Precision radiation may boost transplant success in tough leukemia cases
NCT ID NCT07532824
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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. 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Institute of Hematology and Blood Transfusion
RECRUITINGPrague, 12800, Czechia
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Proton Therapy Center Czech
RECRUITINGPrague, 18000, Czechia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a liposomal drug combo improve AML treatment for older adults?
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Can a new drug trio overcome venetoclax resistance in leukemia?
- Can engineered cells beat relapsed blood cancers?