[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapse-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapse-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,50,92,139,163,193],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":49},"100620325","phase-1-a-study-of-revumenib-and-mezigdomide-in-people-with-leukemia-100620325",false,"NCT07356154","A Study of Revumenib and Mezigdomide in People With Leukemia","A Phase 1\u002F2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed\u002FRefractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias","Inclusion Criteria:\n\n* Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Participant has relapsed\u002Frefractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)\n* Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation.\n\n  1. At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK sites, NPM1 testing may be performed in local CLIA-certified laboratories using validated clinical assays with capable of detecting NPM1c variants at a frequency of ≥5%. Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.\n  2. At MSK, KMT2A and NUP98 testing will utilize chromosomal analysis and fluorescence in situ hybridization studies. At non-MSK sites, testing may be performed in local CLIA-certified laboratories using validated clinical assays with performance characteristics sufficient to detect relevant translocations. Eligible patients must have a KMT2A or NUP98 translocation as determined by these assays\n  3. The patient's chart will be utilized for screening purposes\n* Regarding prior treatment with a menin inhibitor:\n\n  1. Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor\n  2. Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve (no previous treatment with a menin inhibitor)\n  3. Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received a menin inhibitor)\n* Regarding prior alloSCT, at 60 days must have elapsed from day of transplant and at least 4 weeks must have elapsed from first dose of donor lymphocyte infusion.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \\\u003C18 years); Lansky Performance Score of ≥50 (if aged \\\u003C16 years).\n* Participant must have a WBC count \\\u003C25,000\u002FμL at the time of initiation of study drug (leukapheresis may be performed and\u002For hydroxyurea may be administered to decrease the WBC count to \\\u003C25,000\u002FμL).\n* Participant has adequate organ function defined as:\n\n  1. Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  2. Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  3. Serum creatinine \\\u003C 2 x ULN or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  4. Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram or multigated acquisition scan.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Participants who have previously received mezigdomide.\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g., family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participant with active use of strong or moderate CYP3A4 inhibitors or strong CYP3A4 inducers. Details reviewed in Appendix B.\n* Participant with use of proton pump inhibitors less than 2 weeks prior to initiating treatment\n* Female participant who is pregnant or lactating. Male or female participants not willing to comply with contraceptive requirements, which include 4 months of contraception after last dose of revumenib for males and 6 months for females. Additional contraception details reviewed in Appendix D.","ALL","12 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.",[27,28,29,30,31,32,33,34],"Leukemia","Acute Leukemia","Relapse Leukemia","Refractory Leukemia","Refractory Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia",[27,28,29,30,31,32,33,34,36,37],"Memorial Sloan Kettering Cancer Center","25-229","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2026-01-16",{"date":46,"type":20},"2029-01-16",{"name":36,"class":48},"OTHER",10,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":76,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100580604","phase-1-phase-12-cd45ra-depleted-stem-cell-addback-to-prevent-viral-or-fungal-infections-post-tcrabcd19-depleted-hsct-100580604","NCT06839456","Phase 1\u002F2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab\u002FCD19 Depleted HSCT","Phase 1\u002F2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Disease for which allogeneic HSCT may be curative.\n2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).\n3. Patients must be 25 years of age and less\n4. Evaluation for organ and infectious status as per our CTTS standard operating procedure.\n5. Signed consent by parent\u002Fguardian or able to give consent if 18 years of age and older.\n6. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP.\n\nExclusion Criteria:\n\n1. Patients who have performance score less than 60.\n2. No suitable donor available for mobilized peripheral stem cells.\n3. Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.\n4. Planned receipt of alemtuzumab during conditioning.\n5. Patients with an available 10\u002F10 HLA matched sibling donor.\n6. Patients who do not meet institutional disease, organ or infectious criteria.\n\nDonor selection and eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation.\n2. Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells.\n3. HLA testing\u002Fmatching\n\n   * HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1\n   * Related donor: Must be ≥ 5\u002F10 match\n   * Unrelated donor: 10\u002F10 or 9\u002F10 match\n   * KIR typing for haploidentical donor for hematologic malignancies\n   * Donor specific HLA antibodies (DSA) should be assessed for all subjects receiving an HLA mismatched graft (≤ 9\u002F10).\n4. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection\n5. Donors must be willing to sign consent to participate in this study.","1 Month","25 Years",{"count":60,"type":20},100,[23,24],"The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab\u002FCD19 depleted PSCT.",[27,64,65,29,66,67,68,69,70,71,72,73,74,75],"High Risk Acute Lymphoblastic Leukemia","High Risk Acute Myeloid Leukemia","MDS (Myelodysplastic Syndrome)","Relapsed Non-Hodgkin Lymphoma","Acquired Aplastic Anemia","Inherited BMF Syndrome","Immunodeficiency","Primary Immune Regulatory Disorder","Hemoglobinopathies","Bone Marrow Failure","Inborn Errors of Metabolism","HLH",[77,78,79,80,81],"alpha beta T cell depletion","CD45RA","CD45RO","GVHD prevention","Memory T cells","2026-04-13",{"date":84,"type":42},"2026-04-15",{"date":86,"type":42},"2025-03-21",{"date":88,"type":20},"2032-03",{"name":90,"class":48},"Children's Hospital of Philadelphia",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":114,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100478607","pharmacogenomic-association-study-in-indian-children-with-acute-lymphoblastic-leukemia-100478607","NCT05512169","Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia","Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)","MPGx-INDALL","Inclusion Criteria:\n\n* Age \\> 1 year old and ≤18 years old at enrolment\n* Previously untreated\n* ALL diagnosis confirmed by morphology and flow-cytometry\n* Indian origins\n* Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol\n* Written Informed consent to participate in the study has to be signed by the participant\u002Fparent\u002Fguardian\n\nExclusion Criteria:\n\n* Previously tretaed patients\n* Patients with Down's syndrome\n* Patients with mature B-ALL","1 Year","18 Years",{"count":103,"type":20},556,"OBSERVATIONAL","A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva.\n\nThe study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.",[107,108,109,110,29,111,112,113],"ALL, Childhood","Pediatric Cancer","Toxicity, Drug","Adverse Drug Event","Drug Toxicity","Drug Effect","Drug Interaction",[115,116,117,118,119,120,121,122,123,124,125,126,127,128],"Pharmacogenetics","Pharmacogenomics","Genetic polymorphism","Sequencing","Genotyping","Indian","Pediatrics","SNP","gene variant","germline genetic variant","somatic variant","biomarker","steroid response","genetic predisposition","2026-01-13",{"date":131,"type":42},"2026-01-15",{"date":133,"type":42},"2022-12-01",{"date":135,"type":20},"2027-03-30",{"name":137,"class":48},"University of Geneva, Switzerland",2,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":91},"100599939","phase-2-efficacy-and-safety-of-vah-as-a-bridging-regimen-to-allo-hct-in-relapsedrefractory-aml-100599939","NCT07091006","Efficacy and Safety of VAH as a Bridging Regimen to Allo-HCT in Relapsed\u002FRefractory AML","A Prospective Study on the Efficacy and Safety of Venetoclax, Azacitidine, and Homoharringtonine (VAH) Combination as a Bridging Regimen to Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Aged 14 to 70 years (inclusive), regardless of gender;\n* The diagnosis of AML was confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;\n* Relapsed AML: After achieving complete remission (CR), the reappearance of leukemic cells in peripheral blood, or ≥5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration by leukemic cells.\n\nRefractory AML: Newly diagnosed cases that are unresponsive after two courses of standard induction therapy; patients who relapse within 12 months after consolidation\u002Fintensification therapy post-CR; patients who relapse after 12 months but fail to respond to conventional chemotherapy; patients with two or more relapses; or those with persistent extramedullary leukemia.\n\n* With RUNX1::RUNX1T1 AML: Positive measurable residual disease (MRD) on bone marrow flow evaluation after the second consolidation therapy and\u002For less than a 3-log decrease in the RUNX1::RUNX1T1 fusion gene and diagnostic baseline values;\n* ECOG score ≤2; HCT-CI score \\\u003C3; Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN); Alanine aminotransferase (ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;\n* Left ventricular ejection fraction (LVEF) ≥50%;\n\nExclusion Criteria:\n\n* Allergies or contraindications to any of the drugs in the protocol;\n* Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;\n* Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);\n* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;\n* Patients with neurological or psychiatric disorders;\n* The patient is pregnant or breastfeeding;\n* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.\n* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;","14 Years","70 Years",{"count":149,"type":20},44,[24],"Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed\u002Frefractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed\u002Frefractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed\u002Frefractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed\u002Frefractory AML.",[29],"NOT_YET_RECRUITING","2025-07-28",{"date":156,"type":42},"2025-07-29",{"date":158,"type":20},"2025-08-01",{"date":160,"type":20},"2028-05-01",{"name":162,"class":48},"Ruijin Hospital",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100545738","efficacy-and-safety-of-mtbf-conditioning-regimen-for-salvageable-allo-hsct-in-the-treatment-of-rr-aml-100545738","NCT06385808","Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R\u002FR AML","Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;\n* Age 18-65 years old (including upper and lower limits);\n* No gender limitation\n* Relapsed or refractory (R\u002FR) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.\n* R\u002FR AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells \\>0.050 or the occurrence of extramedullary leukemia cell infiltration after CR.\n* Could tolerate allogeneic hematopoietic stem cell transplantation.\n\nExclusion Criteria:\n\n* Hypersensitivity to any investigational drug or its components;\n* Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)\n* Cardiac function and disease meet one of the following conditions:\n\n  1. Long QTc syndrome or QTc interval\\>480 ms;\n  2. Complete left bundle branch block, II or III degree atrioventricular block;\n  3. Serious and uncontrolled arrhythmia requiring drug treatment;\n  4. American New York Heart Association rating ≥ III degree;\n  5. Cardiac ejection fraction (LVEF) is less than 60%;\n  6. History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system;\n* Active infection of hepatitis B and hepatitis C;\n* Human immunodeficiency virus (HIV) infection;\n* Patients with other malignant tumors;\n* History of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.);\n* History of mental illness or cognitive impairment;\n* Other investigators determined that participation in this study was not appropriate.","65 Years",{"count":172,"type":20},37,[174],"NA","The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.",[29,177,178,179],"Refractory Acute Myeloid Leukemia","Conditioning","Hematopoietic Stem Cell Transplantation",[181,182,183],"relapsed or refractory acute myeloid leukemia","conditioning regimen","allogeneic hematopoietic stem cell transplantation","2024-04-25",{"date":186,"type":42},"2024-04-26",{"date":188,"type":20},"2024-05-01",{"date":190,"type":20},"2026-12-31",{"name":192,"class":48},"First Affiliated Hospital Xi'an Jiaotong University",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":101,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":91},"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":202,"type":20},36,[23,24],"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.",[32,206,29,30],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","2023-08-28",{"date":209,"type":42},"2023-08-30",{"date":211,"type":20},"2023-08-31",{"date":213,"type":20},"2026-08-31",{"name":215,"class":216},"Chongqing Precision Biotech Co., Ltd","INDUSTRY"]