Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 2:08 PM
Study NCT ID:
NCT00795769
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2008-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
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{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], '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': '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': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lholmber@fredhutch.org', 'phone': '206-667-6447', 'title': 'Dr. Leona A. Holmberg', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '11 months between August 2008-June 2009', 'eventGroups': [{'id': 'EG000', 'title': 'Ondansteron Therapy', 'description': 'Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.\n\nondansetron: Given IV\n\nsurvey administration: Correlative studies\n\nmanagement of therapy complications: Ondansetron IV', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 18, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nausea', 'notes': 'post stem cell infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea and vomiting', 'notes': 'post stem cell infusion. Also had \\> two point increase from baseline on MAT nausea score', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'notes': 'post stem cell infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ondansetron Therapy', 'description': 'Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.\n\nondansetron: Given IV\n\nsurvey administration: Correlative studies\n\nmanagement of therapy complications: Ondansetron IV'}], 'classes': [{'title': 'MAT score >2 on arrival and pre-ondansetron', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Baseline MAT score >2 prior to first ASCT infusion', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'MAT score increases >2 by end of infusion', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Number of patients that vomited', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'groupDescription': '18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \\<0.0001). PMID: 21372706 reference for historical data at FHCRC', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 120 minutes', 'description': 'Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ondansetron Therapy', 'description': 'Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.\n\nondansetron: Given IV\n\nsurvey administration: Correlative studies\n\nmanagement of therapy complications: Ondansetron IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ondansteron Therapy', 'description': 'Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.\n\nondansetron: Given IV\n\nsurvey administration: Correlative studies\n\nmanagement of therapy complications: Ondansetron IV'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2009-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2008-11-20', 'resultsFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-20', 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)', 'timeFrame': 'Baseline up to 120 minutes', 'description': 'Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accelerated Phase Chronic Myelogenous Leukemia', 'Adult Acute Lymphoblastic Leukemia in Remission', 'Adult Acute Myeloid Leukemia in Remission', 'Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Atypical Chronic Myeloid Leukemia, BCR-ABL Negative', 'Blastic Phase Chronic Myelogenous Leukemia', 'Chronic Eosinophilic Leukemia', 'Chronic Myelomonocytic Leukemia', 'Chronic Neutrophilic Leukemia', 'Chronic Phase Chronic Myelogenous Leukemia', 'de Novo Myelodysplastic Syndromes', 'Disseminated Neuroblastoma', 'Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue', 'Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable', 'Nodal Marginal Zone B-cell Lymphoma', 'Noncontiguous Stage II Adult Burkitt Lymphoma', 'Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma', 'Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma', 'Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma', 'Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma', 'Noncontiguous Stage II Adult Lymphoblastic Lymphoma', 'Noncontiguous Stage II Grade 1 Follicular Lymphoma', 'Noncontiguous Stage II Grade 2 Follicular Lymphoma', 'Noncontiguous Stage II Grade 3 Follicular Lymphoma', 'Noncontiguous Stage II Mantle Cell Lymphoma', 'Noncontiguous Stage II Marginal Zone Lymphoma', 'Noncontiguous Stage II Small Lymphocytic Lymphoma', 'Poor Prognosis Metastatic Gestational Trophoblastic Tumor', 'Previously Treated Myelodysplastic Syndromes', 'Primary Myelofibrosis', 