[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institute of Hematology and Blood Transfusion, Czech Republic\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29,30,31,32,33],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)\u002FAML","Proton Therapy","MDS and AML Prior to Allogeneic SCT","Myelodysplastic Neoplasm",[35,36,37,31,38,39,40],"High-Risk Hematologic Malignancy","Total Marrow Irradiation","TMI","Conditioning Regimen","Targeted Radiotherapy","HSCT","RECRUITING","2026-04-09",{"date":44,"type":45},"2026-04-16","ACTUAL",{"date":47,"type":45},"2025-11-21",{"date":49,"type":22},"2029-11",{"name":51,"class":52},"Institute of Hematology and Blood Transfusion, Czech Republic","OTHER",2,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100574945","early-phase-1-cart123-t-cells-in-relapsed-or-refractory-cd123-hematologic-malignancies-a-dose-escalation-phase-i-trial-100574945","NCT06765876","CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial","Safety and Efficacy of Anti-CD123 Chimeric Antigen Receptor-Modified Autologous T Cells (CART123) in Patients With Relapsed\u002FRefractory CD123+ Hematologic Malignancies: A Dose Escalation, Open-Label, Phase I Study","UHKT-CAR123-01","Inclusion Criteria:\n\n1. Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below:\n\n   a) Patients with AML will be eligible if they meet one of the following criteria:\n\n   i) Patient with refractory AML defined as failure to achieve CR or CRi after at least 2 cycles of induction chemotherapy or 1 cycle of high dose salvage regimen or 4 cycles of venetoclax with azacytidine OR\n\n   ii) Second or subsequent relapse of AML OR\n\n   iii) Relapse after allogeneic HSCT.\n\n   b) Patients with ALL will be eligible if they meet one of following criteria:\n\n   i) disease refractory to or relapsed after CAR-19 cell therapy OR\n\n   ii) CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin.\n\n   c) Patients with BPDCN will be eligible if they meet following criteria:\n\n   i) Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation.\n\n   d) Patients with MDS-IB2 will be eligible if they meet one of following criteria:\n\n   i) Disease refractory to at least four cycles of azacytidine or progression on azacytidine-based therapy OR\n\n   ii) Disease refractory to induction chemotherapy OR\n\n   iii) Relapse after haematopoietic stem cell transplantation.\n2. CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age between 18 and 70 years.\n4. Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.\n5. Patient able to understand and sign informed consent.\n6. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n7. Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP.\n2. Allogeneic HSCT within 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 8 weeks.\n5. Respiratory insufficiency (need for oxygen therapy).\n6. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4 times normal upper limit.\n7. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n8. Heart failure with LVEF \\\u003C 50% by echocardiography.\n9. Presence of active grade 3 - 4 acute GvHD or severe chronic GvHD.\n10. Serious uncontrolled neurological comorbidity.\n11. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n12. Women: pregnancy or breast-feeding.\n13. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    1. female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    2. male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.","70 Years",{"count":64,"type":22},18,[66],"EARLY_PHASE1","Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.",[69,70,71,72],"Leukemia, Myeloid, Acute(AML)","Precursor Cell Lymphoblastic Leukemia-Lymphoma","Myelodysplastic Syndromes (MDS)","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"CAR123 T lymphocytes","CART123","CD123+ Hematologic Malignancies","Anti-CD123","Chimeric Antigen Receptor (CAR) T Cells","Autologous T Cells","Hematopoietic Malignancies","Immunotherapy","Personalized Medicine","Biological Therapy","Phase I Clinical Trial","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Relapsed Myelodysplastic syndrome","Relapsed Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Myeloid Leukaemia Recurrent","2026-01-08",{"date":92,"type":45},"2026-01-12",{"date":94,"type":45},"2024-10-23",{"date":96,"type":22},"2028-12-31",{"name":51,"class":52},1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":98},"100443427","phase-1-cart19-cells-effects-in-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-and-non-hodgkins-lymphoma-100443427","NCT05054257","CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma","Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed\u002Frefractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.","UHKT-CAR19-01","Inclusion Criteria:\n\n1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:\n\n   1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR\n   2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR\n   3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).\n2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age ≥18 years and ≤ 80 yearss.\n4. Patient able to understand and sign informed consent.\n5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n\nGeneral Exclusion Criteria:\n\n1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).\n2. Autologous or allogeneic HCT in 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 6 weeks.\n5. Parenchymal central nervous system involvement.\n6. Respiratory insufficiency (need for oxygen therapy).\n7. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4times normal upper limit.\n8. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n9. Heart failure with EF \\\u003C 30% by echocardiography.\n10. Presence of active grade 3-4 acute GvHD.\n11. Serious uncontrolled neurological comorbidity.\n12. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n13. Women: pregnancy or breast-feeding.\n14. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    * female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    * male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.\n\nExclusion criteria to Procurement of IMP manufacture starting material\n\n1. Severe uncontrolled active infection.\n2. Positive test results for HIV1\u002F2, Hepatitis B\u002FC and lues.\n3. Concurrent or recent prior therapies before apheresis:\n\n   * Autologous or allogeneic hematopoietic cell transplantation within 12 weeks.\n   * Clofarabine, Fludarabine, Alemtuzumab within 8 weeks.\n   * Donor lymphocyte infusions within 4 weeks.\n   * Pegylated asparaginase within 4 weeks.\n   * Maintenance chemotherapy within 2 weeks.\n   * Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks.\n   * Vincristine within 2 weeks.\n   * Intrathecal methotrexate within 1 week.\n   * Granulocyte Colony Stimulating Factor (G-CSF) within 5 days.\n   * Therapeutic dose of corticosteroids within 3 days.\n   * Short-acting cytostatics within 3 days\n\nExclusion criteria to IMP administration\n\n1. Severe, uncontrolled active infections.\n2. Life expectancy \\\u003C 6 weeks.\n3. Parenchymal central nervous system involvement\n4. Respiratory insufficiency (need for oxygen therapy).\n5. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 4times normal upper limit.\n6. Acute kidney injury with serum creatinine \\> 180 µg\u002FL, oliguria or need for acute dialysis.\n7. Heart failure with Ejection Fraction (EF) \\\u003C 30% by echocardiography.\n8. Presence of active grade 3 - 4 acute GvHD\n9. Serious uncontrolled neurological comorbidity.","80 Years",{"count":109,"type":22},10,[25],"Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed \u002F Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.",[113,114,115],"Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia","Non-Hodgkin's Lymphoma Refractory","Non-Hodgkin's Lymphoma, Relapsed",[117,17,118,119,120,121,122,123],"B Cell","Relapsed or Refractory","B-NHL","Leukemia","Chimeric antigen receptor","CAR","CAR T cell","2025-01-03",{"date":126,"type":45},"2025-01-06",{"date":128,"type":45},"2021-06-02",{"date":130,"type":22},"2025-12-12",{"name":51,"class":52},""]