[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636491":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":85,"centralContacts":89,"locations":97,"responsibleParty":114,"collaborators":33,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":33,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":33,"maxAge":124,"enrollmentInfo":125,"targetDuration":33,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":141,"overallStatus":100,"whyStopped":33,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Patients with High-Risk Disease","EXPERIMENTAL","Participants in complete remission (CR; bone marrow blasts \\\u003C5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks.\n\nFor participants with AML\u002FMDS, MRD (Measurable\u002FMinimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).",[13,14,15,16,17,18,19,20,21,22],"Biological: Cord Blood Units","Radiation: Total Body Irradiation","Drug: Cyclophosphamide","Drug: Fludarabine","Drug: Clofarabine","Drug: Busulfan","Drug: Thiotepa","Drug: Tacrolimus","Drug: Mycophenolate Mofetil","Drug: Cyclosporine",{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 2: Patients with Very High-Risk Disease","1. Participants in CR (bone marrow blasts \\\u003C5% by morphology) who had prior allogeneic transplant and disease recurrence.\n\n   1. Participants with AML\u002FMDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry)\n   2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry).\n   3. The second transplant will take place at least 4 months after the first.\n2. Participants with relapsed\u002Frefractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.",[13,14,15,16,17,18,19,20,21,22],[28,34,41,49,55,61,67,73,77,81],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","Cord Blood Units","Cord Blood \\[(HPC(CB)\\] products are minimally manipulated unrelated allogeneic cord blood units that have been collected, processed and stored in public Cord Blood banks",[9,24],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"RADIATION","Total Body Irradiation","Hyper-fractionated TBI is administered by a linear accelerator at a dose rate of \\\u003C20 cGy\u002Fminute. Treatment planning begins with simulation.",[9,24],[40],"TBI",{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Cyclophosphamide","Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis.",[9,24],[47,48],"Cytoxan","Neosar",{"type":42,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Fludarabine","Fludarabine phosphate is rapidly dephosphorylated to 2- fluoro-ara- A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2- fluoro-ara-ATP",[9,24],[54],"Fludara",{"type":42,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Clofarabine","Clofarabine, a purine (deoxyadenosine) nucleoside analog, is metabolized to clofarabine 5'-triphosphate.",[9,24],[60],"Clolar",{"type":42,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Busulfan","Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate.",[9,24],[66],"Busulfex",{"type":42,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Thiotepa","Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.",[9,24],[72],"Thioplex",{"type":42,"name":74,"description":75,"armGroupLabels":76,"otherNames":33},"Tacrolimus","Tacrolimus inhibits T-lymphocyte activation",[9,24],{"type":42,"name":78,"description":79,"armGroupLabels":80,"otherNames":33},"Mycophenolate Mofetil","Mycophenolate exhibits a cytostatic effect on T and B lymphocytes.",[9,24],{"type":42,"name":82,"description":83,"armGroupLabels":84,"otherNames":33},"Cyclosporine","Cyclosporine is a calcineurin inhibitor that inhibits production and release of interleukin II and inhibits interleukin II-induced activation of resting T-lymphocytes.",[9,24],[86],{"name":87,"affiliation":5,"role":88},"Andromachi Scaradavou, MD","PRINCIPAL_INVESTIGATOR",[90,94],{"name":87,"role":91,"phone":92,"phoneExt":33,"email":93},"CONTACT","833-MSK-KIDS","ScaradaA@mskcc.org",{"name":95,"role":91,"phone":92,"phoneExt":33,"email":96},"Jaap Jan Boelens, MD, PhD","boelensj@mskcc.org",[98],{"facility":99,"status":100,"city":101,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","RECRUITING","New York","10065","United States","US",{"type":106,"coordinates":107},"Point",[108,109],-74.00597,40.71427,{"lat":109,"lon":108},[112],{"name":87,"role":91,"phone":113,"phoneExt":33,"email":33},"1-833-MSK-KIDS",{"type":115,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100636491","phase-2-cord-blood-transplantation-in-children-and-young-adults-with-blood-cancer-100636491",false,"NCT07566377","Cord Blood Transplantation in Children and Young Adults With Blood Cancer","Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met.\n\n° Disease type\n\nCohort 1, High Risk Disease: Patients with age ≤ 26 years at the time of informed consent with no available and suitably matched related or unrelated donor within 4 weeks, with one of the following diagnoses:\n\nI. Acute myelogenous leukemia (AML):\n\n* Complete first remission (CR1) with blast count \\\u003C 5% by bone marrow morphology at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS)\n  * High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and\u002For high-risk molecular abnormalities (e.g., TP53)\n  * Requirement for 2 or more inductions to achieve CR1\n  * Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and\u002For gene therapy or cell therapy)\n  * Presence of Minimal\u002FMeasurable Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods (at End of Induction or End of Consolidation)\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or subsequent remission, with blast count \\\u003C 5% by bone marrow morphology\n* Presence of MRD by multiparameter flow cytometry at pre-transplant evaluation is acceptable.\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) with MRD negative status by multicolor flow cytometry, 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, KMT2A (11q23) or other high risk molecular abnormality\n  * Failure to achieve complete remission (CR) after four weeks of induction therapy (transplant to follow antibody therapy and\u002For CAR T cells)\n  * Persistence or recurrence of MRD on therapy (Transplant to follow antibody therapy and\u002For CAR T cells)\n  * T-ALL in CR even with presence of MRD\n  * Other high-risk features not defined above\n* Complete second remission (CR2) or subsequent remission with MRD negative status by multiparameter flow cytometry.