[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,69,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100593485","phase-2-phase-ii-study-evaluating-the-efficacy-and-safety-of-the-combination-of-tagraxofusp-and-venetoclax-in-treatment-naive-blastic-plasmacytoid-dendritic-cell-neoplasm-patients-100593485",false,"NCT07007052","Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients","Open Label Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients","TAGVEN","Inclusion Criteria:\n\n1. Patients with a confirmed BPDCN diagnosis according to WHO 2022 revised criteria and have not received previous treatment : patients with skin or lymph node lesions but no bone marrow involvement can be included\n2. Age \\>18 years\n3. Ability to understand the protocol and to sign an informed consent\n4. Possibility of follow-up\n5. ECOG \\\u003C 3\n6. Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault formula.\n7. Adequate cardiac function defined by LVEF \\>\u002F= 50% by MUGA or ECHO and no clinically significant abnormalities on a 12-lead ECG\n8. Albumin level≥3,2g\u002FdL\n9. Adequate liver function as demonstrated by:\n\n   * aspartate aminotransferase (AST) ≤ 2.5 × ULN\\*\n   * alanine aminotransferase (ALT) ≤ 2.5 × ULN\\*\n   * bilirubin ≤ 3.0 × ULN, unless due to Gilbert's syndrome\\* \\* Unless considered due to leukemic organ involvement, in that cases values must be ≤ 10 × ULN\n10. Men, and women of childbearing potential must be using a highly effective method of contraception\n11. Negative urine\u002Fblood pregnancy test within 1 week prior to the initiation of treatment (if applicable)\n12. Patient covered by any social security system\n\nExclusion Criteria:\n\n1. Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.\n2. Previous treatment with venetoclax or tagraxofusp\n3. Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion\n4. Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg\u002Fday)\n5. Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients.\n6. Pregnant or breastfeeding woman\n7. Known positivity for hepatitis B or C infection except for those subjects with an undetectable viral load or subjects with serologic evidence of prior vaccination to HBV\n8. Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal)\n9. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his\u002Fher participating in this study including, but not limited to:\n\n   * Cardiovascular disease e.g., NYHA heart failure \\> class 2, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrythmias not controlled by medication.\n   * Renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.\n10. Subject with a history of other malignancies within the last three years prior to study entry, except for:\n\n    * Adequately treated in situ carcinoma of the breast or cervix uteri\n    * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\n    * Prostate cancer without needs for specific therapy\n    * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n11. Malabsorption syndrome or other conditions that preclude enteral route of administration\n12. Patient with hereditary fructose intolerance","ALL","18 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to study the efficacy of the tagraxofusp + venetoclax combination in treatment-naive blastic plasmacytoid dendritic cell neoplasm adult patients.\n\nThe main question is to verify the response in patients after 3 cycles of tagraxofusp+venetolax and to demonstrate if the combination of tagraxofusp + venetoclax increases the rate of complete remission, assessed after 3 months of treatment.\n\nPatients will receive a ramp-up phase of venetoclax during 3 days and at least 3 cycles of venetoclax. After, the investigators will evaluate the response, and depending on the response observed, patients may receive additional cycles of treatment for a maximum of 24 cycles, or receive an allograft or discontinue the treatment in the case of therapeutic failure.",[27],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[29,30,31,32,33],"blastic plasmacytoid dendritic cell neoplasm","Combination of venetoclax + tagraxofusp","Composite complete remission","Complete remission","Evaluation of response","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2025-12-11",{"date":42,"type":21},"2031-10-02",{"name":44,"class":45},"French Innovative Leukemia Organisation","OTHER",34,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100472368","blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-international-registry-100472368","NCT05430971","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry","Inclusion Criteria:\n\n* Diagnosis of BPDCN\n* Signed informed consent form for prospective patients\n\nExclusion Criteria:\n\n\\-",{"count":54,"type":21},200,"5 