[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml-childhood\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml-childhood":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,77,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100528289","phase-1-pilot-study-of-memory-like-natural-killer-ml-nk-cells-after-tcr-t-cell-depleted-haploidentical-transplant-in-aml-100528289",false,"NCT06158828","Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML","A Phase I\u002FII Pilot Study of Memory-like NK Cells to Consolidate TCRαβ T Cell Depleted Haploidentical Transplant in High-risk AML","ABCD-NK","Patient Inclusion Criteria - Cohort 1:\n\n1. High risk acute myeloid leukemia (AML) in either:\n\n   1. Complete remission (CR) defined by \\\u003C 5% marrow blasts by morphology in the context of hematological recovery (ANC ≥ 0.5× 10\\^9\u002FL, platelet count ≥ 50 × 10\\^9\u002FL).\n   2. Morphological leukemia free state (MLFS) defined by the absence of hematological recovery and \\\u003C 5% marrow blasts by morphology\n2. Patients must further meet one of the below for inclusion into the study:\n\n   1. De novo AML in CR1 with any of the following high-risk features:\n\n      * MRD ≥ 1% after first induction course\n      * MRD ≥ 0.1% after second induction course\n      * RPN1-MECOM\n      * RUNX1-MECOM\n      * NPM1-MLF1\n      * DEK-NUP214\n      * KAT6A-CREBBP (if ≥ 90 days at diagnosis)\n      * FUS-ERG\n      * KMT2A-AFF1\n      * KMT2A-AFDN\n      * KMT2A-ABI1\n      * KMT2A-MLLT1\n      * 11p15 rearrangement (NUP98 - any partner gene)\n      * 12p13.2 rearrangement (ETV6 - any partner gene)\n      * Deletion 12p to include 12p13.2 (loss of ETV6)\n      * Monosomy 5\u002FDel(5q) to include 5q31 (loss of EGR1)\n      * Monosomy 7\n      * 10p12.3 rearrangement (MLLT10b - any partner gene)\n      * FLT3\u002FITD with allelic ratio \\> 0.1%, without bZIP CEBPA or NPM1\n      * RAM phenotype as evidenced by flow cytometry\n      * Other high-risk features not explicitly stated here, after discussion\u002Fapproval with protocol PI.\n   2. De novo AML in ≥ CR2\n   3. Therapy-related AML in CR1\n   4. AML evolving from myelodysplastic syndrome (MDS)\n3. One prior hematopoietic cell transplant is allowed, provided remission criteria as defined above are met.\n\nPatient Inclusion Criteria - Cohort 2:\n\n1. High risk acute myeloid leukemia (AML) defined by either of the following:\n\n   1. Treatment refractory disease: AML that is not in complete remission despite prior standard or salvage therapies.\n   2. Multiply relapsed disease: AML that has relapsed after 2 or more hematopoietic cell transplantations.\n2. BM disease burden: Less than 25% bone marrow blasts by morphology must be present (M2 marrow), irrespective of peripheral hematological recovery.\n\nPatient Inclusion Criteria - Both Cohorts:\n\n1. Less than or equal to 40 years of age.\n2. Lansky (\\\u003C16 years) or Karnofsky (≥16 years) performance status of \\>60%.\n3. Adequate organ function as defined below:\n\n   1. Total bilirubin ≤ 3 x IULN for age\n   2. AST(SGOT)\u002FALT(SGPT) ≤ 5 x IULN for age\n   3. GFR ≥ 60 mL\u002Fmin\u002F1.73m2 as estimated by (1) updated Schwartz formula for ages 1-17 years or Cockcroft-Gault formula for ages ≥ 18 years, (2) 24-hour creatinine clearance, or (3) renal scintigraphy. If GFR is abnormal for age based on updated Schwartz or Cockcroft-Gault formula, accurate measurement should be obtained by either 24-hour creatinine clearance or renal scintigraphy.\n   4. Renal function may also be estimated by serum creatinine based on age\u002Fgender. A serum creatinine \\\u003C 2 x IULN for age\u002Fgender is required for inclusion on this protocol.\n4. Adequate cardiac function, defined by left ventricular ejection fraction (LVEF) at rest ≥50% or shortening fraction (SF) ≥27% (via echocardiogram or MUGA).\n5. Adequate pulmonary function, defined by:\n\n   1. FEV1, FVC, and DLCO ≥50% of predicted.\n   2. O2 saturation ≥ 92% on room air by pulse oximetry and no supplemental O2 at rest for children \\\u003C 8 years of age or those unable to perform pulmonary function testing (PFT). For children unable to perform PFT, a high-resolution CT chest should be obtained.\n6. The effects of these treatments on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 24 months following transplant. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n7. Ability to understand and willingness to sign an IRB approved written informed consent document, or patient has a guardian who has the ability to understand and willingness to sign an IRB approved written informed consent document.\n8. Available familial haploidentical donor. The HCT donor must be available and willing to undergo 2 leukapheresis procedures: (I) one mobilized collection for the HPC graft and (II) one non-mobilized leukapheresis collection for the manufacturing of ML NK cells.\n9. Donor and recipient must be identical at a minimum of one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA- DQB1. A minimum of 5\u002F10 match is required and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.