[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-acute-myeloid-leukemia-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-acute-myeloid-leukemia-aml":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,84,107,129],{"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":24,"conditions":25,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100214912","phase-1-study-of-orally-administered-ag-120-in-subjects-with-advanced-hematologic-malignancies-with-an-idh1-mutation-100214912",false,"NCT02074839","Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation","A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation","Key Inclusion Criteria:\n\n* Subject must be ≥18 years of age.\n* Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation.\n* Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.\n* Subjects must have ECOG PS of 0 to 2.\n* Platelet count ≥20,000\u002FµL (Transfusions to achieve this level are allowed).\n* Subjects must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic disease\n* Subjects must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance \\>40mL\u002Fmin based on Cockroft-Gault glomerular filtration rate (GFR)\n* Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.\n* Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration.\n\nKey Exclusion Criteria:\n\n* Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and\u002For topical for ongoing skin GVHD is permitted.)\n* Subjects who received systemic anticancer therapy or radiotherapy \\\u003C14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).\n* Subjects who received an investigational agent \\\u003C14 days prior to their first day of study drug administration.\n* Subjects who are pregnant or breastfeeding.\n* Subjects with an active severe infection or with an unexplained fever \\>38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).\n* Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \\\u003C40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1.\n* Subjects with a history of myocardial infarction within the last 6 months of screening.\n* Subjects with a known unstable or uncontrolled angina pectoris.\n* Subjects with a known history of severe and\u002For uncontrolled ventricular arrhythmias.\n* Subjects with known unstable or uncontrolled angina pectoris.\n* Subjects with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events.\n* Patients taking medications that are known to prolong the QT interval\n* Subjects with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.\n* Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.\n* Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation.","ALL","18 Years",{"count":19,"type":20},291,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and\u002For the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.",[26,27,28,29],"Relapsed or Refractory Acute Myeloid Leukemia (AML)","Untreated AML","Other IDH1-mutated Positive Hematologic Malignancies","Myelodysplastic Syndromes",[31,32,33,34,35,36,27,37,38,39],"acute myeloid leukemia","AML","myelodysplastic syndrome","MDS","hematologic malignancies","IDH","IDH1","relapsed AML","refractory AML","RECRUITING","2026-06-11",{"date":43,"type":44},"2026-06-15","ACTUAL",{"date":46,"type":44},"2014-03-01",{"date":48,"type":20},"2026-12-31",{"name":50,"class":51},"Institut de Recherches Internationales Servier","OTHER",30,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100631444","a-single-arm-prospective-study-of-a-clad-labu-conditioning-regimen-in-hsct-for-rr-mdsaml-in-elderly-patients-100631444","NCT07500753","A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R\u002FR MDS\u002FAML in Elderly Patients","A Single-arm, Prospective Study of a Cladribine-Bridged Lisaftolax and Busulfan Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Myelodysplastic Syndromes and Acute Myeloid Leukemia in Elderly Patients","Inclusion Criteria:\n\n* Age ≥ 50years.\n* Meet the 2022 World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML),MDS, and be diagnosed with relapsed\u002Frefractory AML after treatment, fulfilling any of the following definitions:\n* Relapsed AML: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \\>5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemic cells after achieving complete remission (CR or CRi).\n* Refractory AML: Newly diagnosed cases that failed to respond after 2 courses of standard therapy; patients who relapsed within 12 months after consolidation therapy following CR; patients who relapsed after 12 months but failed to respond to conventional chemotherapy; patients with 2 or more relapses; persistent extramedullary leukemia.\n* MDS:Myelodysplastic Neoplasms (MDS)MDS are a group of clonal hematopoietic stem cell disorders characterized by: Dysplastic hematopoiesis (abnormal development of blood cells in the bone marrow); Cytopenias (one or more lineages of blood cells are reduced in number); Increased risk of transformation to acute myeloid leukemia (AML).Key diagnostic criteria (per WHO 2022 classification): Persistent cytopenia(s) for ≥4 months (unless specific genetic abnormalities are present); Morphological dysplasia in ≥10% of cells in one or more lineages; Presence of MDS-defining genetic abnormalities (e.g., SF3B1 mutation, isolated del(5q), TP53 biallelic alteration).