[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-acute-myeloid-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,73,102,133,157,182],{"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":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100517416","phase-1-a-study-of-cd371-ysnvzil-18-car-t-cells-in-people-with-acute-myeloid-leukemia-100517416",false,"NCT06017258","A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia","Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (CLEAR-AML)","Inclusion Criteria:\n\nSubject Inclusion: Collection of T cells (Part A)\n\n* History of CD371+ AML\n\n  * Any disease status is eligible for collection\n  * Expression of CD371 at any level on AML blasts (any method of detection including IHC and\u002For flow cytometry)\n* Age\u002FWeight\n\n  * Pediatrics: ≥ 1 year and ≥ 10kg for collection\n  * Adults: no limit on age\u002Fweight for collection\n* Patients with history of allo-HCT are eligible for collection if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable)\n\nSubject Inclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Relapsed\u002FRefractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and\u002For advanced disease:\n\n  o Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:\n* Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as \"7+3,\" MEC, HiDAC, FLAG+idarubicin, etc.);\n* Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;\n* Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy\n\n  * Early first relapse: Patients are eligible from disease perspective in the event of first morphologic relapse or new extramedullary disease less than 12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy\n  * Late first relapse: Patients with first morphologic relapse or new extramedullary disease ≥12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy may respond to intensive re-induction using the initial induction regimen and not eligible from a disease perspective unless the treating investigator feels the patient is unlikely to benefit from repeating the initial induction regimen (for example, relapse occurring 12 months into CR on continuous azacitidine\u002Fvenetoclax therapy), in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient.\n  * Advanced disease: Patients are eligible from disease perspective in the event of relapsed AML refractory to reinduction therapy, relapse following alloHCT, or second or later relapse.\n  * Disease eligibility considerations for all patients: Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD\u002FTKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria:\n* Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient Age: any age is eligible for treatment if eligible for collection\n\n  o The first 3 patients in the first dose cohort must be ≥ 16 years of age, while the first 2 patients in subsequent cohorts must be ≥ 16 years of age (see Section 10.4)\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60\n  * Age \\\u003C 16 years: Lansky ≥ 60\n* Patients with history of allo-HCT are eligible for treatment if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any systemic immunosuppressive agents for 30 days prior to treatment (physiologic dose of corticosteroids is acceptable)\n  * Treating physician considers the patient to be a candidate for second alloHCT\n* Identification of a suitable donor\u002Fsource for alloHCT as determined by the treating physician.\n* Adequate organ function is required, defined as follows:\n\n  * Hepatic: Serum total bilirubin ≤ 1.5 mg\u002FdL, unless benign congenital hyperbilirubinemia or unless thought to be disease related.\n  * Hepatic: ALT and AST \\\u003C 3 times the upper limit of normal unless thought to be disease-related.\n  * Renal: serum creatinine \\\u003C 2.0 mg\u002F100 ml (\\> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age\n* If serum creatinine is outside the normal range, then CrCl \\> 40 mL\u002Fmin\u002F1.73m2 (calculated or estimated) or GFR (mL\u002Fmin\u002F1.73m2) \\> 40% of predicted normal for age.\n\nNormal GFR by Age Age: 1 week \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 40.6 + \u002F - 14.8 Age: 2 - 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 65.8 + \u002F - 24.8 Age: \\> 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 95.7 +\u002F- 21.7 Age: 2 - 12 years \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 133 +\u002F- 27 Age: 13 - 21 years (males) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 140 +\u002F- 30 Age: 13 - 21 years (females) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 126.0 + \u002F - 22.0 Abbreviations: GFR, glomerular f filtration rate; SD, standard deviation\n\n* Greater than 2 years old: Normal GFR is 100 mL\u002Fmin\u002F1.73m2.\n* Infants: GFR must be corrected for body surface area.\n\n  * Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.