{ "data": { "asOf": "2026-10-30T22:26:13.039Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06013423", "title": "Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases", "scientificTitle": "Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Acute Leukemia of Ambiguous Lineage", "Acute Lymphoblastic Leukemia", "Acute Myeloid Leukemia", "Blastic Plasmacytoid Dendritic Cell Neoplasm", "Hematopoietic and Lymphatic System Neoplasm", "Mixed Phenotype Acute Leukemia", "Myelodysplastic Syndrome", "Myeloproliferative Neoplasm", "Non-Hodgkin Lymphoma", "Chronic Myeloid Leukemia, BCR-ABL1 Positive" ], "interventions": [ { "name": "Biospecimen Collection", "type": "PROCEDURE", "description": "Undergo blood sample collection" }, { "name": "Bone Marrow Aspirate", "type": "PROCEDURE", "description": "Undergo bone marrow aspirate" }, { "name": "Cyclophosphamide", "type": "DRUG", "description": "Given IV" }, { "name": "Cyclosporine", "type": "DRUG", "description": "Given IV or PO" }, { "name": "Diagnostic Imaging Testing", "type": "PROCEDURE", "description": "Undergo diagnostic imaging" }, { "name": "Echocardiography Test", "type": "PROCEDURE", "description": "Undergo ECHO" }, { "name": "Fludarabine Phosphate", "type": "DRUG", "description": "Given IV" }, { "name": "Multigated Acquisition Scan", "type": "PROCEDURE", "description": "Undergo MUGA" }, { "name": "Mycophenolate Mofetil", "type": "DRUG", "description": "Given IV" }, { "name": "Survey Administration", "type": "OTHER", "description": "Ancillary studies" }, { "name": "Thiotepa", "type": "DRUG", "description": "Given IV" }, { "name": "Total-Body Irradiation", "type": "RADIATION", "description": "Undergo high-dose or middle-intensity TBI" }, { "name": "Umbilical Cord Blood Transplantation", "type": "PROCEDURE", "description": "Undergo UCBT" } ], "sponsor": { "name": "Fred Hutchinson Cancer Center", "type": "OTHER" }, "locations": [ { "city": "Seattle", "country": "United States", "facility": "Fred Hutch/University of Washington Cancer Consortium" } ], "outcomes": { "other": [], "primary": [ "Overall survival" ], "secondary": [ "Cumulative incidence of neutrophil and platelet engraftment", "Incidences of graft failure", "Incidence of grade II-IV and III-IV acute graft-versus-host disease (aGVHD)", "Incidence of grade II-IV and III-IV aGVHD", "Incidence of chronic graft-versus-host disease (cGVHD)", "Organ distribution of GVHD", "Incidence of adverse events", "Time to immunosuppression cessation", "Pattern of donor chimerism", "Incidence of pre-engraftment syndrome (PES)", "Incidence of transplant related mortality (TRM)", "Incidence of relapse" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Patients aged 6 months to =\\< 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\< 5% marrow blasts at the time of transplant.\n * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n * Failure to achieve MRD- complete remission after induction therapy.\n * Persistence or recurrence of minimal residual disease on therapy.\n * Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n * Other high-risk features not defined above.\n * Complete second remission (CR2) or greater (CR2+).\n\n * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n * MDS/MPD overlap syndromes without myelofibrosis.\n * MDS/ MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET/CT imaging.\n * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET/CT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg/m\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 16 years old, Karnofsky score ≥ 70%. For patients =\\< 16 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml/min.\n* Bilirubin \\< 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\< 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\< 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g/dL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\< 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors/ blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status/ organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.", "maximumAge": "65 Years", "minimumAge": "6 Months", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 54 }, "startDate": "2024-07-23", "completionDate": "2032-10-31", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2023-08-28T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06013423" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06013423", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06013423", "sourceUrl": "https://clinicaltrials.gov/study/NCT06013423", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-27T04:32:55.488Z", "payloadSha256": "e623164fc2259afe41550b26aa188e04fdc9e1fa22c2ac96c4c9bf7eb59c6dd8", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06013423", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06013423", "verifyAt": "https://clinicaltrials.gov/study/NCT06013423", "retrievedAt": "2026-10-27T04:32:55.488Z", "payloadSha256": "e623164fc2259afe41550b26aa188e04fdc9e1fa22c2ac96c4c9bf7eb59c6dd8", "text": "ClinicalTrials.gov, record NCT06013423 (https://clinicaltrials.gov/study/NCT06013423), retrieved 2026-10-27, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06013423, registered in ClinicalTrials.gov, retrieved 2026-10-27. 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