[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelogenous-leukemia-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelogenous-leukemia-acute":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":25,"conditions":26,"keywords":38,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100605053","phase-2-radioimmunotherapy-conditioning-with-131i--apamistamab-for-allogeneic-transplant-in-relapserefractory-aml-100605053",false,"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).","ALL","18 Years",{"count":19,"type":20},306,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","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.",[27,28,29,30,31,32,33,34,35,36,37],"Acute Leukemia","Myeloid Leukemia","Acute Myelogenous Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Transplant-Related Disorder","Allogeneic Disease","Refractory AML",[30,39,40,41,42,43,37,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"Leukemia","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","NOT_YET_RECRUITING","2025-09-04",{"date":65,"type":66},"2025-09-10","ACTUAL",{"date":68,"type":20},"2026-01",{"date":70,"type":20},"2034-02",{"name":72,"class":73},"Actinium Pharmaceuticals","INDUSTRY"]