[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-acute-myeloid-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,61,86,112,149,174,200],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":42,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100580604","phase-1-phase-12-cd45ra-depleted-stem-cell-addback-to-prevent-viral-or-fungal-infections-post-tcrabcd19-depleted-hsct-100580604",false,"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.","ALL","1 Month","25 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Leukemia","High Risk Acute Lymphoblastic Leukemia","High Risk Acute Myeloid Leukemia","Relapse 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",[43,44,45,46,47],"alpha beta T cell depletion","CD45RA","CD45RO","GVHD prevention","Memory T cells","RECRUITING","2026-04-13",{"date":51,"type":52},"2026-04-15","ACTUAL",{"date":54,"type":52},"2025-03-21",{"date":56,"type":21},"2032-03",{"name":58,"class":59},"Children's Hospital of Philadelphia","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":60},"100611180","clinical-study-to-evaluate-the-safety-and-efficacy-of--t-cells-for-the-prevention-of-relapse-after-allogeneic-transplantation-in-patients-with-high-risk-acute-myeloid-leukemia-100611180","NCT07237230","Clinical Study to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia","Clinical Study Protocol to Evaluate the Safety and Efficacy of γδ T Cells for the Prevention of Relapse After Allogeneic Transplantation in Patients With High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Voluntarily signs the informed consent form and is expected to be able to complete the follow-up examinations and treatments required by the study procedures.\n2. Age 18 to 65 years (inclusive), regardless of gender.\n3. Patients have one of the high-risk factors for relapse before allogeneic hematopoietic stem cell transplantation：①Meets the diagnostic criteria for relapsed or refractory disease as defined by the Chinese Guidelines for Diagnosis and Management of Relapsed\u002FRefractory Acute Myeloid Leukemia (2017 Edition);②Hyperleukocytosis (≥100×10⁹\u002FL) with concomitant central nervous system leukemia (CNSL); ③Positive minimal residual disease (MRD) before transplantation; ④Populations defined as having poor prognosis;⑤Myelodysplastic syndromes transformed to or secondary acute myeloid leukemia.\n4. Confirmed diagnosis of Acute Myeloid Leukemia(AML) and within 30±5 days after allogeneic transplantation.\n5. The subject has recovered from toxicities of previous therapies, defined as CTCAE grade \\\u003C2 (unless the abnormality is tumor-related or judged by the investigator to be stable with minimal impact on safety or efficacy).\n6. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-3 and an estimated life expectancy greater than 3 months.\n7. Adequate organ function is defined as:\n\n   1. Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);\n   2. Aspartate aminotransferase (AST) ≤3 × ULN;\n   3. Total bilirubin ≤1.5 × ULN;\n   4. Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL\u002Fmin;\n   5. Hemoglobin ≥50g\u002FL (must not have received transfusion support within 7 days prior to laboratory testing);\n   6. Room air oxygen saturation ≥92%;\n   7. Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography without pericardial effusion and no clinically significant ECG findings;\n   8. No clinically significant pleural effusion.\n\nExclusion Criteria:\n\n1. Diagnosis of another malignancy within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ after radical surgery;\n2. History of severe allergy (defined as a grade 2 or higher allergic reaction manifested by any of the following: airway obstruction \\[rhinorrhea, cough, wheezing, dyspnea\\], tachycardia, hypotension, arrhythmia, gastrointestinal symptoms \\[nausea, vomiting\\], incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest) or known allergy to any active ingredient, excipient, murine-derived products, or xenogeneic proteins contained in the investigational product;\n3. Severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, large-area myocardial infarction, New York Heart Association Class III or IV cardiac dysfunction, or refractory hypertension (defined as failure to achieve blood pressure control after \\>1 month of treatment with ≥3 tolerable antihypertensive drugs