How to take part

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  1. The official record

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