[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-in-relapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-in-relapse":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,50,76,104,130,155,187,233,255,276,297,320,342,361,383,408,460,482,507,531,553,580,604,624],{"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":49},"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",7,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100593789","phase-1-a-study-of-natural-killer-cells-in-combination-with-atezolizumab-in-people-with-acute-myelogenous-leukemia-100593789","NCT07011004","A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia","Phase I Study of Cytokine Induced Memory-Like Natural Killer Cells Combined With Atezolizumb in Subjects With Relapsed or Refractory Acute Myelogenous Leukemia","Inclusion Criteria:\n\nDisease specific inclusion criteria:\n\n* Subjects must have histologically confirmed acute myeloid leukemia that meets any of the following criteria:\n\n  * Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as daunorubicin\u002Fanthracycline OR a single monthly cycle of a hypomethylating agent with venetoclax.\n  * Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.\n  * Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.\n  * Patients with mutations in IDH1 or IDH2 must be refractory to at least one commercially available inhibitor of IDH1 or IDH2, respectively.\n  * Relapsed AML when relapse occurred within 6 months of achieving an initial complete remission.\n  * Patients must have either failed prior FDA approved agents or, in the opinion of the treating physician, have a sufficiently low probability of response to existing FDA approved agents to warrant treatment on an investigational protocol.\n\nOther inclusion criteria:\n\n* Patients aged 18 through 70 years old are eligible.\n* Must have an available, haplotype mismatched related individual that meets criteria for cell donation according to the FACT guidelines.\n* Patients must have Karnofsky performance status ≥70%.\n* Adequate cardiac function as defined as a systolic LV ejection fraction ≥50% at rest and absence of New York Heart Association stage III or IV congestive heart failure.\n* Adequate pulmonary function as defined as a resting SpO2 ≥ 92% on room air at rest.\n* Serum bilirubin ≤ 5 mg\u002FdL.\n* AST and ALT ≤ 2.5x ULN unless thought to be disease related.\n* Estimated or measured creatinine clearance \\> 50 mL\u002Fmin.\n* Subjects must be free from all systemic immune suppression for at least 4 weeks prior to the start of intended therapy.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.\n* Negative HIV test at screening.\n* Negative hepatitis B surface antigen (HBsAg) test at screening OR positive HBsAg is allowed if a negative HBcAb or a negative quantitative hepatitis B virus (HBV) (DNA \\\u003C 500 IU\u002FmL) assay are documented.\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.\n* For patients receiving therapeutic anticoagulation: Stable anticoagulant regimen for 2 weeks prior to enrollment.\n* Timing of treatment relative to prior therapies:\n\n  * Bridging therapy with hydrea is allowed but is required to be tapered off prior to NK infusion.\n  * Any experimental biological treatments must be discontinued for at least 5 half-lives prior to initiation of study therapy.\n  * Patients must be \\>5 half-lives from receipt of other cytotoxic or targeted therapy.\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic cell transplantation.\n* Subjects with active\u002Funcontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.\n* Subjects requiring systemic immunosuppression for any indication are excluded.\n* Significant cardiovascular disease, as defined by:\n\n  * New York Heart Association Class II or greater congestive heart failure.\n  * Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment\n  * Unstable arrhythmia\n  * Unstable angina\n* Subjects with isolated extramedullary disease without evidence of bone marrow involvement by immunohistochemistry.\n* Female patients who are pregnant or breast-feeding or intend to become pregnant during study treatment or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment with atezolizumab.\n* Severe or uncontrolled infection prior to initiation of study treatment.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, excluding prophylactic antimicrobial agents.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected calcium greater than ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area.\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n    * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Persons who do not meet the age and organ function criteria specified above.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n\nDonor Inclusion Criteria:\n\n* Donors must be eligible for apheresis according to standard FACT guidelines.\n* Donors must not have an HLA genotype reactive against anti-HLA antibodies in the recipient.","18 Years","70 Years",{"count":60,"type":20},18,[23],"The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed\u002Frefractory acute myelogenous leukemia (AML). The researchers will also look at whether the treatment combination works against participants' cancer.",[30,29],[65,66,67],"Atezolizumab","CIML-NK (Cytokine Induced Memory-Like Natural Killer Cells)","24-356","2026-06-16",{"date":70,"type":42},"2026-06-17",{"date":72,"type":42},"2025-05-30",{"date":74,"type":20},"2028-05",{"name":36,"class":48},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100551356","master-framework-for-relapse-or-refractory-acute-myeloid-leukemia-100551356","NCT06459024","Master Framework For Relapse or Refractory Acute Myeloid Leukemia","Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes","IMPACT STREAM","Inclusion Criteria:\n\n* Patients with AML diagnosis according to WHO2022 or ICC2022\n* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria\n* Participant or his\u002Fher legal representative is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.","6 Years",{"count":86,"type":20},4000,"OBSERVATIONAL","This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites",[29,30],[91,92,28,93],"Relapsed","Refractory","Framework","2026-06-09",{"date":96,"type":42},"2026-06-10",{"date":98,"type":42},"2024-06-28",{"date":100,"type":20},"2032-07",{"name":102,"class":48},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",38,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100544732","phase-1-a-study-to-investigate-apl-4098-alone-and-in-combination-in-adults-with-aml-or-mds-100544732","NCT06372717","A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS","A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome\u002FAML (MDS\u002FAML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R\u002FR AML), myelodysplastic syndrome (MDS)\u002F AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R\u002FR AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.\n* WBC count ≤ 25,000\u002Fmicroliter\n* ECOG Performance Status of ≤ 2\n* Weight ≥ 40kg\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening\n* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening\n* Diagnostic assessments: Left ventricular ejection fraction \\\u003C 45%, Fridericia's corrected QT interval \\> 470msec, Aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 x upper limit of normal (ULN), total bilirubin \\> 1.5 x ULN, calculated or measured creatinine clearance \\\u003C 45 mL\u002Fminute (multiply by 0.85 if female)\n* Infectious disease: HIV positive, active hepatitis B and\u002For C",{"count":112,"type":20},100,[23],"This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)\u002FAML and MDS-excess blasts (EB).",[30,116,117,29,118],"Myelodysplastic Syndrome Acute Myeloid Leukemia","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia (AML)","2026-05-29",{"date":121,"type":42},"2026-06-01",{"date":123,"type":42},"2024-06-04",{"date":125,"type":20},"2027-05-01",{"name":127,"class":128},"Apollo Therapeutics Ltd","INDUSTRY",9,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100621700","phase-1-adoptive-t-cell-therapy-with-dcaml-fusion-vaccine-plus-decitabine-and-venetoclax-in-aml-100621700","NCT07374029","Adoptive T Cell Therapy With DC\u002FAML Fusion Vaccine Plus Decitabine and Venetoclax in AML","A Phase 1, First in Human Study of Adoptive T Cell Therapy With T Cells Stimulated by Dendritic Cell (DC)\u002FTumor Fusions in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria Prior to Tumor Collection\n\n* Patients must have AML at initial diagnosis for which decitabine\u002Fvenetoclax is planned as standard of care therapy. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine\u002Fvenetoclax regimen is preferred per the treating physician.\n* Patients with AML in first relapse after cytotoxic and\u002For targeted therapy for which decitabine and venetoclax therapy is appropriate standard of care. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine\u002Fvenetoclax regimen is preferred per the treating physician.\n* ECOG performance status ≤ 2 (Appendix A)\n* Participants must have normal organ and marrow function as defined below:\n\n  * total bilirubin≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3 × institutional upper limit of normal\n  * creatinine ≤ 2.0 mg\u002Fdl\n* The effects of vaccine stimulated T cells on the developing human fetus are unknown. For this reason, 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 and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria Prior to Tumor Collection\n\n* Patients diagnosed with acute promyelocytic leukemia\n* Patients treated at initial diagnosis who are appropriate for intensive induction therapy.\n* Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are allowed.\n* Patients who have received a prior allogeneic transplant will be excluded.\n* Because of compromised cellular immunity, patients who have active human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).\n* Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.\n* Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.\n\nInclusion Criteria Prior to Leukapheresis\n\n* Patients must have obtained a response of PR or better to decitabine and venetoclax as defined in Section 11.\n* Resolution of all HMA\u002Fvenetoclax related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia.\n* Laboratories:\n\n  * ANC ≥ 1,000\u002FµL\n  * Platelets ≥ 50,000\u002FuL\n  * Bilirubin ≤ 2.0 mg\u002FdL\n  * Creatinine ≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3.0 x ULN\n\nExclusion Criteria Prior to Leukapheresis\n\n* Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure\n* Patients who, with their treating physician, choose to proceed with an allogeneic transplant at the time of remission will not be eligible for leukapheresis\n* Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are permitted.\n* Current or prior use of immunosuppressive medication within 14 days prior to first T cell infusion. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg\u002Fday of prednisone or equivalent\n* Known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).\n* Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting treatment, including dosing interruptions through 90 days after last dose of treatment. Refrain from egg cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.\n* Male subjects who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last dose of treatment. Refrain from sperm cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.\n\nInclusion Criteria Prior to Treatment with DC\u002FAML Primed T cells and DC\u002FAML fusion vaccine\n\n* Patient completed 4 cycles of decitabine and venetoclax without evidence of disease recurrence or progression\n* Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia, at the time of initiation of cycle 5, 6, or 7 of decitabine\u002Fvenetoclax therapy.\n* Laboratories:\n\n  * ANC ≥ 1,000\u002FµL\n  * Platelets ≥ 50,000\u002FuL\n  * Bilirubin ≤ 2.0 mg\u002FdL\n  * Creatinine ≤ 2.0 mg\u002FdL\n  * AST\u002FALT ≤ 3.0 x ULN\n* Generation of adequate yield of T cells to meet dosing requirement",{"count":138,"type":20},30,[23],"The goal of this research study is to test if the combination of a new T cell therapy (dendritic cell (DC) \u002F acute myeloid leukemia (AML) primed T cells), vaccine (DC\u002FAML fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and effective for treatment of acute myeloid leukemia (AML).\n\nThe names of the study drugs involved in this study are:\n\n* DC\u002FAML fusion vaccine (immune cell vaccine)\n* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)\n* DC\u002FAML Primed T cells (immune cells)\n* Decitabine (a type of chemotherapy drug)\n* Venetoclax (a type of antineoplastic agent)",[28,29],[118,143,144],"Newly Diagnosed Acute Myeloid Leukemia (AML)","Relapsed Acute Myeloid Leukemia (AML)","2026-05-04",{"date":147,"type":42},"2026-05-05",{"date":149,"type":42},"2026-02-12",{"date":151,"type":20},"2030-10-01",{"name":153,"class":48},"David Avigan",1,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":154},"100417497","phase-1-study-of-c6-ceramide-nanoliposome-cnl-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100417497","NCT04716452","Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase I Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (RR-AML)","KNAN2001","Inclusion Criteria:\n\n1. Signed informed consent is obtained prior to conducting any study-specific screening procedures.\n2. Willing and able to understand the nature of this study and to comply with the study and follow-up procedures.\n3. Age and Disease: ≥ 18 years of age with refractory or relapsed AML\n\n   Refractory AML: Patients who fail to achieve a complete remission (CR) or a complete remission with incomplete count recovery (CRi) after one or more ines of AML directed therapy.\n\n   Relapsed AML: Patients who achieved a complete remission (CR) or a complete remission with incomplete count recovery (CRi) with one or more prior lines of AML directed therapy but then developed a relapse of AML.\n\n   Note: Patients are eligible even if they have not received intensive induction chemotherapy but have been treated with other AML directed therapy like hypomethylating agents (azacitidine, decitabine).\n4. Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.\n5. ECOG performance status must be ≤2\n6. Peripheral white blood cell (WBC) count \\\u003C30,000\u002FµL. For cyto-reduction, the following are allowed to reduce WBC count to \\\u003C 30,000\u002FµL:\n\n   * hydroxyurea is allowed during screening and through the end of Cycle,\n   * cytarabine is allowed during screening but not after registration and should be limited 1 g\u002Fm2 or less from time of consent to registration.\n7. Adequate organ function as evidenced by the following laboratory findings:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or \\\u003C 3 x ULN for patients with Gilbert-Meulengracht Syndrome\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN if not attributed to leukemia, or ≤ 5 x ULN if attributed to leukemia\n   * Creatinine clearance \\> 60 mL\u002Fmin.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are ineligible for study entry:\n\n1. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n2. Patients may not be receiving any other concurrent investigational agents during study treatment and not for at least within one week prior to starting study treatment.\n3. Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.\n4. History of any other malignancies within the preceding 12 months before registration with the exception of in-situ cancer, non-muscle invasive bladder cancer, non-metastatic prostate cancer, basal or squamous cell skin cancer.\n5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk.\n6. Evidence of isolated extramedullary disease.\n7. Acute Promyelocytic Leukemia.\n8. AML with active central nervous system (CNS) involvement (as determined by study investigator).\n9. Severe infection requiring treatment that would interfere with study drug(s) or study participation in the opinion of the treating investigator.\n10. Past Hematopoietic stem cell transplant (HSCT) with graft vs host disease, immunosuppression other than low dose prednisone (10 mg) (or equivalent does of another immunosuppressant) within the 4 weeks before registration.\n11. All adverse reactions from prior therapy must have recovered to Grade ≤ 1 or acceptable baseline per treating investigator.",{"count":19,"type":20},[23],"The study objective is to evaluate patient safety for patients with refractory and relapsed AML being treated with Ceramide NanoLiposome (CNL) .",[29,167,168],"Acute Myeloid Leukemia, Refractory","Refractory\u002FRelapse Acute Myeloid Leukemia",[28,91,92,170,171,172,173,174,175,176,177],"Ceramide","AML","NanoLiposome","Relapsed\u002FRefratory Acute Myleoid Leukemia","NanoLiposomes","Safety","CNL","Ceraxa","2026-03-26",{"date":180,"type":42},"2026-03-31",{"date":182,"type":42},"2025-10-01",{"date":184,"type":20},"2026-11-30",{"name":186,"class":128},"Keystone Nano, Inc",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":207,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100495744","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-ziftomenib-in-combination-with-venetoclaxazacitidine-venetoclax-73-or-73quizartinib-in-patients-with-aml-100495744","NCT05735184","A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax\u002FAzacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML","Phase 1 Study of Venetoclax\u002FAzacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine\u002FDaunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed\u002Frefractory AML\n\n  * Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Adequate liver, renal, and cardiac function according to protocol defined criteria\n* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention\n\n  * Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose\n\nKey Exclusion Criteria:\n\n* Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia\n* Known history of BCR-ABL alteration\n* Advanced malignant hepatic tumor\n* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or WBC \\> 25,000 \u002F microliter. Hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion\n* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia\n* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection\n* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and\u002For leukapheresis and\u002For up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia\n* For relapsed\u002Frefractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \\\u003C 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug\n* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol\n* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)\n\n  * Arm A and Arm B: \\>480 ms on triplicate ECGs\n  * Arm C: \\>450 ms on triplicate ECGs\n* Uncontrolled infection\n* Women who are pregnant or lactating\n* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled\u002Fprogressing\n* Patients who have active GVHD requiring \\>0.5 mg\u002Fkg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment",{"count":195,"type":20},420,[23],"Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.\n\nThis protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.\n\nThe purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.",[28,199,200,201,202,29,203,204,205,206],"Mixed Lineage Leukemia Gene Mutation","Refractory AML","AML With Mutated NPM1","Acute Myeloid Leukemia Recurrent","NPM1 Mutation","KMT2Ar","Myeloid Sarcoma","Nucleophosmin 1-mutated Acute Myeloid Leukemia",[208,209,171,210,211,212,213,214,215,216,217,218,219,220,221,200,29,222],"Leukemia","Myeloid","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Newly diagnosed AML","Untreated AML","venetoclax","cytarabine","daunorubicin","KMT2A-r","NPM1 mutation","quizartinib","2026-03-11",{"date":225,"type":42},"2026-03-13",{"date":227,"type":42},"2023-07-18",{"date":229,"type":20},"2030-04",{"name":231,"class":128},"Kura Oncology, Inc.",44,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":154},"100463646","phase-1-venetoclax-to-augment-epigenetic-modification-and-chemotherapy-100463646","NCT05317403","Venetoclax to Augment Epigenetic Modification and Chemotherapy","A Phase I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria\n\n* Diagnosis\n\n  1. Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow.\n\n     * 1st or greater relapse, OR\n     * Failed to go into remission after 1st or greater relapse, OR\n     * Failed to go into remission from original diagnosis after 2 or more induction attempts\n  2. Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy.\n  3. Patients with treatment related AML (tAML) are eligible. A relapse of tAML is not necessary to enroll on this study thus newly diagnosed tAML are eligible.\n  4. Patients with immunophenotypic AML evolving as lineage switch from ALL or acute leukemia NOS, may be eligible if they have relapsed\u002Frefractory disease\n  5. Patients with Down syndrome are eligible\n* Performance Level- Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age. (See Appendix II for Performance Scales)\n* Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Myelosuppressive chemotherapy\n  2. Cytoreduction with hydroxyurea Hydroxyurea can be initiated and continued for up to 24 hours prior to the start of Venetoclax. It is recommended to use hydroxyurea in patients with significant leukocytosis (WBC \\> 50,000\u002FL) to control blast count before initiation of systemic protocol therapy.\n  3. Patients who relapsed while they are receiving cytotoxic therapy At least 7 days must have elapsed since the completion of the cytotoxic therapy, except Intrathecal chemotherapy.\n  4. Hematopoietic stem cell transplant: Patients who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD), and are at least 90 days post-transplant at the time of enrollment, no longer receiving GVHD therapy.\n  5. Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).\n  6. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair. This includes flotetuzumab.\n  7. Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of monoclonal antibody. (i.e. Gemtuzumab = 36 days)\n  8. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines or CAR-T cells.\n  9. XRT: Craniospinal XRT is prohibited during protocol therapy. No waiting period is necessary for radiation given to non-CNS chloromas; ≥ 90 days must have elapsed if prior TBI or craniospinal XRT.\n  10. Infection Prevention: Patients must be able to tolerate and receive anti-fungal prophylaxis with echinocandins or amphotericin therapy for the duration of their treatment course and neutrophil recovery (post-nadir ANC is \\> 750\u002FμL).\n  11. Inhibitors and Inducers ofCYP3A4\n\n      * Patients taking strong CYP3A4 inhibitors should have their venetoclax dose reduced by 75%\n      * Patients taking moderate CYP3A4 inhibitors should have their venetoclax dose reduced by 50%\n      * Inhibitors of P-glycoprotein (P-gp): Patients taking p-glycoprotein inhibitors should have their venetoclax doses reduced by 50%.\n* Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by the following laboratory values:\n\n  1. Adequate renal function defined as: Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73m2 OR a normal serum creatinine\n  2. Adequate Liver Function Defined as: Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age or normal, AND alanine transaminase (ALT) \\\u003C 5 x ULN for age. The hepatic requirements are waived for patients with known or suspected liver involvement by leukemia. This must be reviewed by and approved by the study chair or vice chair.\n* Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%.\n* Reproductive Function\n\n  1. Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n  2. Female patients with infants must agree not to breastfeed their infants while on this study.\n  3. Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.\n* Informed Consent- Patients and\u002For their parents or legal guardians must be capable of understanding the investigational nature, potential risks, and benefits of the study. All patients and\u002For their parents or legal guardians must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible.\n* Protocol Approval- All institutional, FDA, and OHRP requirements for human studies must be met.\n\nExclusion Criteria\n\n•.Patients will be excluded if they have a known allergy to any of the drugs used in the study.\n\n* Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.\n* Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease.\n* Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.","25 Years",{"count":242,"type":20},40,[23],"The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.",[29,30],"2026-01-09",{"date":248,"type":42},"2026-01-12",{"date":250,"type":42},"2023-03-31",{"date":252,"type":20},"2027-01",{"name":254,"class":48},"Medical College of Wisconsin",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":154},"100485148","phase-1-venetoclax-and-bomedemstat-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100485148","NCT05597306","Venetoclax and Bomedemstat in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","VenBom: A Phase 1 Study of Bomedemstat (IMG-7289), a Novel Inhibitor of Lysine-Specific Demethylase 1 (LSD1), in Combination With Venetoclax in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)","VenBom","Inclusion Criteria:\n\nA. Confirmed diagnosis of one of the following:\n\n1\\. Relapsed\u002Frefractory Acute Myeloid Leukemia (AML) following failure of at least one standard, front-line therapy. Patients must have an AML diagnosis per the World Health Organization (WHO) criteria, regardless of etiology, sub-type or treatment history.\n\nB. Adult male or female patients 18 years of age or older.\n\nC. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 (Appendix A: Performance Status Scales).\n\nD. Patients must satisfy the following laboratory criteria:\n\n1. Total bilirubin ≤ 2 upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin is ≤ 1.5 x ULN of the direct bilirubin.\n2. Alanine aminotransferase (ALT) and aspartate transaminase (AST) must be ≤ 3 × ULN.\n3. Calculated creatinine clearance \\> 50 ml\u002Fmin.\n4. Hemoglobin \\> 8 g\u002FdL (prior red blood cell (RBC) transfusion allowed). Patients may be transfused to achieve this value. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed.\n5. White blood cell (WBC) count \\\u003C 25,000 cells\u002FμL before administration of VenBom on Cycle 1 Day 1. Note: During Cycle 1 only, hydroxyurea may be used to control the level of circulating leukemic blast cell counts to not lower than 10,000 cells\u002FμL.\n6. Platelet count ≥ 20,000 cells\u002FμL before administration of VenBom on Cycle 1 Day 1. Note: Transfusions permitted to achieve this threshold.\n\nE. Suitable venous access to allow for all study related-blood sampling (safety and research).\n\nF. Estimated life expectancy, in the judgment of the Investigator, that will permit receipt of at least 3 months of treatment.\n\nG. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care or other benefits to which they are entitled to receive.\n\nH. Female patients who:\n\n1. Are postmenopausal (No menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of menorrhoea, a single FSH measurement is insufficient.), OR\n2. Are surgically sterile, OR\n3. If they are of childbearing potential: Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception).\n\nI. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n1. Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\n2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception).\n\nJ. Amenable to bone marrow evaluation and peripheral blood sampling at protocol required collection time-points.\n\nExclusion Criteria:\n\nA. Treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug. (Refer to Section 6.3 for instruction on use of strong or moderate Cytochrome P450 (CYP3A) inhibitors\u002Finducers.)\n\nB. Diagnosis of acute promyelocytic leukemia (APL)\n\nC. Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days prior to Cycle 1, Day 1. Exception: Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea to control the level of circulating leukemic blast counts to not lower than 10,000 cells\u002FμL during Cycle 1 of protocol treatment.\n\nD. Candidates for standard and\u002For potentially curative treatments (a candidate is defined as a patient that is both eligible and willing to have these treatments).\n\nE. Major surgery within 14 days before the first dose of study drug or a scheduled surgery during the study period.\n\nF. Grade 2 or higher diarrhea as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 despite optimal anti-diarrheal supportive care within 7 days prior to Cycle 1, Day 1.\n\nG. Known cardiopulmonary disease defined as one of the following:\n\n1. Uncontrolled high blood pressure (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg)\n2. Cardiomyopathy or history of ischemic heart disease. Exception: Patients with ischemic heart disease who have received treatment for acute coronary syndrome (ACS), myocardial infarction (MI), and\u002For coronary artery revascularization surgery (e.g., coronary artery bypass graft, stent) greater than 6 months before screening and who are without cardiac symptoms may enroll.\n3. Congestive heart failure (New York Heart Association (NYHA) Class III or IV or Class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within 4 weeks before screening).\n4. Moderate to severe aortic and\u002For mitral stenosis or other valvulopathy (ongoing).\n5. Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary fibrosis.\n\nH. Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.\n\nI. Uncontrolled human immunodeficiency virus (HIV), defined as dateable viral load.\n\nJ. Known hepatitis B surface antigen seropositive. (Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load if they are to participate in this study.)\n\nK. Known active hepatitis C infections. (Note: Patients who are hepatitis C surface antigen-positive are eligible if they have an undetectable hepatitis C viral load.)\n\nL. Females of child-bearing potential who refuse to either practice 2 effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 30 days after the last dose of study drug.\n\nM. Sexually active males who refuse to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (includes males surgically sterilized - i.e., status post vasectomy).\n\nN. Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.\n\nO. Female patients who intend to donate eggs (ova) during the course of this study or within 4 months after receiving their last dose of study drug.\n\nP. Male patients who intend to donate sperm during the course of this study or within 4 months after receiving their last dose of study drug.\n\nQ. Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of study procedures.