at optimal doses, including diuretics, or requiring ≥4 antihypertensive drugs for effective control);\n4. Severe respiratory disease (including history of or concurrent severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, or symptomatic bronchospasm);\n5. Presence of grade III-IV acute GVHD(Graft-Versus-Host Disease) or extensive chronic GVHD;\n6. Current use (or intention to use) other maintenance therapies post-hematopoietic stem cell transplantation that have been demonstrated to adversely affect the persistence of γδ T cells in vivo;\n7. Active neurological autoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome \\[GBS\\], amyotrophic lateral sclerosis \\[ALS\\]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]);\n8. Presence of severe psychiatric disorders;\n9. History of alcohol abuse or drug abuse;\n10. Clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]);\n11. Participation in another clinical study within 1 month prior to screening, unless deemed by the investigator as non-interfering with the safety and efficacy evaluation of the investigational product (e.g., non-interventional observational studies);\n12. Women who are pregnant or breastfeeding, female subjects planning pregnancy within 1 year after cell infusion, or male subjects with partners planning pregnancy within 1 year after cell infusion;\n13. Patients with contraindications to any study procedure or other medical conditions that may pose unacceptable risks, as determined by the investigator's judgment and\u002For clinical standards.","18 Years","65 Years",{"count":71,"type":21},40,[73],"NA","This is an investigator-initiated clinical trial evaluating the safety and efficacy of allogeneic γδ T cell infusion for relapse prevention in high-risk acute myeloid leukemia patients after transplantation.",[76],"High-Risk Acute Myeloid Leukemia","2025-11-14",{"date":79,"type":52},"2025-11-19",{"date":81,"type":52},"2025-07-01",{"date":83,"type":21},"2028-07-01",{"name":85,"class":59},"Donghua Zhang",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100552364","novel-digital-application-for-patients-with-acute-leukemia-100552364","NCT06472128","Novel Digital Application for Patients With Acute Leukemia","Multi-Site Randomized Controlled Trial of a Novel Digital Application (DREAMLAND) to Improve Outcomes for Patients With Acute Myeloid Leukemia","NAVIGATE","Inclusion Criteria:\n\n* Hospitalized patients (age \\> 18 years) with a diagnosis of AML.\n* Initiating treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen or b) hypomethylating agents (HMA) +\u002F- additional agents or modification of this regimen on a clinical trial.\n* Ability to comprehend and speak English as the digital apps are only available in English\n\nNote: Patients newly diagnosed as well as those with relapsed\u002Frefractory AML initiating treatment with intensive or HMA-based chemotherapy will be eligible to participate.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of acute promyelocytic leukemia\n* Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.","120 Years",{"count":96,"type":21},200,[73],"This research study is evaluating to examine the efficacy of a novel a self-administered digital application (DREAMLAND) for improving patients' long-term quality of life and psychological outcomes for patients with acute myeloid leukemia undergoing intensive chemotherapy.",[100,101,30],"Relapsed Adult Acute Myeloid Leukemia","Primary Refractory Acute Myeloid Leukemia","2025-11-06",{"date":104,"type":52},"2025-11-10",{"date":106,"type":52},"2024-10-21",{"date":108,"type":21},"2030-04-30",{"name":110,"class":59},"Massachusetts General Hospital",3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":60},"100607078","venetoclax-enhanced-bucy-vs-standard-bucy-conditioning-in-high-risk-aml-and-mds-patients-undergoing-allo-hsct-ven-bucy-study-100607078","NCT07183878","Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)","A Prospective, Multicenter, Randomized Controlled Study Comparing Venetoclax-Enhanced BUCY With Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Ven-BUCY","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to 2022 WHO classification\n* Age between 12 and 60 years\n* High-risk MDS as defined by at least one of the following:\n\n  * IPSS intermediate-2\u002Fhigh risk or IPSS-R intermediate\u002Fhigh\u002Fvery