\n  * Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry\n\nExclusion Criteria:\n\nSubject Exclusion: Collection of T cells (Part A)\n\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished\n* Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\u002F\n\nSubject Exclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Bridging chemotherapy occurring \\\u003C 1 week prior to administration of LDC\n\n  o Exception: hydroxyurea can be continued up to 72 hours prior to leukapheresis or 24 hours prior to LDC\n* Pregnant or lactating women\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Isolated extramedullary disease\n* Lack of a suitable donor\u002Fsource for allogeneic HSCT as determined by the treating physician.\n* Patients with prior alloHCT are allowed as long as alloHCT occurred ≥100 days prior to date of treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells and as long as the patient is without ongoing requirement for systemic graft-versus-host therapy\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan.\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \\> 2 years before screening\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n* Any other condition\u002Fissue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.","ALL","1 Year",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.",[26,27,28,29,30],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[26,27,28,29,30,32,33,34,35,36,37],"ArmoRed","CLEAR-AML","CLEc12a","CD371","Memorial Sloan Kettering Cancer Center","23-016","RECRUITING","2026-06-18",{"date":41,"type":42},"2026-06-22","ACTUAL",{"date":44,"type":42},"2023-09-01",{"date":46,"type":20},"2026-12-17",{"name":36,"class":48},"OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100529691","phase-1-study-of-revumenib-azacitidine-and-venetoclax-in-pediatric-and-young-adult-patients-with-refractory-or-relapsed-acute-myeloid-leukemia-100529691","NCT06177067","Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","Inclusion Criteria: Participants must have a diagnosis of AML or ALAL and meet the criteria below:\n\n* Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia, defined as the re-appearance of leukemia after the achievement of remission. Patients must have ≥5% blasts in the bone marrow as assessed by morphology or ≥1% blasts flow cytometry.\n\nHowever, if an adequate bone marrow sample cannot be obtained (e.g., in a patient with acute megakaryoblastic leukemia with marrow fibrosis), patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts by morphology or ≥1% blasts flow cytometry in the blood.\n\n* Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A rearrangement (KAT6Ar), or SET::NUP214\n* Adequate organ function, defined as total bilirubin \\\u003C 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin \\\u003C3 × the ULN) unless attributed to leukemia, calculated creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m\\^2, and left ventricular ejection fraction ≥ 40%\n* QTcF \\\u003C 480 msec (average of triplicate)\n* Age ≥ 1 year and ≤ 30 years. The upper age limit may be defined by each institution, but may not exceed 30 years.\n* Lansky ≥ 60 for patients who are \\\u003C 16 years old and Karnofsky ≥ 60% for patients who are \\> 16 years old.\n* At least 14 days or 5 half-lives (whichever is longer) must have elapsed since the completion of myelosuppressive therapy, with the exception of low-dose therapy used for cytoreduction according to institutional standards, such as hydroxyurea or low-dose cytarabine (up to 200 mg\u002Fm\\^2\u002Fday). In addition, all toxicities must have resolved to grade 1 or less.\n* Patients must have a leukocyte count \\\u003C25,000 cells\u002FuL. Low-dose therapy, such as hydroxyurea or cytarabine as described above, to achieve this limit is acceptable.\n* For patients who have received prior HCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HCT, and patients should be off calcineurin inhibitors for at least 28 days prior to the start of protocol therapy. Physiologic prednisone for the treatment of adrenal insufficiency is acceptable..\n* Patients must be taking posaconazole or voriconazole, which must be started at least 24 hours prior to the start of therapy.\n* Patients of reproductive potential must agree to use effective contraception for the duration of study participation.\n\nPatients who meet the criteria listed above are eligible for enrollment and treatment on the trial. However, patients in first relapse who are suitable for and willing to receive intensive remission induction therapy should be offered such therapy if deemed appropriate by the treating physician.\n\nExclusion Criteria:\n\n* Patients who are pregnant or breastfeeding are not eligible.\n* Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.\n* Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.","30 Years",{"count":58,"type":20},24,[23],"This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug.\n\nPrimary Objective\n\n* To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL.\n\nSecondary Objectives\n\n* Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).",[26,27,62],"Acute Leukemia of Ambiguous Lineage","2026-05-01",{"date":65,"type":42},"2026-05-04",{"date":67,"type":42},"2024-04-19",{"date":69,"type":20},"2027-04",{"name":71,"class":48},"St. Jude Children's Research Hospital",10,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100617562","phase-1-imetelstat-combinations-in-relapsed-aml-100617562","NCT07320235","Imetelstat Combinations in Relapsed AML","IMetelstat and Azacitidine With or Without Venetoclax GIveN in rElapsed Acute Myeloid Leukemia (IMAGINE Trial)","IMAGINE","Inclusion Criteria In order to be eligible for participation in this trial,\n\n* Participants must be ≥18 years of age at time of signing the Informed Consent Form (ICF).\n* Participants must voluntarily sign an ICF.\n* Participants must have WHO-confirmed non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available.\n\n  o Participants with isolated extramedullary disease (EMD), including leukemia cutis, are included but not those with active known CNS disease.\n* Participants must have a life expectancy of at least 12 weeks per investigator.\n* ECOG performance status ≤ 3.\n* Women of child bearing potential (WOCBP), defined as a sexually mature woman not surgically sterilized or post-menopausal for at least 24 consecutive months if ≤55 years or 12 months if \\>55 years, must have a negative serum pregnancy test at screening and cycle 1 day 1 and must agree to use highly effective methods of birth control starting with the first dose of study therapy through 6 months after the last dose of study therapy. Highly effective methods of contraception include double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence\n* Male participants should agree to use a highly effective method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy. 8. Must have adequate organ function as demonstrated by the following:\n\n  * Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement or Gilbert's syndrome.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.\n  * Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (measured or estimated by Cockcroft-Gault formula).\n* Ability to adhere to the study visit schedule and all protocol requirements.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria The participant must be excluded from participating in the trial if the participant:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks or within 5 half-lives of the prior investigational agent, whichever is shorter, of the first dose of treatment.\n* Known clinically active central nervous system (CNS) leukemia. a. Prior CNS leukemia will be allowed if the most recent cerebral spinal fluid sample is negative prior to study initiation and there is no clinical suspicion for active CNS disease.\n* Has a white blood cell count \\> 25 x 109\u002FL (hydroxyurea and\u002For continuous cytarabine ≤1 g\u002Fm2 is permitted to meet this criterion).\n* Active Graft Versus Host Disease (GVHD), or any GVHD requiring treatment with immunosuppression, with the exception of topical steroids and systemic steroids at a dose equivalent to prednisone 10mg or less. Any GVHD treatment (including calcineurin inhibitors) must be discontinued at least 28 days prior to Day 1 of study treatment.\n* Participants with a history of other cancers must not be receiving active treatment (with radiation or chemotherapy) and must be free of disease for 2 years prior to the Screening Visit with the exception of localized prostate cancer treated with hormone therapy, breast cancer treated with hormone therapy, localized basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma in situ, concurrent low-grade lymphoma, that is asymptomatic and lacks bulky disease and shows no evidence of progression, and for which the participant is not receiving any systemic therapy or radiation\n* Myocardial infarction or unstable angina within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.\n* Presence of active serious infection. a. If a participant is identified to have COVID-19 during the screening period, participants may be considered eligible if in the opinion of the investigator there are no COVID-19 sequelae that may place the participant at a higher risk of receiving investigational treatment\n* Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n* Known history of uncontrolled human immunodeficiency virus (HIV)\n* Active known systemic hepatitis A, B, or C infection requiring therapy or known cirrhosis.\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or pharmaceutical sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant.\n* Organ transplant recipients other than bone marrow transplant.\n* Women who are pregnant or lactating.