\n\nR. Symptomatic central nervous system (CNS) involvement.\n\nS. Diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.\n\nT. Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n\nU. Current use of a prohibited medication (Section 4.12) or expected to require any of these medications during treatment with study drug.\n\nV. Patients with uncontrolled coagulopathy or bleeding disorder.\n\nW. Life-threatening illness unrelated to cancer.\n\nX. Patients with impaired decision-making capacity.",{"count":60,"type":20},[23],"This study aims to learn about the safety, tolerability, and different dose levels' safety profiles of Venetoclax and Bomedemstat (VenBom) combination therapy in participants with relapsed or refractory acute myeloid leukemia.",[28,26,29],"2026-01-06",{"date":269,"type":42},"2026-01-08",{"date":271,"type":42},"2022-11-19",{"date":273,"type":20},"2026-11-19",{"name":275,"class":48},"Terrence J Bradley, MD",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":154},"100447339","phase-1-plat-08-a-study-of-sc-daric33-car-t-cells-in-pediatric-and-young-adults-with-relapsed-or-refractory-cd33-aml-100447339","NCT05105152","PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Pediatric And Young Adult Leukemia Adoptive Therapy (PLAT)-08: A Phase 1 Study Of SC-DARIC33 In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Inclusion Criteria:\n\n1. Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age.\n2. AML that expresses CD33 by flow cytometry and meets one of the below definitions:\n\n   1. For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post HCT detectable by flow cytometry\n   2. First relapse of AML ≤ 6 months of initial diagnosis\n   3. First relapse of AML \\> 6 months after initial diagnosis, with MRD of \\>0.1% by flow cytometry (MPF) after at least one re-induction (single cycle) attempt\n   4. Second or greater relapse AML\n   5. Refractory AML, defined as \\>1% leukemic cells determined by flow cytometry after 2 cycles of induction chemotherapy\n3. Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.\n4. Life expectancy ≥ 8 weeks\n5. Has an appropriate stem cell donor source identified\n6. Lansky performance status score of ≥ 50 for subjects \\\u003C16 years of age or Karnofsky score ≥ 50 for subjects ≥ 16 years. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status\n7. If a subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of DARIC T cells, the subject must discontinue all anticancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy:\n\n   a. Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to enrollment, with the exception of intrathecal chemotherapy for which there is not a required washout period b. Must be ≥ 30 days from last gemtuzumab ozogamicin dose. c. Steroid use: All corticosteroid therapy (unless physiologic replacement dosing) must be discontinued ≥ 7 days prior to enrollment d. Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to enrollment e. Hydroxyurea: must be discontinued ≥ 1 day prior to enrollment. f. Gene Modified cellular therapy: i. must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR ii. must be at least 60 days from most recent gene modified cell therapy\n8. Adequate organ function as indicated by:\n\n   1. Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN)\n   2. Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg\u002FdL AND ALT (SGPT) ≤ 5 times ULN\n   3. Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram\n   4. Respiratory: Oxygen saturation ≥ 92% on room air without supplemental oxygen or mechanical ventilation\n9. Laboratory values meet the following criteria:\n\n   a. Subjects requiring apheresis: Absolute Lymphocyte Count (ALC) ≥ 100 cells\u002FuL b. Virology Testing negative within 3 months prior to enrollment, to include: i. HIV antigen \\& antibody ii. Hepatitis B surface antigen iii. Hepatitis C antibody OR if positive, Hepatitis C PCR is negative\n10. If subject is of childbearing or child-fathering potential, must agree to use highly effective contraception from the time of initial consent through 12 months following the infusion of investigational product on this trial.\n11. Subject and\u002For legally authorized representative has signed the Informed Consent Form for this study\n\nExclusion Criteria:\n\n1. Active malignancy other than acute myeloid leukemia\n2. History of symptomatic non-AML CNS disease or ongoing symptomatic CNS disease requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 1 month are eligible).\n3. CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and DARIC T cell infusion\n4. If history of allogeneic stem cell transplant: active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment\n5. Presence of active severe infection, defined as:\n\n   i. positive blood culture within 48 hours of enrollment, OR ii. fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment\n6. Primary immunodeficiency syndrome\n7. Subject has received prior virotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For legally authorized representative unwilling to provide consent\u002Fassent for participation in the 15-year follow-up period, required if DARIC T cell therapy is administered\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol\n11. Considered by the investigator to be unable to tolerate a lymphodepleting regimen\n12. Subject has a contraindication to receiving rapamycin","30 Years",{"count":60,"type":20},[23],"A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).",[28,30,29],"2025-12-16",{"date":290,"type":42},"2025-12-23",{"date":292,"type":42},"2021-11-29",{"date":294,"type":20},"2041-01-31",{"name":296,"class":48},"Seattle Children's Hospital",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100558538","phase-1-safety-of-mt-401-ots-in-patients-with-relapsed-aml-or-mds-100558538","NCT06552416","Safety of MT-401-OTS in Patients With Relapsed AML or MDS","A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)","RAPID","Inclusion Criteria:\n\n* General\n\n  1. Must be ≥ 65 years of age and capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF\n  2. Must have a life expectancy ≥ 12 weeks\n  3. Must have an ECOG performance status of 0-2\n  4. Must have available MT-401-OTS product with a ≥ 2\u002F8 HLA match Disease Characteristics\n  5. For participants with AML:\n\n     1. Must have a confirmed diagnosis of AML or MDS\u002FAML per 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic\u002FDendritic Neoplasms or 2022 International Consensus Criteria\n     2. Must have intermediate or high-risk disease based on ELN 2022 criteria.\n     3. If no targetable mutation is present, must have received 1 prior standard regimen with at least 4 cycles of standard therapy containing an HMA or a standard cytarabine-containing induction therapy\n     4. If targetable mutation is present, must have received a regimen that includes commercially available targeted therapy unless unable to tolerate or the participant declines (must be documented in the informed consent). If targeted therapy was not administered as part of first-line of therapy, a second regimen is allowed.\n     5. Must have either: ≤ 10% bone marrow blasts and ≤ 5% peripheral blasts during screening and not be considered to have hyperproliferating disease at diagnosis or after treatment OR Evidence of MRD based on evaluation at a local laboratory\n  6. For participants with MDS:\n\n     1. Must have confirmed diagnosis of MDS based on 2022 WHO Classification of Haematolymphoid Tumours: Myeloid and Histiocytic\u002FDendritic Neoplasms or 2022 ICC criteria\n     2. Must have high-risk or very-high-risk disease based on IPSS-M (ie, not evolved to AML)\n     3. Must have received standard treatment with at least 4 cycles of an HMA and have evidence of continued disease, including morphologic disease or MRD-positive\n     4. Must have bone marrow blasts ≤ 10% at screening Health Status\n  7. Must have adequate coagulation, hepatic, renal, and cardiac function:\n\n     1. PT\u002FINR and PTT\u002FaPTT \\\u003C 1.3 × ULN\n     2. AST and ALT \\\u003C 3 × ULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT \\\u003C 5 × ULN is permitted.\n     3. Total bilirubin ≤ 1.5 × ULN unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin (2 × ULN is permitted)\n     4. eGFR ≥ 40 mL\u002Fmin by the MDRD formula\n     5. LVEF ≥ 45% (prior to apheresis and lymphodepletion) Sex\n  8. Women of childbearing potential are eligible to participate if they agree to the following during the intervention period and for at least 1 year after the last infusion of MT-401-OTS:\n\n     1. Must use a contraceptive method that is highly effective (ie, with a failure rate of \\\u003C 1% per year; see Section 10.3), preferably with low user dependency PLUS\n     2. Must agree not to donate eggs (ie, ova and oocytes) for the purpose of reproduction\n  9. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-401-OTS:\n\n     1. Must refrain from donating sperm\n\n        PLUS either:\n     2. Must be abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n     3. Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception (see Section 10.3) as a condom may break or leak\n\nExclusion Criteria:\n\n* Disease-Related\n\n  1. Have leukemic involvement in the CNS\n  2. Have other extramedullary disease involvement (except hepatosplenic involvement)\n  3. Have APL Medical Conditions\n  4. Have primary immunodeficiency\n  5. Have severe or uncontrolled autoimmune disorder\n  6. Have a history or presence of clinically relevant CNS pathology, such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis\n  7. Have active malignancies (ie, those that are progressing or have required treatment change in the last 24 months) other than the disease being treated under study. Exceptions to this inclusion include the following:\n\n     1. Nonmelanoma skin cancer treated within the last 24 months that is considered completely cured\n     2. Adequately treated breast lobular carcinoma in situ and breast ductal carcinoma in situ\n     3. Adequately treated cervical carcinoma in situ without evidence of disease\n     4. History of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen-deprivation therapy\n     5. A malignancy that is considered cured with minimal risk of recurrence\n  8. Have any active systemic infection requiring therapy (viral, bacterial, or fungal), including HIV\n  9. Have active hepatitis B or C infection or other clinically active liver diseases, as defined below:\n\n     1. Seropositivity for hepatitis B as defined by a positive test for HbsAg Participants with resolved infection (ie, participants who are HbsAg-negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Those who are RT PCR-positive will be excluded.