\n\n  * Relapse in less than 36 months from CR1\n  * Relapse for T-ALL\n* Patients after antibody therapy (e.g., blinatumomab, inotuzumab, other) and\u002For CAR-T cell therapy that resulted in MRD negative status by multiparameter flow cytometry.\n\nIII. Other acute leukemias:\n\n* Leukemias of ambiguous lineage or of other types with \\\u003C 5% blasts by bone marrow morphology.\n* Patients with persistent\u002Frelapsed disease with cytogenetic, flow cytometric or molecular aberrations in \\\u003C 5% of cells.\n* Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase.\n* Any leukemia that developed after gene therapy or cell therapy\n\nIV. Myelodysplastic Syndrome (MDS):\n\n* Any IPSS risk category with life-threatening cytopenia(s).\n* Any IPSS risk category with high risk cytogenetic\u002Fmolecular findings (5, 7, 8, complex karyotype, or TP53)\n\nV. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high risk of relapse or progression if not in remission:\n\n* Patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell NHL) in CR.\n* 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 stable disease\u002F CR\u002F PR with no single lesion equal to or more than 5 cm.\n* Patients with HL without progression of disease (POD) after salvage chemotherapy with no single lesion ≥5 cm.\n\nCohort 2: Very High-Risk disease:\n\n1. Patients in CR (bone marrow blasts \\\u003C5% by morphology) who had prior allogeneic transplant and disease recurrence. The second transplant will take place at least 4 months after the first.\n\n   * Acute myelogenous leukemia (AML) or Myelodysplastic Syndrome (MDS): Relapse after previous transplant, in CR after induction therapy. MRD positive status by multi-parameter flow cytometry is accepted.\n   * Acute lymphoblastic leukemia (ALL): Relapse after previous transplant, in CR after induction therapy and\u002For antibody therapy\u002FCAR T cells. MRD positive status after targeted therapy, as evaluated by multi-parameter flow cytometry is accepted.\n   * Other: patients with leukemia or lymphoma, who, in the opinion of their physician, are not likely to have reduction in disease burden with further chemotherapy.\n2. Patients with relapsed\u002Frefractory disease at either first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology. ° Relapse after previous transplant with \\\u003C 30% blasts by bone marrow morphology, or with cytogenetic, flow cytometric, or molecular abnormalities in \\\u003C 30% of bone marrow cells, after induction therapy.\n\n   ° Primary refractory or relapsed AML with \\\u003C 30% blasts by bone marrow morphology or with cytogenetic, flow cytometric, or molecular abnormalities in \\\u003C 30% of bone marrow cells.\n\n   ° Age 0-26 years at the time of informed consent\n\n   ° Performance: Karnofsky (≥16 years) or Lansky score (\\\u003C16 years) of ≥70% (see Appendix A).\n\n   ° Not Pregnant and Not Nursing\n\n   ° Required Organ Function\n   * Bilirubin ≤ 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia).\n   * ALT ≤ 3 x upper limit of normal.\n   * Pulmonary function (FVC, FEV1 and DLCO corrected for hemoglobin) ≥ 50% predicted.\n\n     * In young children unable to perform pulmonary function testing: pulse oximetry \\>92% in room air, and a normal CT of the chest (if CT is not normal, the child needs to be evaluated and cleared by pediatric pulmonary physician).\n   * Left ventricular ejection fraction \\> 50%.\n   * Age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) ≤ 7.\n   * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study.\n   * Renal: Serum creatinine (SCr) ≤ 1.5 x normal for age. If SCr is outside the normal range, then CrCl \\> 50 mL\u002Fmin (calculated or estimated) or estimated GFR (mL\u002Fmin\u002F1.73m2) \\>30% of predicted normal for age.\n\n   Normal GFR by Age : Mean GFR +- SD (mL\u002Fmin\u002F1.73m\\^2) 1 week : 40.6 + \u002F - 14.8 2-8 weeks : 65.8 + \u002F - 24.8 \\>8 weeks : 95.7 + \u002F - 21.7 2-12 years : 133.0 + \u002F - 27.0 13-21 years (males) : 140.0 + \u002F - 30.0 13-21 years (females) : 126.0 + \u002F - 22.0\n\n   GFR, glomerular filtration rate; SD, standard deviation; Greater than 2 years old: Normal GFR is 100 mL\u002F min; Infants: GFR must be corrected for body surface area.\n\n   Exclusion Criteria:\n\n   Exclusion criteria for both cohorts:\n\n   ° Inadequate performance status\u002F organ function.\n\n   ° Active CNS leukemic involvement.\n   * Chloroma \\>2 cm.\n   * Active and uncontrolled infection (bacterial\u002Ffungal\u002Fviral) at time of transplant.\n   * HIV infection.\n   * Seropositivity for HTLV-1.\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.\n   * Any abnormal condition or lab result that is considered by the PI capable or altering patient's condition or study outcome.\n\n   Cohort 2 Very High-Risk Disease (additional to above):\n\n   ° Allogeneic HCT in the preceding 4 months.\n\n   Note (1): Prior checkpoint inhibitors\u002Fblockade in the last 12 months: eligibility to be discussed with study PI.\n\n   Note (2): For patients with known HBV and\u002For HCV infection :\n   * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n   * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.","ALL","26 Years",{"count":126,"type":127},71,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","The purpose of this study is to find out whether Cord Blood Transplantation\u002FCBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.",[133,134,135,136,137,138,139,140],"Acute Myelogenous Leukemia","Acute Lymphoblastic Leukemia","Myelodysplastic Syndromes","Non-hodgkin Lymphoma","Hodgkin Lymphoma","Leukemia","Lymphoma","Graft-versus-host Disease",[142,140,139,138,137,136,135,134,133,5,143],"Cord blood transplants","26-168","2026-05-11",{"date":146,"type":147},"2026-05-14","ACTUAL",{"date":149,"type":147},"2026-04-28",{"date":151,"type":127},"2030-04-28",{"name":5,"class":6},1]