'Recurrent Adult Acute Lymphoblastic Leukemia', 'Recurrent Adult Acute Myeloid Leukemia', 'Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Diffuse Small Cleaved Cell Lymphoma', 'Recurrent Adult Hodgkin Lymphoma', 'Recurrent Adult Immunoblastic Large Cell Lymphoma', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Childhood Large Cell Lymphoma', 'Recurrent Childhood Lymphoblastic Lymphoma', 'Recurrent Childhood Small Noncleaved Cell Lymphoma', 'Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma', 'Recurrent Grade 1 Follicular Lymphoma', 'Recurrent Grade 2 Follicular Lymphoma', 'Recurrent Grade 3 Follicular Lymphoma', 'Recurrent Malignant Testicular Germ Cell Tumor', 'Recurrent Mantle Cell Lymphoma', 'Recurrent Marginal Zone Lymphoma', 'Recurrent Mycosis Fungoides/Sezary Syndrome', 'Recurrent Neuroblastoma', 'Recurrent Ovarian Epithelial Cancer', 'Recurrent Ovarian Germ Cell Tumor', 'Recurrent Small Lymphocytic Lymphoma', 'Recurrent/Refractory Childhood Hodgkin Lymphoma', 'Refractory Chronic Lymphocytic Leukemia', 'Refractory Hairy Cell Leukemia', 'Relapsing Chronic Myelogenous Leukemia', 'Secondary Acute Myeloid Leukemia', 'Secondary Myelodysplastic Syndromes', 'Splenic Marginal Zone Lymphoma', 'Stage I Multiple Myeloma', 'Stage II Multiple Myeloma', 'Stage II Ovarian Epithelial Cancer', 'Stage III Adult Burkitt Lymphoma', 'Stage III Adult Diffuse Large Cell Lymphoma', 'Stage III Adult Diffuse Mixed Cell Lymphoma', 'Stage III Adult Diffuse Small Cleaved Cell Lymphoma', 'Stage III Adult Hodgkin Lymphoma', 'Stage III Adult Immunoblastic Large Cell Lymphoma', 'Stage III Adult Lymphoblastic Lymphoma', 'Stage III Chronic Lymphocytic Leukemia', 'Stage III Grade 1 Follicular Lymphoma', 'Stage III Grade 2 Follicular Lymphoma', 'Stage III Grade 3 Follicular Lymphoma', 'Stage III Malignant Testicular Germ Cell Tumor', 'Stage III Mantle Cell Lymphoma', 'Stage III Marginal Zone Lymphoma', 'Stage III Multiple Myeloma', 'Stage III Ovarian Epithelial Cancer', 'Stage III Small Lymphocytic Lymphoma', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer', 'Stage IV Adult Burkitt Lymphoma', 'Stage IV Adult Diffuse Large Cell Lymphoma', 'Stage IV Adult Diffuse Mixed Cell Lymphoma', 'Stage IV Adult Diffuse Small Cleaved Cell Lymphoma', 'Stage IV Adult Hodgkin Lymphoma', 'Stage IV Adult Immunoblastic Large Cell Lymphoma', 'Stage IV Adult Lymphoblastic Lymphoma', 'Stage IV Breast Cancer', 'Stage IV Chronic Lymphocytic Leukemia', 'Stage IV Grade 1 Follicular Lymphoma', 'Stage IV Grade 2 Follicular Lymphoma', 'Stage IV Grade 3 Follicular Lymphoma', 'Stage IV Mantle Cell Lymphoma', 'Stage IV Marginal Zone Lymphoma', 'Stage IV Ovarian Epithelial Cancer', 'Stage IV Small Lymphocytic Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.\n\nPURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.', 'detailedDescription': 'OBJECTIVES:\n\nI. To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.\n\nII. To determine the number of patients who experience nausea and vomiting.\n\nOUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* Autologous PBSC transplant patient\n* English-speaking\n* Planned cryopreserved PBSC infusion at the SCCA outpatient clinic\n\nExclusion\n\n* History of prior autologous transplant\n* Non-English-speaking\n* Planned cryopreserved PBSC infusion at the UWMC inpatient unit\n* Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion\n* Allergy or adverse reaction to ondansetron'}, 'identificationModule': {'nctId': 'NCT00795769', 'briefTitle': 'Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells', 'orgStudyIdInfo': {'id': '2247.00'}, 'secondaryIdInfos': [{'id': 'NCI-2010-00325', 'type': 'REGISTRY', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ondansetron therapy', 'description': 'Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.', 'interventionNames': ['Drug: ondansetron', 'Other: survey administration', 'Procedure: management of therapy complications']}], 'interventions': [{'name': 'ondansetron', 'type': 'DRUG', 'otherNames': ['GR 38032F', 'GR-C507/75', 'Zofran'], 'description': 'Given IV', 'armGroupLabels': ['Ondansetron therapy']}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ondansetron therapy']}, {'name': 'management of therapy complications', 'type': 'PROCEDURE', 'otherNames': ['complications of therapy, management of'], 'description': 'Ondansetron IV', 'armGroupLabels': ['Ondansetron therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Leona Holmberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leona Holmberg', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}