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Precision radiation may boost transplant success in tough leukemia cases

NCT ID NCT07532824

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a precise type of radiation called proton total marrow irradiation (TMI) given before a stem cell transplant for people with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The goal is to see if adding TMI to standard chemotherapy is safe and helps reduce side effects. Sixteen adults will receive the treatment and be followed for two years.

What this could mean

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

Active substance
Proton total marrow irradiation (a type of radiation therapy)
What this could lead to
If successful, this approach could make stem cell transplants safer and more effective for people with hard-to-treat blood cancers.
What could go wrong
This is an early-phase trial with only 16 participants, so results may not apply broadly. There are risks of side effects from radiation and transplant complications.

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 16 people

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

Started

Nov 2025

Expected to finish

Nov 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

18 to 65 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. Underlying diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), A) Acute Myeloid Leukemia (AML), meeting at least one of the following criteria: i. Relapsed disease after a prior complete remission (CR) or ii. Disease refractory to at least two cycles of intensive chemotherapy or iii. High-risk AML in complete remission (CR), defined by at least one of the following: iii a) Adverse molecular or cytogenetic risk according to ELN 2022 classification or iii b) Presence of measurable/minimal residual disease (MRD). B) Myelodysplastic Syndrome (MDS), meeting at least one of the following criteria: i. Relapsed MDS with increased blasts (MDS-IB) or ii. MDS-IB2 without reduction of bone marrow blasts below 10% after induction chemotherapy or after at least two cycles of azacitidine or iii. IPSS-M score \> 0.5 (high-risk or very high-risk disease). 2. Eligibility confirmed by the institutionalal Transplant Indication Committee according to standard criteria. 3. Age ≥ 18 years and ≤ 65 years 4. Ability to understand and voluntarily sign written informed consent Exclusion Criteria: Severe comorbidity, defined as the presence of one or more of the following conditions: 1. Left ventricular ejection fraction (LVEF) \< 40% 2. Creatinine clearance \< 0.5 mL/s 3. Total bilirubin \> 40 µmol/L (unless attributable to Gilbert's syndrome or hemolysis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN) 4. Pulmonary function impairment defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \< 50% of predicted value, or diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% of predicted value after correction for anemia 5. Karnofsky Performance Status \< 70% 6. Active viral hepatitis or human immunodeficiency virus (HIV) infection 7. Presence of liver cirrhosis 8. Pregnancy

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Hematology and Blood Transfusion

    RECRUITING

    Prague, 12800, Czechia

  • Proton Therapy Center Czech

    RECRUITING

    Prague, 18000, Czechia

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