Proton total marrow irradiation before allogeneic transplant for high-risk AML or MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-center, non-randomized phase I/II pilot trial of proton-based total marrow irradiation (TMI) given as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. Participants receive either myeloablative or reduced-intensity chemotherapy chosen based on age and comorbidities, combined with proton TMI delivered as 12 Gy in three fractions. Graft-versus-host disease prophylaxis is given per institutional standards, with post-transplant cyclophosphamide preferred. Patients proceed to standard allo-HSCT and are followed for at least 24 months to monitor toxicity, relapse, and survival outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute of Hematology and Blood Transfusion
  Prague, Czechia Recruiting
• Proton Therapy Center Czech
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Veronika Valkova, Assoc. Prof., MD, PhD
• Email: Veronika.Valkova@uhkt.cz
• Phone: +420 221 977 301

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.