\n* Participants with known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of venetoclax, including difficulty swallowing, are not eligible (Part B only).","18 Years",{"count":83,"type":20},36,[23],"IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting toxicities of imetelstat when administered in combination with a fixed dose of azacitidine. Part B will consist of a phase 1b trial employing a BOIN12 design to determine the optimal biological dose of imetelstat, starting at a lower dose level, in combination with azacitidine and venetoclax. Total of up to 36 participants will be accrued over 54 months at Mount Sinai Hospital. Estimated duration of trial is 114 months including recruitment, screening, treatment, and follow-up.",[27],[88,28,89,27,90,91],"IMAGINE Trial","AML","Imetelstat","Imetelstat and Azacitidine","2026-04-17",{"date":94,"type":42},"2026-04-22",{"date":96,"type":42},"2026-01-02",{"date":98,"type":20},"2035-06-15",{"name":100,"class":48},"Douglas Tremblay",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":101},"100423737","phase-1-venetoclax-and-clag-m-for-the-treatment-of-acute-myeloid-leukemia-and-high-grade-myeloid-neoplasms-100423737","NCT04797767","Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms","A Phase 1\u002F2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (per the World Health Organization \\[WHO\\] 2016 classification) or high-grade myeloid neoplasm (\\>= 10% myeloid blasts in peripheral blood or marrow as assessed by morphology or multiparameter flow cytometry at initial presentation). Patients with biphenotypic or mixed phenotype acute leukemia are eligible.\n* PHASE I:\n\n  * Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines\n  * Relapsed\u002Frefractory patients presenting for trial entry must require first or subsequent salvage therapy and have detectable blasts in peripheral blood or \\>= 5% blasts in bone marrow, as assessed by morphology or multiparameter flow cytometry; or extramedullary myeloid sarcoma, per European LeukemiaNet 2017 guidelines.\n  * These patients are only allowed in the phase 1 portion of the trial\n* PHASE II: Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2022 guidelines\n* Age \\>= 18 years\n* Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3.0 X upper limit of normal (ULN)\n* Bilirubin =\\\u003C 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n* Subject must have adequate renal function as demonstrated by a creatinine clearance \\>= 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Left ventricular ejection fraction (LVEF) \\>= 45%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 3 months prior to study day 0 or after most recent anthracycline administration if appropriate and no clinical evidence of congestive heart failure\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Treatment-related mortality (TRM) score \\\u003C 13.1\n* Female subjects of childbearing potential must have negative results for pregnancy test. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n* Ability to understand and the willingness to sign a written informed consent document\n* White blood cell count in peripheral blood must be \\\u003C 25,000\u002Ful prior to initiation of study therapy (CLAG-M plus venetoclax). Cytoreduction with hydroxyurea and\u002For cytarabine (e.g., 500 mg\u002Fm\\^2 per dose) is allowed to decrease the risk of tumor lysis syndrome\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia or chronic myeloid leukemia in myeloid blast crisis\n* Known active central nervous system (CNS) involvement with acute myeloid leukemia (AML)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic infection, unless disease is under treatment with antimicrobials and considered controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible. Patients with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment would be excluded. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* Known hypersensitivity to any study drug\n* Pregnancy or lactation because of the unknown risks of this combination\n* Concurrent treatment with any other investigational agent\n* Subject is known to be positive for human immunodeficiency virus (HIV)\n* Subjects who cannot discontinue concomitant CYP3A inhibitors, except for voriconazole, prior to cycle 1 day 1 (C1D1)\n* Treatment with any of the following within 7 days prior to the first dose of venetoclax\n\n  * Steroid therapy for anti-neoplastic intent\n* Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges (including marmalade containing Seville oranges)\n  * Star fruit",{"count":110,"type":20},62,[23,112],"PHASE2","This phase I\u002FII trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with CLAG-M may kill more cancer cells.",[115,28,116,117,118,27,119,120,121,26,122,123,124],"Acute Biphenotypic Leukemia","Mixed Phenotype Acute Leukemia","Myeloid Neoplasm","Relapsed Acute Biphenotypic Leukemia","Relapsed Mixed Phenotype Acute Leukemia","Relapsed Myeloid Neoplasm","Refractory Acute Biphenotypic Leukemia","Refractory Mixed Phenotype Acute Leukemia","Refractory Myeloid Neoplasm","Recurrent Myeloid Sarcoma","2026-04-14",{"date":92,"type":42},{"date":128,"type":42},"2022-02-04",{"date":130,"type":20},"2028-12-31",{"name":132,"class":48},"University of Washington",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":101},"100559209","phase-1-tagraxofusp-and-low-intensity-chemotherapy-for-cd123-positive-relapsed-or-refractory-aml-100559209","NCT06561152","Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML","Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria\n\n* Documented diagnosis of relapsed or refractory acute myeloid leukemia (AML) according to World Health Organization (WHO) 2022 criteria\n* Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity\n* Must have received initial therapy with venetoclax in combination with a hypomethylating agent (either azacitidine or decitabine) with no subsequent therapy unless mutations in the IDH or FLT3 genes.