NCT07532824 Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML/MDS
| NCT ID | NCT07532824 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institute of Hematology and Blood Transfusion, Czech Republic |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-11-21 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, single-center, non-randomized phase I/II pilot study evaluating proton-based Total Marrow Irradiation (TMI) as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult patients with high-risk or relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These patients have an unfavorable prognosis with standard conditioning approaches. Participants will receive a standard conditioning regimen consisting of either myeloablative or reduced-intensity chemotherapy, selected according to age and comorbidities, combined with proton TMI delivered at a total dose of 12 Gy in three fractions. Graft-versus-host disease (GvHD) prophylaxis will be administered according to institutional standards, preferentially using post-transplant cyclophosphamide. Patients will subsequently undergo standard allo-HSCT and will be followed for at least 24 months after transplantation. The primary objective of the study is to assess the safety and tolerability of proton TMI added to standard conditioning, as measured by non-relapse mortality and treatment-related toxicity within the first 100 days after transplantation. Secondary objectives include evaluation of engraftment kinetics, incidence of relapse, overall and relapse-free survival, GvHD outcomes, and quality of life. Study outcomes will be analyzed descriptively and compared with a matched historical cohort.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07532824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07532824 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07532824 currently recruiting?
Yes, NCT07532824 is actively recruiting participants. Contact the research team at Veronika.Valkova@uhkt.cz for enrollment information.
Where is the NCT07532824 trial being conducted?
This trial is being conducted at Prague, Czechia, Prague, Czechia.
Who is sponsoring the NCT07532824 clinical trial?
NCT07532824 is sponsored by Institute of Hematology and Blood Transfusion, Czech Republic. The trial plans to enroll 16 participants.
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