\n\nPatient Exclusion Criteria - Both Cohorts\n\n1. Active GvHD. If patient had prior GvHD, patient must be off immunosuppression for at least 3 months prior to starting study treatment.\n2. Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been completed and there is no current evidence of disease.\n3. Currently receiving any other investigational agents at the time of transplant.\n4. Active CNS or extramedullary disease. History of CNS or extramedullary disease currently in remission is acceptable.\n5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.\n6. Inability to discontinue medications that are likely to interfere with ML NK cell activity, i.e., glucocorticoids and other immunosuppressants.\n7. Presence of significant anti-donor HLA antibodies per institutional standards. Anti-donor HLA - Antibody Testing is defined as a positive crossmatch test of any titer (by complement dependent cytotoxicity or flow cytometric testing) or the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay \\> 3000.\n8. Presence of a second major disorder deemed a contraindication for HCT.\n9. Patients with Fanconi Anemia or Down Syndrome.\n10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, viral with clinical instability, or fungal), symptomatic congestive heart failure, or unstable cardiac arrhythmia.\n11. Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of the start of conditioning.\n\nDonor Eligibility Criteria - Both Cohorts\n\n1. The preferred donor should be an adult aged 18 years or older. However, in circumstances where no suitable adult donor is available, consideration may be given to a minor donor aged 12 years or older. This exception only applies when all identified, otherwise eligible adult donors meet one or more of the following criteria:\n\n   * A medical condition that poses unacceptable risk, including autoimmune disease, infection, hematologic disorder, malignancy or a pathogenic germline mutation.\n   * Comorbidities that preclude safe administration of granulocyte colony-stimulating factor (G-CSF), placement of a pheresis catheter and\u002For stem cell collection.\n   * Served as donor in prior haploidentical HCT.\n   * Significant psychosocial or logistical barriers.\n2. Donor must be HLA haploidentical (≥ 5\u002F10 and ≤ 9\u002F10 allele match at the -A, -B, -C, DRB1 and DQ loci) by high resolution typing and related to the patient.\n3. Donor must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT).\n4. Donor must be available and willing to undergo one mobilized and one non-mobilized leukapheresis procedure.\n5. Donor may not be pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of recipient's conditioning regimen, within 7 days of donor stem cell mobilization regimen and prior to second non-mobilized leukapheresis..\n6. Donor must be able to understand and willing to sign an IRB-approved written informed consent document.","ALL","18 Years",{"count":20,"type":21},68,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This trial represents a single institution phase I\u002FII pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.",[28,29,30,31],"AML, Childhood","Aml","Acute Myeloid Leukemia, Pediatric","Acute Myeloid Leukemia",[33,34,35,36,37,38],"high-risk AML","haploidentical transplant","high-risk acute myeloid leukemia","AML from MDS","memory-like natural killer cells","ML NK cells","RECRUITING","2026-04-29",{"date":42,"type":43},"2026-05-05","ACTUAL",{"date":45,"type":43},"2024-11-15",{"date":47,"type":21},"2030-05-31",{"name":49,"class":50},"Washington University School of Medicine","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":51},"100541177","phase-1-car-t-cell-therapy-directed-to-cd70-for-pediatric-patients-with-hematological-malignancies-100541177","NCT06326463","CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies","Inclusion Criteria\n\nAge ≤21 years old\n\nRelapsed\u002Frefractory CD70+ hematological malignancy\n\nRelapsed disease: Patients developing recurrent disease after a prior complete remission (CR)\n\nRefractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy.\n\n* Relapsed\u002Frefractory CD70+ AML or MDS:\n\n  * Relapsed disease that is CD70 positive\n  * Refractory disease that is persistent despite 3 cycles of chemotherapy\n* Relapsed\u002Frefractory CD70+ B-cell ALL:\n\n  * Relapsed disease that is CD70 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19-directed therapies including:\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n* Relapsed\u002Frefractory CD70+ T-cell ALL:\n\n  * Relapsed \u002Frefractory disease that is CD70 positive\n* Mixed Phenotype Acute Leukemia (MPAL):\n\n  * Relapsed\u002Frefractory that is CD70 positive\n* Relapsed\u002Frefractory CD70+ lymphoma:\n\n  * Relapsed disease that is CD70 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19-directed therapies including:\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n\nEstimated life expectancy of \\>12 weeks\n\nKarnofsky or Lansky (age- dependent) performance score ≥50\n\nPatients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis\n\nPatient must have an identified HCT donor\n\nFor females of childbearing age:\n\ni. Not lactating with intent to breastfeed\n\nii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment\n\nExclusion Criteria\n\n* Known primary immunodeficiency\n* Known history of HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity to cornstarch or hydroxyethyl starch\n* Patients with acute promyelocytic leukemia (APL)\n* Known contraindication to protocol defined lymphodepleting\n* chemotherapy regimen of Fludarabine\u002Fcyclophosphamide","21 Years",{"count":60,"type":21},18,[24],"The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)\u002Fmyelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).