Actively Recruiting
Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML/MDS
Led by Institute of Hematology and Blood Transfusion, Czech Republic · Updated on 2026-04-16
16
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology and Blood Transfusion, Czech Republic
Lead Sponsor
P
Proton Therapy Center Czech s.r.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML/MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
- For AML: relapsed disease after prior remission, refractory to at least two intensive chemotherapy cycles, or high-risk in remission with adverse features
- For MDS: relapsed with increased blasts, MDS-IB2 with blasts not reduced below 10% after treatment, or high/very high-risk by IPSS-M score
- Eligibility confirmed by institutional Transplant Indication Committee
- Age between 18 and 65 years
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Severe comorbidities including:
- Left ventricular ejection fraction below 40%
- Creatinine clearance under 0.5 mL/s
- Total bilirubin over 40 µmol/L unless due to Gilbert's syndrome or hemolysis
- ALT or AST over five times upper limit of normal
- Pulmonary function with FEV1 and FVC under 50% predicted or DLCO under 50% after anemia correction
- Karnofsky Performance Status below 70%
- Active viral hepatitis or HIV infection
- Presence of liver cirrhosis
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Hematology and Blood Transfusion
Prague, Czechia, 12800
Actively Recruiting
2
Proton Therapy Center Czech
Prague, Czechia, 18000
Actively Recruiting
Research Team
V
Veronika Valkova, Assoc. Prof., MD, PhD
CONTACT
J
Jan Vydra, MD, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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