Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-25 @ 5:23 PM
Study NCT ID:
NCT02727803
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2016-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized NK Cell Therapy in CBT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015465', 'term': 'Leukemia, Myeloid, Accelerated Phase'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D000077866', 'term': 'Clofarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C000626854', 'term': 'CT-P10'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D036101', 'term': 'Cord Blood Stem Cell Transplantation'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) time in C2C2 patients', 'timeFrame': 'From the date of engraftment to disease progression or death, assessed up to 4 years', 'description': 'Distributions of time-to-event variables will be estimated using the method of Kaplan and Meier, and Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, human leukocyte antigen (HLA) match, cytomegalovirus (CMV) status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}, {'measure': 'Progression free survival (PFS) time in C1 patients', 'timeFrame': 'From the date of cord blood transplant to disease progression or death, assessed up to 4 years', 'description': 'Distributions of time-to-event variables will be estimated using the method of Kaplan and Meier, and Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}], 'secondaryOutcomes': [{'measure': 'Overall survival time', 'timeFrame': 'Up to 4 years', 'description': 'Distributions of time-to-event variables will be estimated using the method of Kaplan and Meier, and Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}, {'measure': 'Incidence of transplant related mortality', 'timeFrame': 'Up to 4 years', 'description': 'Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}, {'measure': 'Incidence of graft-versus host disease', 'timeFrame': 'Up to 4 years', 'description': 'Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}, {'measure': 'Incidence of infection', 'timeFrame': 'Up to 4 years', 'description': 'Bayesian regression models will be used to assess the relationship of each outcome with patient covariates, including disease stage, KIR haplotype, age, diagnosis, HLA match, CMV status, and gender. Categorical outcomes will be evaluated by tabulation and Bayesian regression modeling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['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/Myeloproliferative 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']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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/x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2/C2 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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Progression-free survival (PFS) time.\n\nSECONDARY OBJECTIVES:\n\nI. Overall survival (OS) time. II. Transplant related mortality (TRM). III. Graft versus host disease (GVHD). IV. Infection\n\nOUTLINE: Patients are assigned to 1 of 3 preparative regimens.\n\nMYELOABLATIVE REGIMEN 1: Patients receive anti-thymocyte globulin intravenously (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 total body irradiation (TBI) on day -3.\n\nNON-MYELOABLATIVE REGIMEN 2: Patients with cluster of differentiation (CD)20 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\nREDUCED 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.\n\nAfter completion of study treatment, patients are followed up at 1, 7, 14, 28, 45, 60, and 100 days, and at 6, 9, and 12 months, and then yearly for up to 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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\\], -5/5q-, -7/7q-, abn\\[12p\\], abn\\[17p\\], myeloid/lymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or 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/myeloproliferative syndromes, 8) complex karyotype, abn(3g), -5/5g-, -7/7g-, 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/or 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 =\\< 45 years (myeloablative regimen 1; age \\>= 15 and =\\< 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\< 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/min/1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)/bilirubin \\< to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT/bilirubin \\< 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"}, 'identificationModule': {'nctId': 'NCT02727803', 'briefTitle': 'Personalized NK Cell Therapy in CBT', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Personalized NK Cell Therapy in CBT', 'orgStudyIdInfo': {'id': '2015-0313'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00584', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2015-0313', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'R01CA211044', 'link': 'https://reporter.nih.gov/quickSearch/R01CA211044', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myeloablative regimen 1', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Non-myeloablative regimen 2', 'description': '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.', 'interventionNames': ['Biological: Allogeneic Natural Killer Cell Line NK-92', 'Biological: Anti-Thymocyte Globulin', 'Drug: Cyclophosphamide', 'Drug: Fludarabine Phosphate', 'Other: Laboratory Biomarker Analysis', 'Biological: Rituximab', 'Radiation: Total-Body Irradiation', 'Procedure: Umbilical Cord Blood Transplantation']}, {'type': 'EXPERIMENTAL', 'label': 'Reduced intensity regimen 3', 'description': '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.', 'interventionNames': ['Biological: Allogeneic Natural Killer Cell Line NK-92', 'Biological: Anti-Thymocyte Globulin', 'Drug: Fludarabine Phosphate', 'Other: Laboratory Biomarker Analysis', 'Drug: Melphalan', 'Procedure: Umbilical Cord Blood Transplantation']}], 'interventions': [{'name': 'Allogeneic Natural Killer Cell Line NK-92', 'type': 'BIOLOGICAL', 'otherNames': ['haNK', 'NK-92', 'NK-92 Cells'], 'description': 'Given IV', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2', 'Reduced intensity regimen 3']}, {'name': 'Anti-Thymocyte Globulin', 'type': 'BIOLOGICAL', 'otherNames': ['Antithymocyte Globulin', 'Antithymocyte Serum', 'ATG', 'ATS'], 'description': 'Given IV', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2', 'Reduced intensity regimen 3']}, {'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['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'], 'description': 'Given IV', 'armGroupLabels': ['Myeloablative regimen 1']}, {'name': 'Clofarabine', 'type': 'DRUG', 'otherNames': ['Clofarex', 'Clolar'], 'description': 'Given IV', 'armGroupLabels': ['Myeloablative regimen 1']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-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'], 'description': 'Given IV', 'armGroupLabels': ['Non-myeloablative regimen 2']}, {'name': 'Fludarabine Phosphate', 'type': 'DRUG', 'otherNames': ['2-F-ara-AMP', '9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-', 'Beneflur', 'Fludara', 'SH T 586'], 'description': 'Given IV', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2', 'Reduced intensity regimen 3']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2', 'Reduced intensity regimen 3']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['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'], 'description': 'Given IV', 'armGroupLabels': ['Reduced intensity regimen 3']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['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'], 'description': 'Given IV', 'armGroupLabels': ['Non-myeloablative regimen 2']}, {'name': 'Total-Body Irradiation', 'type': 'RADIATION', 'otherNames': ['Total Body Irradiation', 'Whole-Body Irradiation'], 'description': 'Undergo total body irradiation', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2']}, {'name': 'Umbilical Cord Blood Transplantation', 'type': 'PROCEDURE', 'otherNames': ['Cord Blood Transplantation', 'UCB transplantation'], 'description': 'Undergo umbilical cord blood transplantation', 'armGroupLabels': ['Myeloablative regimen 1', 'Non-myeloablative regimen 2', 'Reduced intensity regimen 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Amanda Olson, MD', 'role': 'CONTACT', 'email': 'alolson@mdanderson.org'}], 'overallOfficials': [{'name': 'Amanda Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}