\n\n        Participants with serologic findings suggestive of HBV vaccination (anti HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT PCR.\n     2. Active hepatitis C infection as defined by being positive for a nucleic acid test for HCV RNA\n  10. Have Class III or IV congestive heart failure per New York Association\n  11. Have unstable angina\n  12. Have a history or evidence of current, uncontrolled, clinically significant, unstable arrhythmias\n  13. Have an oxygen saturation on room air of ≤ 92%\n  14. Have clinically significant reversible nonhematologic toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline Note: Participants with clinically nonsignificant toxicities, such as asymptomatic laboratory values, will be allowed on study.\n\n      Prior\u002FConcomitant Therapies\n  15. Received prior treatments for underlying malignancy, except as specified in the Inclusion Criteria. Participants with AML secondary to MDS may have received prior treatment for MDS.\n  16. Have had prior HSCT\n  17. Are receiving concurrent therapies other than HMA, as delineated in the study design\n  18. Have received hematopoietic growth factors within 2 days of lymphodepleting conditioning regimen\n  19. Have a history of severe allergic reactions\u002Fintolerance to any of the study intervention components, including the conditioning regimen, HMA, or DSMO, or to tocilizumab\n  20. Have had major surgery within 14 days (central line placement allowed)\n  21. Have received systemic steroids (exception: physiological doses of steroids allowed) or other immunosuppressive therapies within 14 days prior to lymphodepleting conditioning regimen Other\n  22. Are unable to be matched with MT-401-OTS product inventory\n  23. Are pregnant or breastfeeding\n  24. Have any other issue that, in the opinion of the treating physician, would make the participant ineligible for the study or unable to comply with its requirements","65 Years",{"count":242,"type":20},[23],"This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and\u002For \\\u003C\u002F= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \\\u003C\u002F= 10% blasts following treatment with an HMA-based therapy.",[29,310],"MDS","2025-12-08",{"date":288,"type":42},{"date":314,"type":42},"2025-06-16",{"date":316,"type":20},"2029-09",{"name":318,"class":128},"Marker Therapeutics, Inc.",3,{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":333,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":319},"100585746","a-long-term-follow-up-study-of-patients-with-ard103-car-t-cell-therapies-100585746","NCT06906380","A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies","A Long-term Follow-up Study of Patients Enrolled in ARD103_ARCE-CL-P-001 Phase 1\u002F2 Study and Treated With ARD103 CAR-T Cell Therapies","Inclusion Criteria:\n\n* The participant has R\u002FR AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.\n* The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria for this study",{"count":328,"type":20},49,"This study will evaluate the long-term safety of ARD103 cellular therapies",[29,331,332],"Acute Myeloid Leukemia, in Relapsed or Refractory","MDS (Myelodysplastic Syndrome)","NOT_YET_RECRUITING","2025-12-04",{"date":311,"type":42},{"date":337,"type":20},"2026-03-15",{"date":339,"type":20},"2040-10-31",{"name":341,"class":128},"ARCE Therapeutics, Inc.",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":319},"100568402","phase-1-clinical-study-of-ard103-car-t-therapy-for-patients-with-rr-aml-or-mds-100568402","NCT06680752","Clinical Study of ARD103 CAR-T Therapy for Patients With R\u002FR AML or MDS","A Phase 1\u002F2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic status:\n\n  * Absolute lymphocyte count (ALC) \\> 100\u002Fmm3\n* Adequate renal, hepatic, cardiac and pulmonary function:\n\n  * ALT and AST \\\u003C 3.0 × the ULN\n  * Creatinine clearance ≥ 45.0 mL\u002Fmin as estimated by Cockcroft-Gault and independent dialysis\n  * Total bilirubin ≤ 2.0 mg\u002FdL\n* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test\n* Contraception: males and females of childbearing potential must agree to use an effective method of contraception\n* Participant is capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Presence of active and clinically relevant central nervous system (CNS) disorder\n* Autoimmune disease requiring immunosuppressive treatment\n* Participants with known hepatic bridging cirrhosis\n* Currently active infection with hepatitis B or C\n* Previous treatment with investigational gene or cell therapy (including CAR therapy)\n* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)\n* Previous chemotherapy including biologic\u002Ftargeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration",{"count":328,"type":20},[23,351],"PHASE2","This is a phase I\u002F2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.",[29,30,332],{"date":355,"type":42},"2025-12-10",{"date":357,"type":42},"2025-05-20",{"date":359,"type":20},"2028-12",{"name":341,"class":128},{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":21,"phases":370,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100455516","phase-1-ab8939-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100455516","NCT05211570","AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1\u002F2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","DOSE ESCALATION STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.\n* ECOG performance status ≤ 1\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\nEXPANSION COHORT STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* ECOG performance status ≤ 2\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":369,"type":20},78,[23,351],"The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.",[30,29,116],"2025-09-29",{"date":375,"type":42},"2025-10-02",{"date":377,"type":42},"2022-06-01",{"date":379,"type":20},"2026-12",{"name":381,"class":128},"AB Science",10,{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":21,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":333,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100537747","phase-1-an-adaptive-open-label-multicentre-phase-12-trial-to-determine-the-recommended-phase-2-dose-of-cctx-001-and-to-assess-safety-tolerability-and-clinical-activity-in-patients-with-relapsedrefractory-acute-myeloid-leukaemia-100537747","NCT06281847","An Adaptive Open-label Multicentre Phase 1\u002F2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed\u002FRefractory Acute Myeloid Leukaemia","RESOLVE AML001","Inclusion Criteria:\n\n1. Patients with active (\\> 5 % blasts in bone marrow) r\u002Fr AML (WHO 2022) who have exhausted their therapeutic alternatives or have contraindications to these alternatives as judged by the treating physician defined as either:\n\n   a. Primary refractory: i. Patients who failed after two cycles of intensive induction including high-dose and\u002For standard dose cytarabine (including liposomal formulation), +\u002F- anthracycline, +\u002F- antimetabolite, +\u002F- targeted therapy or ii. Older patients or patients unfit to receive intensive induction courses who failed after two cycles of venetoclax + azacitidine or 4 cycles of azacitidine b. Relapsing: i. Patients with early relapse after CR to first line therapy (within ≤ 6 months after CR1) or ii. Patients with relapse after later lines of therapy (Relapse after CR≥2) c. Patients relapsing after allogeneic hematopoietic stem cell transplant: i. Patients must be at least 3 months from hematopoietic stem cell transplant (HSCT) at the time of consent, and ii. Off immunosuppression for at least 1 month at the time of consent, and iii. Have no active graft versus host disease (GvHD)\n2. Have a circulating blast count of less than 20,000\u002Fmm3 (control with hydroxyurea is allowed)\n3. Absolute Lymphocyte count of \\>200\u002Fmm3\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n5. Life expectancy of more than 3 months\n6. Patient is ≥ 18 years of age at the time of informed consent\n7. Read, understood, and signed the informed consent form (ICF) prior to any study procedures\n8. Patient is willing and able to adhere to the study visit schedule and other protocol requirements\n9. Eligible for leukapheresis\n10. Treatment-related toxicities of previous therapies have completely resolved\n11. Adequate organ function as confirmed by clinical laboratory values, defined as:\n\n    1. Adequate bone marrow function to receive LDC as assessed by the Investigator\n    2. Serum creatinine \\[\\\u003C 1.5 x the upper limit of normal (ULN) or creatinine clearance (CrCl) \\> 45 mL\u002Fmin\\] (estimated by Cockcroft Gault or Modification of Diet in Renal Disease (MDRD); see Appendix 14.3 for calculation)\n    3. Alanine aminotransferase \\[≤ 3 x ULN and total bilirubin \\\u003C 1.5 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL\\] for patients with Gilbert's syndrome or leukemic infiltration of the liver)\\]\n    4. Adequate pulmonary function, defined as \\[≤ Grade 1 dyspnoea according to CTCAE and oxygen saturation (SaO2) ≥ 92% on room air and forced expiratory volume in the first second ≥ 50%\\]\n    5. Ejection fraction \\> 40% assessed by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month before CCTx-001 infusion\n12. Women of childbearing potential\\* (WOCBP) must have a negative serum pregnancy test performed at screening and within 7 days before enrolment\n13. WOCBP or males whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 12 months after the last dose of LDC. For the definition and list of highly effective methods of contraception.