high risk\n  * TP53 mutation\n  * RAS pathway mutation (e.g., NRAS, KRAS, PTPN11, CBL, NF1, RIT1, FLT3, KIT)\n  * Therapy-related MDS\n* High-risk AML as defined by at least one of the following:\n\n  * TP53, RUNX1, or ASXL1 mutation\n  * t(6;9)(p23;q34.1)\u002FDEK-NUP214\n  * KMT2A rearrangement\n  * BCR-ABL1 fusion\n  * inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\n  * -5\u002Fdel(5q), -7, -17\u002Fabn(17p)\n  * Complex or monosomal karyotype\n  * FLT3-ITD high with wild-type NPM1\n  * Initial WBC ≥ 10×10\\^9\u002FL\n  * Secondary AML with history of MDS\u002FMPN or therapy-related AML\n  * AML with specific mutations (SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, STAG2)\n  * MRD positive before transplantation\n* For AML: must have achieved CR or CRi prior to transplantation; for MDS: bone marrow blasts \\\u003C 20%\n* Availability of a matched related or unrelated donor (10\u002F10 or 9\u002F10 HLA match)\n* ECOG performance status 0-2\n* Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault)\n* AST\u002FALT ≤ 3 × ULN and total bilirubin ≤ 2 × ULN\n* LVEF ≥ 50% by echocardiogram\n* Life expectancy \\> 8 weeks\n* Willingness to use effective contraception methods during and for a specified period after the study\n* Signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled cardiovascular disease or New York Heart Association class III\u002FIV heart failure\n* Other severe comorbid conditions that may interfere with study participation\n* Known HIV infection or uncontrolled active hepatitis B or C\n* Pregnant or breastfeeding women\n* More than one prior hematopoietic stem cell transplantation\n* Inability to understand the study protocol or provide informed consent\n* History of grade ≥ 3 non-hematologic adverse reaction to prior venetoclax therapy\n* Receipt of chemotherapy (except hydroxyurea\u002Fdexamethasone) or radiotherapy within 14 days before study treatment\n* Ongoing use of BCR-ABL1, IDH, or FLT3 inhibitors without proper washout (≥ 7 days)","12 Years","60 Years",{"count":123,"type":21},138,[73],"This is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy and safety of venetoclax-enhanced BUCY (Ven-BUCY) conditioning compared to the standard BUCY regimen in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants aged 12 to 60 years will be randomized 1:1 to receive either Ven-BUCY or standard BUCY conditioning. The primary endpoint is relapse-free survival (RFS) at two years post-transplant. Secondary outcomes include overall survival, relapse rate, non-relapse mortality, measurable residual disease (MRD), and treatment-related adverse events. The study aims to improve post-transplant outcomes by deepening disease remission through the addition of venetoclax, a BCL-2 inhibitor known to target leukemia stem cells and enhance chemotherapy sensitivity.",[127,76,128,129],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","High-Risk Myelodysplastic Syndromes",[131,132,133,134,135,136,137,138,139],"Venetoclax","BUCY conditioning","Allogeneic Hematopoietic Stem Cell Transplantation","Myeloablative Conditioning","Relapse-Free Survival","Graft-versus-Leukemia","GVHD","High-Risk AML","High-Risk MDS","2025-09-14",{"date":142,"type":52},"2025-09-19",{"date":144,"type":52},"2025-08-20",{"date":146,"type":21},"2028-08-20",{"name":148,"class":59},"First Affiliated Hospital of Zhejiang University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":16,"minAge":68,"maxAge":94,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100457489","specialty-compared-to-oncology-delivered-palliative-care-for-patients-with-acute-myeloid-leukemia-100457489","NCT05237258","Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia","SCOPE-L","Inclusion Criteria:\n\n* Patient Inclusion Criteria\n\n  * Hospitalized patients (age ≥ 18 years) with high-risk AML defined as:\n  * Patients with new diagnosis ≥ 60 years of age\n  * An antecedent hematologic disorder\n  * Therapy related-disease\n  * Relapsed or primary refractory AML\n  * Within five business days of initiating therapy with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or b) hypomethylating agents +\u002F- additional agents or modification of this regimen on a clinical trial.\n* Caregiver Inclusion Criteria\n\n  * Adult (≥18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week.