\n\nPrimary Objective\n\nTo determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD70+ hematological malignancies after lymphodepleting chemotherapy.\n\nSecondary Objectives\n\nTo evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease.",[64,65,28,66,67],"Hematologic Malignancy","ALL, Childhood","Lymphoma","MDS","2026-01-22",{"date":70,"type":43},"2026-01-23",{"date":72,"type":43},"2024-10-16",{"date":74,"type":21},"2031-07-01",{"name":76,"class":50},"St. Jude Children's Research Hospital",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100540447","phase-2-safety-and-efficacy-of-avapritinib-in-relapsed-or-refractory-pediatric-cbf-aml-with-kit-mutation-100540447","NCT06316960","Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation","A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed\u002FRefractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation","Inclusion Criteria:\n\n1. Gender unlimited;\n2. Under 18 years;\n3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).\n4. Presence of t(8;21)\u002FRUNX1::RUNX1T1 or inv(16)\u002Ft(16;16)\u002FCBFβ::MYH11;\n5. KIT mutation;\n6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;\n7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;\n8. No active infections;\n9. Liver function: Tbil ≤2×ULN, ALT\u002FAST ≤3×ULN, creatinine clearance ≥50ml\u002Fmin;\n10. ECOG score \\\u003C2;\n11. Expected survival time \\>12 weeks;\n12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Have received prior treatment with avapritinib;\n2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;\n3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);\n4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；\n5. With other malignancies requiring treatment；\n6. Already enrolled in another interventional clinical study；\n7. The researchers determined that the individual is not suitable to participate in this trial.",{"count":85,"type":21},50,[25],"The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.",[28,89,90,91,92],"Relapse\u002FRecurrence","Refractory AML","Core Binding Factor Acute Myeloid Leukemia","C-KIT Mutation",[94,95,96,97,98],"Avapritinib","KIT","CBF AML","Childhood","Relapsed\u002FRefractory","2024-08-21",{"date":101,"type":43},"2024-08-22",{"date":103,"type":43},"2024-03-01",{"date":105,"type":21},"2027-03",{"name":107,"class":50},"Children's Hospital of Soochow University",12,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100533120","phase-2-clinical-study-of-induction-therapy-options-based-on-molecular-subtyping-and-mrd-in-children-and-adolescents-with-aml-100533120","NCT06221683","Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML","A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML: A Phase II Cohort Study (GMCAII)","GMCAII","Inclusion Criteria:\n\n* 1、Newly diagnosed, untreated AML；\n* 2、Under 18 years old;\n* 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg\u002Fm2 (50 mg\u002Fm2, q12h × 5d)；\n* 4、 Liver function：Tbil≤2×ULN, ALT\u002FAST≤3×ULN, creatinine clearance ≥50ml\u002Fmin；Cardiac NYHA grading\\\u003C3；SaO2\\>92%;\n* 5、No active infection (symptoms resolved for more than 3 days if infected)\n* 6、ECOG\\\u003C2;\n* 7、Expected survival time greater than 12 weeks;\n* 9、Obtain the consent of the child and\u002For guardian and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1、Acute megakaryocytic leukemia (AMKL)；\n* 2、Acute promyelocytic leukemia (APL);\n* 3、Treatment-related secondary AML and AML with definite MDS transformation；\n* 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);\n* 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；\n* 6、AML secondary to Down syndrome;\n* 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan;\n* 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol;\n* 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria；\n* 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;\n* 11、Relapsed AML at any time；\n* 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors.",{"count":118,"type":21},500,[25],"The goal of this clinical trial is to estimate the rate (probability) of complete remission or complete remission with incomplete count recovery (CR\u002FCRi) with negative MRD after induction I and II, event-free survival (EFS), and cumulative incidence (probability) of relapse (CIR), in patients receiving molecular\u002Fprecision medicine and MRD-driven remission inductions, and to assess secondarily if there is an improvement over the AML2018 protocol.",[28,31],[123,97,124,125],"AML","Molecular subtyping","MRD",{"date":101,"type":43},{"date":128,"type":43},"2024-01-01",{"date":130,"type":21},"2029-12",{"name":107,"class":50},13]