\n\nExclusion Criteria:\n\n1. Patients with an acute promyelocytic leukaemia: t(15;17)(q22;q12); (promyelocytic leukaemia\u002Fretinoic acid receptor alpha) and variants\n2. Patients with active central nervous system (CNS) leukaemia involvement. If the patient has prior history of CNS leukaemia, they must have a negative cerebrospinal fluid (CSF) assessment and magnetic resonance imaging (MRI) or computed tomography (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease\n3. Patients with isolated extramedullary AML disease\n4. Patients who received previous treatment targeting IL-1RAP or previous gene therapy\n5. Patients who underwent allo-HSCT within 90 days prior to leukapheresis\n6. Patients who received donor lymphocyte infusion within 60 days prior to leukapheresis\n7. Patients with active GvHD\n8. Patients with history of another primary malignancy other than disease under study unless the patient has been free of the disease for ≥ 2 years, except for the following non-invasive malignancies:\n\n   1. Basal cell carcinoma of the skin\n   2. Squamous cell carcinoma of the skin\n   3. Carcinoma in situ of the cervix\n   4. Carcinoma in situ of the breast\n   5. Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative\n   6. Other completely resected stage 1 solid tumour with low risk for recurrence\n9. Presence of systemic fungal, bacterial, viral, or other infection (including tuberculosis) that is uncontrolled despite appropriate antibiotics or other treatments\n10. Active or prior history of hepatitis B or hepatitis C infection\n11. History of or active human immunodeficiency virus (HIV) infection\n12. Active macrophage activation syndrome (MAS) as evidenced by laboratory abnormalities (e.g.: elevated ferritin, elevated triglycerides, haemophagocytosis on the bone marrow sample) and\u002For clinical signs\n13. History or presence of an active and clinically relevant CNS disorder such as epilepsy, generalised seizure disorder, paresis, aphasia, stroke, cerebral oedema, severe brain injury, dementia, multiple sclerosis, Parkinson's disease, cerebellar disease, organic brain syndrome, or posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement\n14. Patients with active autoimmune disorders or active neurological or inflammatory disorders (e.g., Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis) requiring immunosuppressive therapy or corticosteroid therapy (defined as \\>20 mg\u002Fday prednisone or equivalent). Physiologic replacement, topical, and inhaled steroids are permitted.\n15. Use of the following (see Section 8.3 for full details):\n\n    1. Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days prior to leukapheresis or 72 hours prior to CCTx-001 infusion. Physiologic replacement, topical, and inhaled steroids are permitted.\n    2. Immunosuppressive therapies within 4 weeks prior to signing the ICF (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-tumour necrosis factor \\[TNF\\], anti-IL-6, or anti-IL-6 receptor \\[IL-6R\\])\n    3. Cytotoxic chemotherapeutic agents (including intrathecal) within 14 days prior to leukapheresis.\n    4. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis\n    5. Experimental agents within 4 weeks prior to signing the ICF unless no response or progressive disease (PD) is documented on the experimental therapy and at least 3 half-lives have elapsed prior to signing the ICF.\n    6. Therapeutic anticoagulation\n16. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF:\n\n    1. Class III or IV heart failure as defined by the New York Heart Association\n    2. Cardiac angioplasty or stenting\n    3. Myocardial infarction\n    4. Unstable angina\n    5. Other clinically significant cardiac disease\n17. Known hypersensitivity to DMSO or other excipients\n18. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n19. Abnormal findings and\u002For clinically significant Grade ≥3 non-haematological toxicity and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety.\n20. Presence of any condition that confounds the ability to interpret data from the study based on Investigator´s judgement.\n21. Any planned medical\u002Fsurgical treatment that might interfere with the ability to comply with the study requirements.\n22. Pregnant or nursing women. NOTE: WOCBP must have a negative serum pregnancy test performed within 48 hours of starting LDC",{"count":391,"type":20},143,[23,351],"The purpose of this adaptive Phase 1\u002F2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r\u002Fr Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r\u002Fr AML and provide a potential novel treatment option.",[29,30],[28,91,92,396,175,397],"Open-label","Tolerability","2025-09-12",{"date":400,"type":42},"2025-09-18",{"date":402,"type":20},"2025-12",{"date":404,"type":20},"2041-08",{"name":406,"class":128},"Advesya SAS",6,{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":21,"phases":417,"briefSummary":419,"conditions":420,"keywords":428,"overallStatus":333,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100605053","phase-2-radioimmunotherapy-conditioning-with-131i--apamistamab-for-allogeneic-transplant-in-relapserefractory-aml-100605053","NCT07157514","Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse\u002FRefractory AML","An Adaptive, Operationally Seamless Phase II \u002F III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease","Inclusion Criteria:\n\n1. Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.\n2. 2R\u002FR AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission \\\u003C6 months, relapse refractory to salvage combination therapy or second or subsequent relapse\n3. Documented CD45 expression by leukemic cells via flow cytometry.\n4. ≥18 years of age and not suitable for myeloablative conditioning regimen.\n5. Circulating blast count \\\u003C10,000\u002Fmm³ (hydroxyurea allowed).\n6. Calculated creatinine clearance (Cockcroft-Gault) \\>50 mL\u002Fmin.\n7. Adequate hepatic function: AST\u002FALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).\n8. Karnofsky performance score ≥70.\n9. Expected survival \\>60 days.\n10. Central venous catheter line in place before study treatment.\n11. 8\u002F8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).\n12. Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.\n13. Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.\n14. Able to understand procedures, provide informed consent, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Positive human anti-mouse antibody (HAMA) at screening.\n2. \\>20% leukemic blasts in marrow.\n3. Prior radiation to maximally tolerated levels of any critical organ.\n4. Active CNS leukemia (blasts in CSF or CNS chloromas).\n5. Prior allogeneic or autologous HSCT.\n6. Candidates suitable for myeloablative conditioning.\n7. Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy\n8. QTcF \\>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).\n9. Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).\n10. Active, uncontrolled infection.\n11. Acute promyelocytic leukemia (t\\[15;17\\]).\n12. Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (\\>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression\n13. Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.\n14. Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).",{"count":416,"type":20},306,[351,418],"PHASE3","This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.",[214,421,422,28,29,423,424,425,426,427,200],"Myeloid Leukemia","Acute Myelogenous Leukemia","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Transplant-Related Disorder","Allogeneic Disease",[28,208,429,430,431,432,200,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450],"Acute Myeloid","Acute Bone Marrow Cell Transplant","Transplant","Bone Marrow HCT","Relapsed AML","I-131","Iomab","I131- Apamistamab","Iodine","Iodine-131","131-I AML","Iomab-B","Radioimmunotherapy","Allogeneic Transplant","Radiotherapy","CD45","Anti-CD45 antibody","Apamistamab","Fludarabine","Bone Marrow Transplant","Radiolabeled antibody therapy","131I -apamistamab","2025-09-04",{"date":453,"type":42},"2025-09-10",{"date":455,"type":20},"2026-01",{"date":457,"type":20},"2034-02",{"name":459,"class":128},"Actinium Pharmaceuticals",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":481},"100512182","phase-1-phase-1-study-of-allo-revcar01-t-cd123-in-patients-with-selected-cd123-positive-hematologic-malignancies-100512182","NCT05949125","Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies","Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123","Inclusion Criteria:\n\n1\\. Male or female participants, age ≥18 years. 2. HLA type of participant must match at HLA B and C loci 3.\n\n1. For Phase 1a escalation part of the trial Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)\n\n   (1) for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies.\n2. For Phase 1b expansion part of the trial (Phase 1b) Participants with CD123+ AML (defined as ≥20% of leukemic cells expressing CD123 at any point in the course of disease)\n\n   1. up to 3rd relapse for whom all standard or life-extending therapies have failed and for whom no potentially curative therapies are available or who are intolerant to such therapies\n   2. having up to 30% blasts in a bone marrow assessment at either screening or prescreening, or having between 30% and 40% blasts for two consecutive bone marrow assessments with a minimum of one month and no more than two months apart,\n   3. without hyperproliferative disease requiring cytoreductive treatment,\n   4. exceptions to BM blast criterion are only possible in minor deviations in timing and\u002For blast count in clinically stable patients, and only with written sponsor approval. Exceptions to minimum CD123 expression are not allowed.\n3. For Phase 1a escalation and Phase 1b expansion part of the trial\n\nParticipants with MRD+ AML are potentially eligible but must meet the following criteria:\n\n1. MRD positivity must be based on assays and markers supported by consensus guidelines \\[Heuser2021\\] and in the judgment of the investigator must confer negative prognostic risk highly likely to result in relapse.\n2. must have received or be ineligible for allogeneic stem cell transplant.\n3. must be approved by the Sponsor for inclusion in the study. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months in the judgment of the investigator. 6. Adequate renal and hepatic laboratory assessments: 7. Adequate cardiac function 8. Long-term central venous access existing (e.g., port-system) or willing to have such a device inserted.