\n\nExclusion Criteria:\n\n\\- Patient Exclusion Criteria\n\n* Patients with a diagnosis of acute promyelocytic leukemia (APML)\n* Patients with AML receiving supportive care alone\n* Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures\n* Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment\n* Patients expected to be discharged within 2 days",true,{"count":158,"type":21},2300,[73],"This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).",[162,101,30],"Relapsed Adult AML",[162,101,30,164],"Caregivers","2025-07-22",{"date":167,"type":52},"2025-07-25",{"date":169,"type":52},"2022-06-01",{"date":171,"type":21},"2029-04",{"name":110,"class":59},20,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":182,"enrollmentInfo":183,"targetDuration":185,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100568818","effect-of-donor-chose-on-the-outcomes-of-gvhd-prophylaxis-underwent-the-combined-treatment-of-atgptcy-for-haplo-hsct-100568818","NCT06686173","Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG\u002FPTCy for Haplo-HSCT","The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study","Donor chose","Inclusion Criteria:\n\n1\\. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:\n\n1. ELN prognostic stratification high-risk group (see Appendix for criteria)\n2. Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.\n\n2\\. Patients must have a suitable hematopoietic stem-cell donor.\n\n1. Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;\n2. Related donors had to be related donors matched 5\u002F10-7\u002F10 for HLA-A, -B, -C, -DQB1 and -DRB1 3. All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy\n\nExclusion Criteria:\n\n1. Intermediate-low risk AML patients (ELN criteria);\n2. Patients with extramedullary active lesions at the time of transplantation;\n3. Haploidentical collateral donors;\n4. Patients who refused allogeneic hematopoietic stem cell transplantation;","55 Years",{"count":184,"type":21},114,"1 Year","OBSERVATIONAL","This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation",[76,189],"Relapse And\u002For Refractory AML","NOT_YET_RECRUITING","2025-01-05",{"date":193,"type":52},"2025-01-07",{"date":195,"type":21},"2025-02-01",{"date":197,"type":21},"2028-02-01",{"name":199,"class":59},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":68,"maxAge":69,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":60},"100546367","phase-2-study-of-va-combined-with-haag-regimen-in-newly-diagnosed-intermediate-and-high-risk-aml-patients-100546367","NCT06394011","Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients","A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).\n2. Age 18-65.\n3. ECOG score: 0-2.\n4. No history of previous chemotherapy or target therapy.\n5. Serum total bilirubin \\\u003C= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \\\u003C= 1.5 times ULN, aspartate aminotransferase (AST) \\\u003C=1.5 times ULN;\n6. Creatinine clearance rate \\>=30 mL\u002Fmin;\n7. Serum lipase \\\u003C= 1.5 times ULN, amylase \\\u003C= 1.5 times ULN;\n8. Capable to understand and willing to participate in this study, signed the informed consent form.\n\nExclusion Criteria:\n\n1. AML transformed with chronic myelogenous leukemia.\n2. Acute promyelocytic leukemia (type M3).\n3. Patients with a second malignancy requiring treatment.\n4. Patients with uncontrolled active infection.\n5. Patients with left ventricular ejection fraction \\\u003C 0.5 by echocardiography or grade III\u002FIV cardiovascular dysfunction according to the New York Heart Association Classification.\n6. Patients with hepatic and renal inadequacy: total serum bilirubin \\>=2.0 mg\u002Fdl, AST \\>=3 times ULN, serum creatinine clearance (Ccr) \\\u003C50 ml \u002F min.\n7. Patients with arterial oxygen saturation (SpO 2) was \\\u003C95%.\n8. Patients with HIV infection.\n9. Patients with active hepatitis B or hepatitis C infection.\n10. Patients with other commodities that the investigators considered not suitable for the enrollment.",{"count":208,"type":21},60,[25],"The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.",[212,30],"Intermediate Risk Acute Myeloid Leukemia","2024-04-27",{"date":215,"type":52},"2024-05-01",{"date":217,"type":52},"2024-02-15",{"date":219,"type":21},"2026-12-30",{"name":221,"class":59},"The First Affiliated Hospital of Soochow University"]