[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100264904":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":200,"centralContacts":204,"locations":209,"responsibleParty":226,"collaborators":228,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":138,"eligibilityCriteria":237,"healthyVolunteers":234,"sex":238,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":138,"studyType":244,"phases":245,"briefSummary":247,"conditions":248,"keywords":138,"overallStatus":212,"whyStopped":138,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Myeloablative regimen 1","EXPERIMENTAL","Patients receive anti-thymocyte globulin IV over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo TBI on day -3.\n\nUMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0.\n\nNK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.",[13,14,15,16,17,18,19,20],"Biological: Allogeneic Natural Killer Cell Line NK-92","Biological: Anti-Thymocyte Globulin","Drug: Busulfan","Drug: Clofarabine","Drug: Fludarabine Phosphate","Other: Laboratory Biomarker Analysis","Radiation: Total-Body Irradiation","Procedure: Umbilical Cord Blood Transplantation",{"label":22,"type":10,"description":23,"interventionNames":24},"Non-myeloablative regimen 2","Patients with CD20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s).\n\nUMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0.\n\nNK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.",[13,14,25,17,18,26,19,20],"Drug: Cyclophosphamide","Biological: Rituximab",{"label":28,"type":10,"description":29,"interventionNames":30},"Reduced intensity regimen 3","Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2.\n\nUMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0.\n\nNK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.",[13,14,17,18,31,20],"Drug: Melphalan",[33,42,50,82,88,125,134,139,156,184,192],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BIOLOGICAL","Allogeneic Natural Killer Cell Line NK-92","Given IV",[9,22,28],[39,40,41],"haNK","NK-92","NK-92 Cells",{"type":34,"name":43,"description":36,"armGroupLabels":44,"otherNames":45},"Anti-Thymocyte Globulin",[9,22,28],[46,47,48,49],"Antithymocyte Globulin","Antithymocyte Serum","ATG","ATS",{"type":51,"name":52,"description":36,"armGroupLabels":53,"otherNames":54},"DRUG","Busulfan",[9],[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"1, 4-Bis[methanesulfonoxy]butane","BUS","Bussulfam","Busulfanum","Busulfex","Busulphan","CB 2041","CB-2041","Glyzophrol","GT 41","GT-41","Joacamine","Methanesulfonic Acid Tetramethylene Ester","Methanesulfonic acid, tetramethylene ester","Mielucin","Misulban","Misulfan","Mitosan","Myeleukon","Myeloleukon","Myelosan","Mylecytan","Myleran","Sulfabutin","Tetramethylene Bis(methanesulfonate)","Tetramethylene bis[methanesulfonate]","WR-19508",{"type":51,"name":83,"description":36,"armGroupLabels":84,"otherNames":85},"Clofarabine",[9],[86,87],"Clofarex","Clolar",{"type":51,"name":89,"description":36,"armGroupLabels":90,"otherNames":91},"Cyclophosphamide",[22],[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719",{"type":51,"name":126,"description":36,"armGroupLabels":127,"otherNames":128},"Fludarabine Phosphate",[9,22,28],[129,130,131,132,133],"2-F-ara-AMP","9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-","Beneflur","Fludara","SH T 586",{"type":6,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Laboratory Biomarker Analysis","Correlative studies",[9,22,28],null,{"type":51,"name":140,"description":36,"armGroupLabels":141,"otherNames":142},"Melphalan",[28],[143,144,145,146,147,148,149,150,151,152,153,154,155],"Alanine Nitrogen Mustard","CB-3025","L-PAM","L-Phenylalanine Mustard","L-sarcolysin","L-Sarcolysin Phenylalanine mustard","L-Sarcolysine","Melphalanum","Phenylalanine Mustard","Phenylalanine nitrogen mustard","Sarcoclorin","Sarkolysin","WR-19813",{"type":34,"name":157,"description":36,"armGroupLabels":158,"otherNames":159},"Rituximab",[22],[160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183],"ABP 798","BI 695500","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT-P10","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","MabThera","Monoclonal Antibody IDEC-C2B8","PF-05280586","Rituxan","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar IBI301","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","rituximab biosimilar TQB2303","rituximab-abbs","RTXM83","Truxima",{"type":185,"name":186,"description":187,"armGroupLabels":188,"otherNames":189},"RADIATION","Total-Body Irradiation","Undergo total body irradiation",[9,22],[190,191],"Total Body Irradiation","Whole-Body Irradiation",{"type":193,"name":194,"description":195,"armGroupLabels":196,"otherNames":197},"PROCEDURE","Umbilical Cord Blood Transplantation","Undergo umbilical cord blood transplantation",[9,22,28],[198,199],"Cord Blood Transplantation","UCB transplantation",[201],{"name":202,"affiliation":5,"role":203},"Warren Fingrut, MD","PRINCIPAL_INVESTIGATOR",[205],{"name":206,"role":207,"phone":138,"phoneExt":138,"email":208},"Warren B Fingrut, MD","CONTACT","WBFingrut@mdanderson.org",[210],{"facility":211,"status":212,"city":213,"state":214,"zip":215,"country":216,"countryCode":217,"cosmosGeoPoint":218,"geoPoint":223,"contacts":224},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":219,"coordinates":220},"Point",[221,222],-95.36327,29.76328,{"lat":222,"lon":221},[225],{"name":206,"role":203,"phone":138,"phoneExt":138,"email":138},{"type":227,"investigatorFullName":138,"investigatorTitle":138,"investigatorAffiliation":138,"oldNameTitle":138,"oldOrganization":138},"SPONSOR",[229],{"name":230,"class":231},"National Cancer Institute (NCI)","NIH","100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904",false,"NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","ALL","15 Years","80 Years",{"count":242,"type":243},100,"ESTIMATED","INTERVENTIONAL",[246],"PHASE2","This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Myelomonocytic Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","2026-05-20",{"date":277,"type":278},"2026-05-22","ACTUAL",{"date":280,"type":278},"2016-05-19",{"date":282,"type":243},"2027-05-31",{"name":5,"class":6},1]