\n\nIf mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required.\n\n* Age ≥ 18 years of age\n* ECOG ≤ 2\n* Albumin ≥ 3.2 g\u002FdL at time of screening (note that albumin supplementation is not permitted to enable eligibility)\n* Left ventricular ejection fraction ≥ 50%\n* No clinically significant abnormalities on 12-lead electrocardiogram (ECG) including: complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\>250ms, or QTcF (Friderica's method) \\>450ms in 3 successive measurements\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Females of reproductive potential need to either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with highly effective contraception without interruption prior to starting treatment, during the study therapy, and for 30 days after last dose of study therapy\n* For males of reproductive potential: agreement to use of condoms\n* Adequate hepatic\u002Frenal function defined as:\n\nHepatic function: total bilirubin ≤ 1.5 x ULN (unless attributable to Gilbert's disease or leukemic involvement) AND AST or ALT ≤ 3 x ULN\n\nRenal function: creatinine clearance \\> 30 mL\u002Fminute, calculated by Cockcroft Gault formula\n\n* Women of childbearing potential must have a negative urine or serum pregnancy test\n* Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors\n* Patients who received systemic anti-cancer therapy \\\u003C14 days prior to their first day of study drug administration.\n* Patients who received systemic anti-cancer therapy \\\u003C14 days prior to their first day of study drug administration. Concurrent hydroxyurea will be allowed. Hydroxyurea use will be allowed only during the first cycle if needed for disease control.\n* Significant cardiac disease (any NYHA Class 3 or 4 CHF, uncontrolled angina, history of MI, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication)\n* Any uncontrolled bacterial, fungal, viral or other infection.\n* Known HIV+ or active hepatitis B or C infection, defined as positive viral load for HBV or HCV or a positive surface antigen (HBsAg) test for hepatitis B.\n* The patient has persistent clinically significant toxicities Grade \\>\u002F= 2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).\n* The patient has an active malignancy and\u002For cancer history that may confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of study entry) with substantial potential for recurrence and\u002For ongoing active malignancy must be discussed with study team before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, organ-confined prostate cancer with no evidence of progressive disease.\n* The patient has uncontrolled, clinically significant pulmonary disease (e.g. chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the patient at significant risk for pulmonary complications during the study.\n* The patient has known active or suspected CNS disease. If suspected, CNS disease should be ruled out with relevant imaging and\u002For examination of cerebrospinal fluid.\n* The patient is receiving immunosuppressive therapy - with the exception of low-dose prednisone (\\\u003C\u002F= 10 mg\u002Fday).\n* Received allogenic stem cell transplant prior to the treatment.\n* The patient has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breast feeding",{"count":141,"type":20},20,[23,112],"To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.",[26,27],[146,147,148],"tagraxofusp","cladribine","cytarabine","2026-04-12",{"date":125,"type":42},{"date":152,"type":42},"2025-02-10",{"date":154,"type":20},"2028-10",{"name":156,"class":48},"Stanford University",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":101},"100573088","phase-2-safety-and-efficacy-of-mitoxantrone-hydrochloride-liposome-based-dcmg-regimen-for-rr-aml-100573088","NCT06741722","Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R\u002FR AML","Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed\u002Frefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* The patient has fully understood the study, voluntarily agrees to participate, and has signed the Informed Consent Form (ICF);\n* Age between 18 and 75 years, with no gender restrictions;\n* Confirmed diagnosis of relapsed\u002Frefractory AML (Acute Myeloid Leukemia) by pathology (meeting any one of the following criteria):\n\n  1. Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;\n  2. Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML;\n* Serum total bilirubin ≤ 1.5 times the upper limit of normal, serum ALT and AST both ≤ 2.5 times the upper limit of the normal range, serum creatinine ≤ 1.5 times the upper limit of normal;\n* Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%;\n* Estimated survival time ≥ 3 months;\n* ECOG performance status score of 0-2.\n\nExclusion Criteria:\n\n* The subject's prior anti-tumor treatment history meets one of the following conditions:\n\n  1. Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;\n  2. Previously received doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin \\> 360 mg\u002Fm² (other anthracycline drugs are converted at a ratio of 1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);\n* Cardiac function and disease meet any of the following conditions:\n\n  1. Long QTc syndrome or QTc interval \\> 480 ms;\n  2. Complete left bundle branch block, second-degree or third-degree atrioventricular block;\n  3. Severe, uncontrolled arrhythmia requiring medication;\n  4. New York Heart Association (NYHA) classification ≥ Class II;\n  5. Ejection fraction (EF) \\\u003C 50% or below the lower limit of normal for the study center's laboratory;\n  6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinically significant pericardial disease, or evidence on electrocardiogram of acute ischemia or active conduction system abnormalities within 6 months prior to enrollment.\n* Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug;\n* Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.);\n* Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast\u002Fcervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years);\n* Active hepatitis B or C infection during the viremic phase (Hepatitis B testing: if either HBsAg or core antibody is positive, add HBV-DNA testing; viral DNA levels exceeding 1x10\\^3 copies\u002FmL; Hepatitis C testing: if HCV antibody is positive, add HCV-RNA testing; viral RNA levels exceeding 1x10\\^3 copies\u002FmL);\n* Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n* Pregnant women, breastfeeding women, patients who refuse to use effective contraception during the study period;\n* Significant neurological or psychiatric history;\n* Patients deemed unsuitable for participation in this study by the investigator.","75 Years",{"count":141,"type":20},[112],"The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. This project initiates a prospective and exploratory clinical study on the DCMG chemotherapy regimen for the treatment of relapsed\u002Frefractory AML (Acute Myeloid Leukemia). The study aims to evaluate the efficacy and safety of the DCMG combination chemotherapy regimen in treating relapsed\u002Frefractory AML.",[89,27,26],[89,170,28,171,172],"mitoxantrone liposome","relapsed\u002Frefractory AML","DCMG chemotherapy","2024-12-20",{"date":175,"type":42},"2024-12-27",{"date":177,"type":42},"2024-10-31",{"date":179,"type":20},"2027-12-31",{"name":181,"class":48},"Beijing 302 Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":101},"100557349","phase-2-va-combined-with-pd-1-inhibitor-for-the-treatment-of-relapsed-and-refractory-aml-and-high-risk-mds-100557349","NCT06536959","VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS","A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS","Inclusion Criteria:\n\n* Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.\n* Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.\n* Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.\n* The toxic and side effects caused by the last treatment should be recovered.\n* Eastern Cooperative Oncology Group score of 0 to 3 points.\n* The organ function is intact.\n\n  * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).\n  * Creatinine≤2×ULN.\n  * Bilirubin≤2×ULN.\n* Karnofsky≥70.\n* The expected survival period is at least 12 weeks.\n* Non-pregnant, non-breastfeeding women.\n\nExclusion Criteria:\n\n* Suffering from other untreated or unrelieved malignant tumors within 2 years.\n* Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.\n* Suffering from any other known serious and\u002For uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \\[NYHA\\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.\n* Patients who are unwilling or unable to comply with the protocol.\n* Currently being treated with other systemic anti-tumor or anti-tumor research drugs.\n* Women who are pregnant or breastfeeding.","70 Years",{"count":191,"type":20},67,[112],"The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed\u002Frefractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed\u002Frefractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.",[27,26,195,196],"Myelodysplastic Syndromes","Minimal Residual Disease",[198,199,200],"Venetoclax","Hypomethylation agen","PD-1 inhibitor","2024-07-31",{"date":203,"type":42},"2024-08-05",{"date":205,"type":42},"2024-07-18",{"date":207,"type":20},"2027-07-31",{"name":181,"class":48}]