Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT00186394
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-23', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Toxicity'}, {'measure': 'Efficacy'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute and chronic GVHD'}]}, 'conditionsModule': {'conditions': ['Lymphoma, Non-Hodgkin', 'Blood and Marrow Transplant (BMT)', 'Lymphomas: Non-Hodgkin']}, 'descriptionModule': {'briefSummary': 'To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.', 'detailedDescription': 'To determine safety and toxicity of a regimen of high dose chemotherapy with allogeneic peripheral blood progenitor cell transplantation; determine the efficacy of the procedure by following clinical outcomes and quality of life measures; and evaluate graft versus host disease incidence and severity with regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:Morphologically confirmed relapsed non-Hodgkin's lymphoma\n\nAge: \\>18 and \\<61 years of age\n\nSigned informed consent Exclusion Criteria:Hepatic dysfunction defined by serum transaminases \\>2.5X normal values\n\nSerum creatinine of \\> 2 mg/dl or creatinine clearance \\< 60 ml/min\n\nDiseases other than non-Hodgkin's lymphoma\n\nPrior bone marrow transplant procedure\n\nSevere psychological or medical illness"}, 'identificationModule': {'nctId': 'NCT00186394', 'briefTitle': "High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': "High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'BMT4L'}, 'secondaryIdInfos': [{'id': '76679'}, {'id': 'BMT4L'}, {'id': 'NCT00186394'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ablative allogeneic hematopoietic cell transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Wen-Kai Weng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Wen-Kai Weng', 'oldOrganization': 'Stanford University School of Medicine'}}}}