\n\n9\\. Able to give written informed consent. 10. Weight ≥45 kg. 11. Negative pregnancy; routinely using a highly effective method of birth control\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (t15;17).\n2. AML with only extramedullary manifestations (e.g., chloroma, primary myeloid sarcoma)\n3. Acute manifestationof AML in the central nervous system.\n4. Bone marrow failure syndromes\n5. Cardiac disease: heart failure (New York Heart Association III or IV); unstable coronary artery disease, myocardial infarction, or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within the last 6 months prior to study entry.\n6. Active pulmonary disease with clinically relevant hypoxia\n7. Parkinson's disease or epilepsy with clinical symptoms in the previous 12 months .\n8. Stroke, seizure, or intracranial hemorrhage in the past 12 months.\n9. History or presence of disseminated intravascular coagulation (DIC), deep vein thrombosis or thromboembolism within 3 months prior to start of treatment.\n10. Active infectious disease considered by investigator to be incompatible with protocol or being contraindications for lymphodepletion therapy\n11. Presence of hemorrhagic cystitis\n12. Other toxicity from prior anticancer treatment has not resolved to Grade ≤1 or baseline.\n13. Allogeneic stem cell transplantation within last 2 months or GvHD requiring systemic immunosuppressive therapy.\n14. Vaccination with live viruses \\\u003C 2 weeks prior to lymphodepletion therapy.\n15. Major surgery within 28 days prior to start of R-TM123 infusion.\n16. Prior malignancy in the past 3 years or any malignancy requiring ongoing active therapy other than adjuvant endocrine therapy. Participants with resected or ablated tumors, such as basal cell carcinoma of skin, carcinoma-in-situ of the cervix, or other tumors considered cured may be considered for the study with Sponsor approval.\n17. Treatment with any investigational drug substance or experimental therapy within 4 weeks or 5 half-lives (whichever is shorter) of the substance prior to lymphodepletion.\n18. Treatment with anti-leukemic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n19. Prior treatment with gene modified cell products.\n20. Use of checkpoint inhibitors within 5 half-lives of the specific drug.\n21. Autoimmune diseases requiring systemic steroids or other systemic immunosuppressants.\n22. Pregnant or breastfeeding women.\n23. Psychologic disorders with treatment modifications required within the last 3 months, drug and\u002For significant active alcohol abuse as per investigator's medical judgement. Depression or anxiety due to presence of the underlying malignancy may be exempted with Sponsor approval.\n24. History of human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV) or active\u002Fchronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).\n25. Presence of autoantibodies against lupus La protein (La)\u002F Sjögren syndrome type B antigen (SS-B) or presence or history of autoimmune diseases associated with such antibodies\n26. Known hypersensitivity to cellular component (Allo-RevCAR01-T) and\u002For TM (R-TM123) excipients or to compounds of the lymphodepletion therapy, tocilizumab, or corticosteroids.\n27. Evidence that the participant is not likely or able to follow the study protocol (e.g., lacking compliance) in the judgment of the investigator.\n28. Participant unable to understand the informed consent and possible consequences of the participation in the clinical trial in the judgement of the investigator.",{"count":468,"type":20},80,[23],"The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R-TM123 functions as a bridging module between Allo-RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.",[29,30],"2025-05-09",{"date":474,"type":42},"2025-05-14",{"date":476,"type":42},"2024-01-03",{"date":478,"type":20},"2028-01",{"name":480,"class":128},"AvenCell Europe GmbH",11,{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":154},"100448809","analysis-of-the-immunobiology-of-acute-myeloid-leukemia-relapses-after-allogeneic-hematopoietic-stem-cell-transplant-hsct-for-the-generation-of-guidelines-and-personalized-therapeutic-pathways-100448809","NCT05124288","Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways","Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways","GITMO-RELAPSE","Inclusion Criteria:\n\n* Adult patients with Acute Myeloid Leukemia, who relapse after allogeneic transplantation from either family or unrelated donors, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood), who have signed the informed consent of the study;\n* For the coordinating center, all patients who have previously signed informed consent to the \"Hematological Neoplasms Biobank\" and for which samples, stored in the Biobank are available.\n* For the other centers, all patients who have previously signed an informed consent, aimed at the prior authorization for the storage of samples in the biobank of the aforementioned center, according to centers own practice, and for which samples, stored in a Biobank, are available.\n\nExclusion Criteria:\n\n* Participation in clinical protocols that expressly exclude the possibility of participating in other studies.",{"count":491,"type":20},500,"This is a retrospective and prospective non-interventional multicenter observational study. Neither diagnostic approaches nor experimental drugs\u002Fprocedure will be applied and the samples will take place at the same time as the samples will be taken during routinary clinical practice.\n\nThe aim of this study is to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses after allogeneic HSCT for the generation of guidelines and personalized therapeutic pathways.",[29],[495,496,28,497],"Haematopoietic Stem Cell Transplantation","Graft versus Host Disease","Human Leukocyte Antigens loss","2025-05-07",{"date":500,"type":42},"2025-05-13",{"date":502,"type":42},"2022-07-18",{"date":504,"type":20},"2027-06-20",{"name":506,"class":48},"Ciceri Fabio",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":516,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":154},"100531549","early-phase-1-off-the-shelf-cd123-car-nk-for-rr-aml-100531549","NCT06201247","Off-the-shelf CD123 CAR-NK for R\u002FR AML","Safety and Efficacy of Universal Off-the-shelf CAR-NK Cells Targeted CD123 (JD123 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia","Inclusion criteria:\n\n1. Age ≥ 18 years old, no gender or race;\n2. Expected survival period ≥ 3 months;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria:\n\n   A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; Patients relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT) C. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment.\n5. Adequate organ function:\n\nA. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL\u002Fmin; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active Central nervous system leukemia;\n2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide;\n3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);\n4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.\n5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;\n6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;\n7. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating;\n8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;\n\n10\\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.\n\n\\-",{"count":515,"type":20},12,[517],"EARLY_PHASE1","This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).",[29,30],[28,521],"CAR-NK","2025-03-08",{"date":524,"type":42},"2025-03-11",{"date":526,"type":42},"2023-12-30",{"date":528,"type":20},"2025-12-30",{"name":530,"class":48},"Peking University People's Hospital",{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":552},"100453894","phase-1-a-clinical-trial-of-bp1002-in-patients-with-refractoryrelapsed-acute-myeloid-leukemia-aml-100453894","NCT05190471","A Clinical Trial of BP1002 in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","A Phase I\u002FIb Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory\u002FRelapsed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Adults ≥18 years of age, with histologic evidence of refractory\u002Frelapsed AML who have failed treatment with available therapies known to be active for refractory\u002Frelapsed AML\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2\n3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy\n4. Participants must have adequate hepatic and renal functions as defined by:\n\n   1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and\n   2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And;\n   3. Estimated creatinine clearance of at least 60 mL\u002Fmin. These estimations are calculated using the Cockcroft-Gault equation.\n5. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine\n6. Male participants must agree to use an acceptable method of contraception for the duration of the study\n7. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment\n8. Participants must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months\n2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening\n3. Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required.\n4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA\n5. Chronic myeloid leukemia in any phase\n6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis\n7. Participants may not be receiving any other investigational agents\n8. Female participants who are pregnant or breast-feeding\n9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n10. Participants with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts \\\u003C 350 cells\u002FmcL or with clinically active hepatitis B or C infection\n11. History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor\n12. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia\n13. Presence of concurrent conditions that, in the opinion of the Investigator and\u002For Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \\>470 msec)\n14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident or transient ischemic attack\n15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months)\n16. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason",{"count":539,"type":20},48,[23],"This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory\u002Frelapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).",[29,30],"2025-03-06",{"date":545,"type":42},"2025-03-10",{"date":547,"type":42},"2022-08-16",{"date":549,"type":20},"2027-09",{"name":551,"class":128},"Bio-Path Holdings, Inc.",4,{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":21,"phases":564,"briefSummary":565,"conditions":566,"keywords":570,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":578,"locationsCount":154},"100556974","phase-2-sorafenib-relapase-prophylaxis-after-hct-with-ptbcy-regimen-100556974","NCT06532084","Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen","Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide","SoraGVL","Inclusion Criteria:\n\n* Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.\n* Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:\n\n  * acute myeloid leukemia not in hematological remission prior to transplantation,\n  * ≥ 3 remission of acute myeloid leukemia,\n  * any myeloid malignancy with bi-allelic tp53 mutation,\n  * any myeloid malignancy with complex karyotype,\n  * therapy-related myeloid malignancy not in MRD-negative response\n  * myelodysplastic syndrome with very high IPSS-R risk\n  * any myeloid malignancy with monosomal or t(3;3) karyotype,\n  * any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression\n  * MDS\u002FNPM unclassified not in hematologic remission.\n* Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed\n* First 100 days after allogeneic hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* successfully treated relapse between transplantation and enrollment\n* use of any other planned method for prophylaxis of relapse besides sorafenib\n* donor lymphocyte infusion prior to randomization\n* Second malignancy not in complete remission within 6 months prior to randomization\n* Moderate or severe cardiac disease: ejection fraction \\\u003C50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion\n* Stroke within 3 months of inclusion, unless related to the underlying malignancy\n* Severe decrease in pulmonary function: FEV1 \\\u003C50% or DLCO\\\u003C50% of predicted or respiratory distress or need for oxygen support;\n* Severe organ dysfunction: AST or ALT \\>10 upper normal limits, bilirubin \\>2 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 30 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\\> 70 mg\u002FL\n* Requirement for vasopressor support at the time of enrollment\n* Requirement for positive-pressure oxygen at the time of enrollment\n* Karnofsky index \\\u003C30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent","75 Years",{"count":563,"type":20},88,[351],"This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.",[29,567,568,569],"Myelodysplastic Syndromes","Chronic Myeloid Leukemia","Myeloproliferative Neoplasm",[571],"post-transplantation cyclophosphamide; post-transplantation bendamustine; acute myeloid leukemia; myelodysplastic syndrome; refractory; sorafenib","2024-07-29",{"date":574,"type":42},"2024-08-01",{"date":576,"type":42},"2024-05-22",{"date":74,"type":20},{"name":579,"class":48},"St. Petersburg State Pavlov Medical University",{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":21,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":603},"100481252","phase-1-study-of-iadademstat-and-gilteritinib-in-patients-with-rr-aml-with-fms-like-tyrosine-kinase-mutation-flt3-mut-100481252","NCT05546580","Study of Iadademstat and Gilteritinib in Patients With R\u002FR AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)","An Escalation\u002FExpansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study","FRIDA","Main Inclusion Criteria:\n\n* Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)\n* Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.\n* Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months in the opinion of the investigator.\n* Normal hepatic and renal function.\n* Patient is able to swallow oral medications.\n* Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.\n* Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.\n\nMain Exclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Known BCR-ABL-positive leukemia.\n* AML secondary to prior chemotherapy for other neoplasms (except for MDS).\n* AML that has relapsed after or is refractory to more than 2 lines of therapy.\n* Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.\n* Major surgery or radiation therapy within 4 weeks prior to the first study dose.\n* Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A\u002FLSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and\u002For maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and\u002For maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.\n* Patients not eligible to receive gilteritinib per label.\n* Prior treatment with 3 or more lines of AML therapy.\n* Treatment with any investigational products within 3 weeks prior to first dose of study treatment.\n* Uncontrolled hypertension or poorly controlled diabetes.\n* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.\n* Pregnant or lactating women.",{"count":589,"type":20},50,[23],"Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R\u002FR AML.",[29,30],[594],"Acute Myeloid Leukemia, FLT3 mut","2024-07-26",{"date":572,"type":42},{"date":598,"type":42},"2022-11-14",{"date":600,"type":20},"2025-11-30",{"name":602,"class":128},"Oryzon Genomics S.A.",13,{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":611,"targetDuration":4,"studyType":21,"phases":613,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":622,"locationsCount":154},"100525739","phase-1-administration-of-anti-tim-3cd123-car-t-cell-therapy-in-relapsed-and-refractory-acute-myeloid-leukemia-rraml-100525739","NCT06125652","Administration of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Application of Anti Tim-3\u002FCD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr\u002FAML)","Inclusion Criteria:\n\n1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;\n2. At the age of 18-70 years old;\n3. Diagnosed as relapse\u002Frefractory (r\u002Fr) de novo or secondary acute myeloid leukemia (AML);\n4. The patient has recovered from the toxicity of previous treatment;\n5. ECOG score ≤ 2 and expected survival period is not less than 3 months;\n6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL\u002Fmin; Hemoglobin ≥60g\u002FL ; Indoor oxygen saturation ≥92%; LVEF≥45%;\n7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;\n8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.\n\nExclusion Criteria:\n\n1. Diagnosis of acute promyelocytic leukemia;\n2. History or presence of a CNS disorder;\n3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies \u002FmL;\n4. History of severe hypersensitivity reaction;\n5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;\n6. History of organ transplant surgery;\n7. Required systemic application of immunosuppressive or other drugs;\n8. Auto-SCT within the 3 months before enrollment;\n9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));\n10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;\n11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;\n12. Live vaccine received within the ≤ 4 weeks before enrollment;\n13. Persons with serious mental illness;\n14. History of major surgical operations four weeks before enrollment;\n15. History of alcoholism or substance abuse;\n16. Was identified by the investigators as unsuitable to participate in the study.",{"count":612,"type":20},20,[23,351],"To evaluate the safety and efficacy of anti Tim3\u002FCD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.",[30,29],"2023-11-04",{"date":618,"type":42},"2023-11-09",{"date":616,"type":42},{"date":621,"type":20},"2027-01-01",{"name":623,"class":48},"Xuzhou Medical University",{"id":625,"slug":626,"hasResults":11,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":21,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":640,"locationsCount":642},"100478158","phase-1-treatment-with-abt-199-venetoclax-and-purine-analogues-in-relapsedrefractory-acute-myeloid-leukemia-100478158","NCT05506332","Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed\u002FRefractory Acute Myeloid Leukemia","ABT-199 (Venetoclax) and Purine Analogues as Novel Oral Drug Combination for Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia: the ApoAML Trial","Inclusion Criteria:\n\n* Relapsed or refractory AML\n* Relapsed after or refractory to at least one cycle of intensive chemotherapy (combination of ara-c\u002Fanthracyclin) or four cycles of HMA (hypomethylating agents)\n* Adult AML aged \\>\u002F= 18 years\n* WHO performance status: grade 0-2 at the time of enrollment\n* ABT-199 (venetoclax) and PA-naïve. Patient may be prior exposed but not refractory to venetoclax. In case of previous therapy with venetoclax inclusion is only possible after discussion with the PI.\n\nExclusion Criteria:\n\n* Participation in any other interventional clinical trial during the study period\n* Active presence (or known history of) central nervous system disease\n* History or concomitant presence of any other malignancy, except for non-melanoma skin cancer, carcinoma in situ of the cervix, any other effectively treated malignancy that has been in remission for \\>5 years or that is highly likely to be cured at the time of enrollment.\n* Active HIV, hepatitis B or hepatitis C infection\n* Use of any antitumoral agent within less than 5 times the half-life of the agent prior to the screening bone marrow examination. After the screening bone marrow examination, the use of cytoreductive treatment prior to the initiation of venetoclax is permitted in order to lower the WBC-count to \\\u003C25 000\u002Fµl (e.g. hydroxyurea).\n* Medical conditions requiring chronic therapy of moderate or strong CYP3A4 inducers without alternative\n* Patients with known hypersensitivity to the active substance or to any of the excipients\n* Pregnant or breastfeeding woman\n* Active uncontrolled systemic infection",{"count":382,"type":20},[23],"Non-commercial, open-label interventional phase Ib study to assess the effectivity of the combination of venetoclax and 6-mercaptopurine in patients with relapsed or refractory AML.",[29,30],{"date":636,"type":42},"2022-08-18",{"date":638,"type":42},"2022-07-15",{"date":379,"type":20},{"name":641,"class":48},"University Hospital, Antwerp",2]