[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633910":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Institute of Hematology and Blood Transfusion, Czech Republic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Proton TMI Conditioning Regimen","EXPERIMENTAL","Participants receive proton total marrow irradiation (TMI) added to a standard chemotherapy-based conditioning regimen prior to allogeneic hematopoietic stem cell transplantation.",[13],"Radiation: Proton Total Marrow Irradiation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Proton Total Marrow Irradiation","Proton total marrow irradiation (TMI) is administered as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. TMI is delivered to a total dose of 12 cobalt gray equivalents (CGE) in 3 fractions of 4 CGE once daily. In patients with extramedullary disease or central nervous system involvement, additional site-specific irradiation may be administered prior to TMI (10 CGE in 5 fractions), with a simultaneous integrated boost to involved sites during TMI (3 fractions of 3.5 CGE).\n\nTMI is combined with standard chemotherapy-based conditioning regimens, including a myeloablative regimen (fludarabine, busulfan, post-transplant cyclophosphamide) or a reduced-intensity regimen (fludarabine, melphalan, post-transplant cyclophosphamide), according to institutional standards.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Veronika Valkova, Assoc. Prof., MD, PhD","CONTACT","+420 221 977 301","Veronika.Valkova@uhkt.cz",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Jan Vydra, MD, PhD.","+420 221 977 290","Jan.Vydra@uhkt.cz",[32,52],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":20,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Institute of Hematology and Blood Transfusion","RECRUITING","Prague","12800","Czechia",{"type":39,"coordinates":40},"Point",[41,42],14.42076,50.08804,{"lat":42,"lon":41},[45,47,49],{"name":46,"role":24,"phone":29,"phoneExt":20,"email":30},"Jan Vydra, MD, PhD",{"name":48,"role":24,"phone":25,"phoneExt":20,"email":26},"Veronika Valkova, Assoc.Prof., MD, PhD",{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Veronika Valkova, Assoc.Prof., MD, PhD.","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":35,"state":20,"zip":54,"country":37,"countryCode":20,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Proton Therapy Center Czech","18000",{"type":39,"coordinates":56},[41,42],{"lat":42,"lon":41},[59],{"name":60,"role":24,"phone":20,"phoneExt":20,"email":61},"Katerina Dedeckova, MD, PhD","Katerina.Dedeckova@ptc.cz",{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[65],{"name":66,"class":67},"Proton Therapy Center Czech s.r.o.","UNKNOWN","100633910","phase-1-proton-based-total-marrow-irradiation-for-allogeneic-transplantation-in-high-risk-amlmds-100633910",false,"NCT07532824","Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML\u002FMDS","Proton Total Marrow Irradiation-Based Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation in High-Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome","UHKT-PTC-TMI-1","Inclusion Criteria:\n\n1. Underlying diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS),\n\n   A) Acute Myeloid Leukemia (AML), meeting at least one of the following criteria:\n\n   i. Relapsed disease after a prior complete remission (CR) or\n\n   ii. Disease refractory to at least two cycles of intensive chemotherapy or\n\n   iii. High-risk AML in complete remission (CR), defined by at least one of the following:\n\n   iii a) Adverse molecular or cytogenetic risk according to ELN 2022 classification or\n\n   iii b) Presence of measurable\u002Fminimal residual disease (MRD).\n\n   B) Myelodysplastic Syndrome (MDS), meeting at least one of the following criteria:\n\n   i. Relapsed MDS with increased blasts (MDS-IB) or\n\n   ii. MDS-IB2 without reduction of bone marrow blasts below 10% after induction chemotherapy or after at least two cycles of azacitidine or\n\n   iii. IPSS-M score \\> 0.5 (high-risk or very high-risk disease).\n2. Eligibility confirmed by the institutionalal Transplant Indication Committee according to standard criteria.\n3. Age ≥ 18 years and ≤ 65 years\n4. Ability to understand and voluntarily sign written informed consent\n\nExclusion Criteria:\n\nSevere comorbidity, defined as the presence of one or more of the following conditions:\n\n1. Left ventricular ejection fraction (LVEF) \\\u003C 40%\n2. Creatinine clearance \\\u003C 0.5 mL\u002Fs\n3. Total bilirubin \\> 40 µmol\u002FL (unless attributable to Gilbert's syndrome or hemolysis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN)\n4. Pulmonary function impairment defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \\\u003C 50% of predicted value, or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C 50% of predicted value after correction for anemia\n5. Karnofsky Performance Status \\\u003C 70%\n6. Active viral hepatitis or human immunodeficiency virus (HIV) infection\n7. Presence of liver cirrhosis\n8. Pregnancy","ALL","18 Years","65 Years",{"count":80,"type":81},16,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This is an open-label, single-center, non-randomized phase I\u002FII 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\u002Frefractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These patients have an unfavorable prognosis with standard conditioning approaches.\n\nParticipants 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.\n\nThe 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.",[88,89,90,91,92],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)\u002FAML","Proton Therapy","MDS and AML Prior to Allogeneic SCT","Myelodysplastic Neoplasm",[94,95,96,90,97,98,99],"High-Risk Hematologic Malignancy","Total Marrow Irradiation","TMI","Conditioning Regimen","Targeted Radiotherapy","HSCT","2026-04-09",{"date":102,"type":103},"2026-04-16","ACTUAL",{"date":105,"type":103},"2025-11-21",{"date":107,"type":81},"2029-11",{"name":5,"class":6},2]