\n* Cardiac, hepatic, and renal function test results within the following limits:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);Total bilirubin ≤ 3 × ULN;Serum creatinine ≤ 2 × ULN or creatinine clearance ≥ 40 mL\u002Fmin;Left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scan within the normal range (\\>50%).\n\n* Have a suitable allogeneic donor.\n* Expected survival ≥ 1 month.\n* Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* The patient understands the study protocol and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Patients had serious adverse reactions to investigational drugs such as allergies;\n* Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;\n* Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;\n* Patients received Class II or higher surgery within 4 weeks prior to enrollment;\n* Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;\n* Patient has active central nervous system leukemia infiltration;\n* Pregnant or lactating patients;\n* Patient is currently participating in another clinical studies;\n* Other conditions where the investigator deems the patient unsuitable for inclusion.","50 Years",{"count":52,"type":20},[63],"NA","Acute myeloid leukemia (AML) is one of the most common hematologic malignancies. With increasing life expectancy and the aging of society, the incidence of AML in the elderly population is rising. The prognosis of elderly AML patients is significantly worse than that of younger patients: the 5-year overall survival rate in patients over 60 years is less than 20%, while the median survival in patients over 80 years is only 3-6 months . Improving the overall prognosis of elderly AML has become a hot topic in current hematology research.\n\nHematopoietic stem cell transplantation (HSCT) is a therapeutic approach that involves intravenous infusion of hematopoietic stem cells with the goal of restoring bone marrow and immune function. Although several studies have focused on allo-HSCT in elderly patients, factors affecting transplant outcomes remain controversial, influencing clinical decision-making. Julian et al. retrospectively analyzed 103 elderly patients with relapsed\u002Frefractory AML who underwent allogeneic transplantation, showing that high-dose melphalan sequential chemotherapy was effective and well tolerated in elderly AML patients, with a 3-year overall survival rate exceeding 40%; disease prognosis was closely related to donor source and pre-transplant leukemic burden . Furthermore, studies on haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients are limited. A retrospective analysis from Peking University People's Hospital involving 199 elderly AML patients (≥50 years) who underwent allo-HSCT confirmed that haplo-HSCT is feasible in elderly AML patients; however, transplantation in a refractory\u002Factive disease state was associated with poorer transplant outcomes. A study from the EBMT summarized outcomes in 360 elderly patients (≥70 years) who underwent allogeneic transplantation in a non-remission state, reporting 2-year overall survival rates of 25.9%, 43%, and 62.4% for haplo-HSCT, unrelated donor, and matched sibling donor transplants, respectively.\n\nThe challenge in treating relapsed\u002Frefractory elderly AML patients lies in improving the tolerability of conditioning regimens and reducing conditioning-related toxicity, thereby increasing the success rate of transplantation. Venetoclax (VEN), an orally administered selective small-molecule B-cell lymphoma 2 (BCL-2) inhibitor, has demonstrated efficacy in randomized clinical trials across several hematologic malignancies. As monotherapy for relapsed\u002Frefractory AML, VEN shows modest efficacy while exhibiting good tolerability . In the global phase III clinical trial of venetoclax, in newly diagnosed AML patients unfit for intensive induction chemotherapy, venetoclax combined with azacitidine demonstrated significantly superior clinical efficacy compared to azacitidine alone, with a response rate (CR+CRi) more than three times higher than that of the control group, enabling patients to achieve faster and deeper remissions. Our center has also accumulated extensive experience with venetoclax in post-transplant maintenance therapy for AML and in the treatment of relapsed\u002Frefractory AML. Additionally, studies have confirmed the safety and efficacy of high-dose venetoclax in newly diagnosed AML . Based on the aforementioned clinical efficacy and theoretical rationale, our center previously conducted a study investigating the venetoclax + azacitidine + busulfan (VABu) regimen in allogeneic HSCT for elderly AML patients, confirming that this novel regimen reduces conditioning-related chemotherapy toxicity, improves tolerability, and demonstrates advantages in decreasing cardiotoxicity, mucositis, infections, and organ dysfunction. Lisaftolax, as a second-generation BCL-2 inhibitor, can partially overcome venetoclax resistance and improve patient outcomes.