Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01315132
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2011-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Neal.Flomenberg@jefferson.edu', 'phone': '215-955-4367', 'title': 'Neal Flomenberg, MD', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from baseline through one year after transplant', 'eventGroups': [{'id': 'EG000', 'title': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation\n\nMatched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 32, 'seriousNumAtRisk': 46, 'deathsNumAffected': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 35, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation\n\nMatched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Year after transplant', 'description': 'The primary objective of this prospective, phase II trial was to obtain an OS rate of \\>60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The \\>60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Graft Versus Host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation\n\nMatched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization'}], 'classes': [{'categories': [{'title': 'Acute GVHD', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Chronic GVHD', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No GVHD', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Year after transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation\n\nMatched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'not treated due to disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation\n\nMatched Sibling Allogeneic Transplantation: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'While 47 participants were enrolled, one participant was removed from the study prior to treatment and will not be counted in the outcomes of the trial'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-13', 'size': 642614, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-29T17:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2011-03-11', 'resultsFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-27', 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Overall Survival', 'timeFrame': '1 Year after transplant', 'description': 'The primary objective of this prospective, phase II trial was to obtain an OS rate of \\>60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The \\>60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.'}], 'secondaryOutcomes': [{'measure': 'Graft Versus Host Disease (GVHD)', 'timeFrame': '1 Year after transplant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myeloablative Hematopoietic Stem Cell Transplant', 'Cyclophosphamide tolerization', '2 Step Approach', 'Hematological malignancies', 'leukemia', 'lymphoma', 'multiple myeloma', "Hodgkin's Disease"], 'conditions': ['Hematological Malignancies', 'Leukemia', 'Lymphoma', 'Multiple Myeloma', "Hodgkin's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}, {'url': 'http://www.JeffersonHospital.org', 'label': 'Thomas Jefferson University Hospitals'}]}, 'descriptionModule': {'briefSummary': 'This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.', 'detailedDescription': 'This research protocol has been developed for patients undergoing matched-sibling hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2 step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT. The primary research questions relate to immune reconstitution, incidence of GVHD, and relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how it impacts overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:\n\n 1. Age \\> 50 years\n 2. ECOG Performance status of \\<2\n 3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL\n 4. CML 2nd chronic phase, accelerated phase, or blastic phase\n 5. MDS with IPS of Intermediate 2 or greater\n 6. Any myeloproliferative disorder\n 7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure\n 8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT\n 9. Other conditions not listed will be assessed as high-risk by the PI\n2. Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.\n3. Patients must adequate organ function:\n\n 1. LVEF of \\>45%\n 2. DLCO (adjusted for hemoglobin) \\>45% of predicted\n 3. Adequate liver function as defined by a serum bilirubin \\<1.8, AST or ALT \\< 2.5X upper limit of normal\n 4. Creatinine clearance of \\> 60 ml/min\n4. Patients must be willing to use contraception if they have childbearing potential\n5. Able to give informed consent\n\nExclusion Criteria:\n\n1. ECOG performance status of 3 or 4.\n2. HIV positive\n3. Active involvement of the central nervous system with malignancy\n4. Psychiatric disorder that would preclude patients from signing an informed consent\n5. Pregnancy\n6. Patients with life expectancy of \\< 6 months for reasons other than their underlying hematologic/oncologic disorder.'}, 'identificationModule': {'nctId': 'NCT01315132', 'briefTitle': 'A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies', 'orgStudyIdInfo': {'id': '08D.85'}, 'secondaryIdInfos': [{'id': '2007-61', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': 'JT 1275', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allogeneic Transplantation', 'description': 'Matched Sibling Allogeneic Transplantation', 'interventionNames': ['Device: Matched Sibling Allogeneic Transplantation']}], 'interventions': [{'name': 'Matched Sibling Allogeneic Transplantation', 'type': 'DEVICE', 'otherNames': ['CliniMACS'], 'description': 'Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization', 'armGroupLabels': ['Allogeneic Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Neal Flomenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}