[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-acute-myeloid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-acute-myeloid":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643635","phase-2-revumenib-azacitidine-and-venetoclax-in-newly-diagnosed-kmt2a-rearranged-aml-100643635",false,"NCT07605949","Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML","RAVEN","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.\n* Age 18-65 years at the time of consent.\n* Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics\u002Fkaryotype or FISH\n\nExclusion Criteria:\n\n* Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)\n* Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).","ALL","18 Years","65 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML.\n\nPeople with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects.\n\nThe study has two parts:\n\n1. Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.\n2. Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.\n\nPatients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.",[27],"Leukemia Acute Myeloid",[29,30,31,32],"revumenib","azacitidine","venetoclax","allogeneic stem cell transplant","NOT_YET_RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2028-07",{"name":43,"class":44},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100467132","phase-1-a-study-of-mgd024-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100467132","NCT05362773","A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies","A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.\n* Participants with\n\n  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,\n  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \\>3 and \\\u003C20% bone marrow blasts,\n  * classical Hodgkin lymphoma (cHL),\n  * chronic myelogenous leukemia (CML),\n  * b-cell acute lymphocytic leukemia (B-ALL),\n  * hariy cell leukemia (HCL),\n  * advanced systemic mastocytosis (ASM), or\n  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)\n* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.\n* Evidence of at least 20% of malignant cells with CD123 expression.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Life expectancy of at least 12 weeks.\n* Acceptable laboratory values, and heart function.\n* Continuing side effects of prior treatment are mild\n* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.\n\nExclusion Criteria:\n\n* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).\n* Known involvement of central nervous system (CNS) by the disease under investigation.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.\n* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose\n* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.",{"count":54,"type":21},130,[56],"PHASE1","CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.\n\nParticipants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.",[59,60,61,62,63,64,65,66],"Leukemia, Acute Myeloid","Myelodysplastic Syndromes","Classical Hodgkin Lymphoma","Leukemia, B-cell","Leukemia, Hairy Cell","Mastocytosis, Aggressive Systemic","Blastic Plasmacytoid Dendritic Cell Neoplasm","Chronic Myeloid Leukemia","RECRUITING","2026-05-20",{"date":70,"type":37},"2026-05-22",{"date":72,"type":37},"2022-07-13",{"date":74,"type":21},"2027-05",{"name":76,"class":77},"MacroGenics","INDUSTRY",7,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":103,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100632820","phase-1-phase-i-clinical-trial-of-thinkk-adoptive-immunotherapy-after-allogeneic-hematopoietic-transplantation-in-children-with-leukemia-or-neuroblastoma-100632820","NCT07518654","Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma","Phase I Clinical Trial of Therapeutic Inducers of Natural Killer Killing (ThINKK) Adoptive Immunotherapy: Feasibility, Safety and Pharmacodynamics in Children Undergoing Allogenic Hematopoietic Transplantation for Leukemia or Neuroblastoma","ThINKK-01","Inclusion Criteria:\n\n1. Between 2 and less than 13 years old at time of informed consent form signature.\n2. Diagnosis of acute leukemia or neuroblastoma.\n3. Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.\n4. Blood NK cell counts ≥ 100 x 10E+6 cells\u002FL at least once before eligibility confirmation.\n5. Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.\n6. Patient or legally acceptable representative has provided informed consent based on local regulations and\u002For guidelines prior to any study-specific activities\u002Fprocedures being initiated.\n\nExclusion Criteria:\n\n1. Current grade 3 or 4 acute GvHD (per MAGIC criteria).\n2. Relapse of primary malignancy, or any other active malignancy.\n\n   1. For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion.\n   2. For neuroblastoma, defined as a progressive disease.\n3. Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose \\>0.5 mg\u002Fkg\u002Fday). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg\u002Fkg\u002Fday with Sponsor-Investigator approval, with the expectation that the taper will continue.\n4. Ongoing systemic therapy with cyclosporine.\n5. Administration or planned administration of any prohibited treatment listed in ad hoc section.\n6. Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal.\n7. Direct bilirubin serum levels ≥3 times the ULN (unless due to Gilbert syndrome).\n8. Baseline estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73 m2, as determined using the Bedside Schwartz equation for \\\u003C 18 years of age.\n9. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated).\n10. O2 Sat saturation \\\u003C90% on room air by pulse oximetry.\n11. Uncontrolled life-threatening symptomatic infection(s).\n12. Blood pressure below the 5th percentile for age, sex, and height last 24 hours.\n13. Ongoing therapy with intravenous vasopressor agent.\n14. Any condition that, in the opinion of the Investigator, would compromise the safety of the patient, would prevent full participation in this study, or would interfere with the evaluation of any study endpoints.\n15. Pregnancy or breastfeeding or absence of highly effective methods of contraception for males and females of childbearing potential who engage in heterosexual intercourse","2 Years","12 Years",{"count":90,"type":21},12,[56],"A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.\n\nThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.",[94,95,96,97,98,27,99,100,101,102],"Leukaemia (Acute Lymphoblastic)","Leukaemia (Acute Myeloid)","Neuroblastoma","Neuroblastoma, Metastatic","Leukaemia, Lymphoblastic, Acute","Leukemia (Both ALL and AML)","Leukemia Acute Myeloid - AML","Hematopoetic Stem Cell Transplantation","Hematopoetic Stem Cell Transplant",[104,105,106,107],"Thinkk","NK cells","pdc","immunotherapy","2026-04-02",{"date":110,"type":37},"2026-04-08",{"date":112,"type":21},"2026-05-01",{"date":114,"type":21},"2029-05-01",{"name":116,"class":44},"Michel Duval",2]