Years","OBSERVATIONAL","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.",[27],"2026-06-04",{"date":61,"type":38},"2026-06-05",{"date":63,"type":38},"2022-07-01",{"date":65,"type":21},"2032-07",{"name":67,"class":45},"Immune Oncology Research Institute",22,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"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":79,"type":21},18,[81],"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.",[84,85,86,27],"Leukemia, Myeloid, Acute(AML)","Precursor Cell Lymphoblastic Leukemia-Lymphoma","Myelodysplastic Syndromes (MDS)",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"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":106,"type":38},"2026-01-12",{"date":108,"type":38},"2024-10-23",{"date":110,"type":21},"2028-12-31",{"name":112,"class":45},"Institute of Hematology and Blood Transfusion, Czech Republic",1,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":113},"100516583","phase-1-safety-and-efficacy-of-cd123-targeted-car-nk-for-relapsedrefractory-acute-myeloid-leukemia-or-blastic-plasmacytoid-dendritic-cell-neoplasm-100516583","NCT06006403","Safety and Efficacy of CD123-targeted CAR-NK for Relapsed\u002FRefractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm","Clinical Study of Targeting CD123 Chimeric Antigen Receptor Natural Killer Cells (CAR-NK) in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm","Inclusion Criteria:\n\n1. Gender is not limited, age 18-75 years old (including the threshold value);\n2. The expression of CD123 in tumor cells was detected by flow cytometry.\n3. Patients with relapsed\u002Frefractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response (CR), the recurrence of leukemia cells in peripheral blood or bone marrow original cells ≥5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or the occurrence of extramedullary leukemia cell infiltration; b. Refractory: refers to those who have failed to receive 2 courses of treatment with standard protocols; Patients recurrence within 12 months after CR with consolidation and intensive treatment; Recurrence after 12 months but failed to respond to conventional chemotherapy; 2 or more relapses; Extramedullary leukemia persists;\n\n2\\) BPDCN: has failed to receive guidelines-recommended salvage therapy or is unable to tolerate current therapy, and has persistent or recurrent disease in any of the peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other site lesions.\n\n4\\. Expected survival time is more than 12 weeks;\n\n5\\. ECOG 0-2 points (Appendix 2);\n\n6\\. No serious mental disorders; The functions of important organs are basically normal:\n\n1. Cardiac function: echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;\n2. Renal function: serum creatinine ≤2.0×ULN;\n3. Liver function: ALT and AST ≤ 3.0×ULN;\n4. Total bilirubin and alkaline phosphatase ≤ 2.0×ULN (Gilbert syndrome ≤ 3.0×ULN);\n5. Blood oxygen saturation \\> 92%.\n\n   7\\. The patient or his\u002Fher guardian agrees to participate in the clinical trial and signs the ICF, indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Prior to screening, the following anti-tumor therapies were received: chemotherapy, targeted therapy, or other investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter), except in cases where disease progression has been confirmed after treatment;\n2. had a cerebrovascular accident or seizure within 6 months before signing the ICF;\n3. There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;\n4. suffering from any of the following heart diseases:\n\n   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;\n   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;\n   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);\n   4. History of severe non-ischemic cardiomyopathy;\n5. combined with active hepatitis B;\n6. Combined with active autoimmune diseases, long-term immunosuppressive therapy is required;\n7. have other malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n8. Had received live attenuated vaccine within 4 weeks prior to screening;\n9. Women who are pregnant or breastfeeding, and male or female subjects who plan to have a family within 1 year after receiving CAR T cell transfusion;\n10. Circumstances deemed unsuitable for participation in the study by other researchers.","75 Years",{"count":123,"type":21},36,[125,24],"PHASE1","This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed\u002Frefractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed\u002Frefractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.",[128,27,129,130],"Acute Myeloid Leukemia","Relapse Leukemia","Refractory Leukemia","2023-08-28",{"date":133,"type":38},"2023-08-30",{"date":135,"type":21},"2023-08-31",{"date":137,"type":21},"2026-08-31",{"name":139,"class":140},"Chongqing Precision Biotech Co., Ltd","INDUSTRY"]