\n\nNevertheless, a consensus on the comprehensive systemic treatment strategy for elderly AML patients has not yet been reached globally. For high-risk or relapsed\u002Frefractory elderly AML patients, after risk stratification and assessment of response to chemotherapy, those who are suitable for allo-HSCT may receive a conditioning regimen consisting of cladribine bridged to lisaftolax and busulfan (Clad\u002FLABu), aiming to achieve longer remission duration, reduce post-transplant relapse rates, and improve long-term survival in elderly AML patients.",[26,66],"MDS (Myelodysplastic Syndrome)",[68,69,70,71,72,73],"Conditioning Regimen","Relapsed or Refractory Acute Myeloid Leukemia","Cladribine","Lisaftolax","Busulfan","Allogeneic Hematopoietic Stem Cell Transplantation","2026-04-12",{"date":76,"type":44},"2026-04-15",{"date":78,"type":20},"2026-04-01",{"date":80,"type":20},"2029-06-30",{"name":82,"class":51},"The First Affiliated Hospital of Soochow University",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100566837","phase-2-bcl2i-clag-m-in-rr-acute-myeloid-leukemia-100566837","NCT06660368","BCL2i CLAG-M in R\u002FR Acute Myeloid Leukemia","A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.\n* Adults aged ≥18 years - 80 years.\n* Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., \\\u003C5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.\n* Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \\> 3 months from venetoclax exposure), and\u002For 1 cycle of induction chemotherapy.\n* Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ function as defined within the protocol.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and have an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is not mandatory.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 4 months after completion of study drug administration.\n\nExclusion Criteria:\n\n* Venetoclax-refractory disease or recent venetoclax exposure \\\u003C 3 months prior to first dose of study therapy.\n* Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG\u002FFLAG\u002FMEC\u002FCLIA\u002FHAM, etc.).\n* Allogeneic stem cell transplant in the past 3 months.\n* Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.\n* Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility).\n* Active CNS involvement by AML.\n* WBC count ≥25k at the time study treatment begins.\n* Uncontrolled intercurrent systemic illness that would limit compliance.\n* Concurrent malignancy in addition to AML that requires active treatment with some exceptions.\n* Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg\u002Fday or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD).\n* Participants who have not recovered from adverse events (Aes) due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1), with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with active heart disease that limits the use of mitoxantrone or recent (\\\u003C6 months) history of an acute cardiovascular event (STEMI, NSTEMI).\n* Pregnant women are excluded from this study because venetoclax, cladribine, and cytarabine are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued.","80 Years",{"count":93,"type":20},52,[95],"PHASE2","This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.",[26],"2026-03-31",{"date":78,"type":44},{"date":101,"type":44},"2024-11-26",{"date":103,"type":20},"2027-11",{"name":105,"class":51},"H. Lee Moffitt Cancer Center and Research Institute",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":83},"100457783","phase-2-a-study-of-hyml-122-and-cytarabine-in-patients-with-flt3-positive-relapsed-or-refractory-acute-myeloid-leukemia-aml-100457783","NCT05241093","A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following: Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.\n* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* Combination of treatments and\u002For drugs required during the study period and cannot be discontinued that excluded from the protocol.\n* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g\u002Fd for men, ≥20g\u002Fd for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g\u002Fd. alcohol volume (g) conversion formula=alcohol consumption (mL)\\*alcohol content (%)\\*0.8.\n* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.\n* History of drug abuse or drug addicts.\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.",{"count":115,"type":20},18,[95],"This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.",[26],"2025-04-09",{"date":121,"type":44},"2025-04-10",{"date":123,"type":44},"2022-03-29",{"date":125,"type":20},"2026-06-30",{"name":127,"class":128},"Tarapeutics Science Inc.","INDUSTRY",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":83},"100457784","phase-2-a-study-of-hyml-122-in-patients-with-flt3-positive-relapsed-or-refractory-acute-myeloid-leukemia-aml-100457784","NCT05241106","A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:\n\nRefractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.\n\n* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* Combination of treatments and\u002For drugs required during the study period and cannot be discontinued that excluded from the protocol.\n* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g\u002Fd for men, ≥20g\u002Fd for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g\u002Fd. alcohol volume (g) conversion formula=alcohol consumption (mL)\\*alcohol content (%)\\*0.8.\n* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.\n* History of drug abuse or drug addicts.\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.",{"count":137,"type":20},15,[95],"this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.",[26],"2024-05-13",{"date":143,"type":44},"2024-05-14",{"date":145,"type":44},"2021-09-29",{"date":125,"type":20},{"name":127,"class":128}]