Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-26 @ 1:27 PM
Study NCT ID:
NCT00714259
Status:
TERMINATED
Last Update Posted:
2017-07-24
First Post:
2008-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'liwilliams@uabmc.edu', 'phone': '20-934-0066', 'title': 'William Vaughan, MD', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'RSV pneumonia Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Klebsiella pneumonia Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia', 'notes': 'Pneumonia not otherwise specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progressive Free Survival Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days post transplant', 'description': 'subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-relapse Treatment Related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 100 days post transplant', 'description': 'Death related to treatment without relapse within 100 days after transplant', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post transplant up to 100 days post transplant', 'description': 'Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.', 'unitOfMeasure': 'participant', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Composite Incidence of Acute and Chronic Graft Versus Host Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 100 days post transplant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progressive Free Survival Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days post transplant', 'description': 'Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progressive Free Survival Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days post transplant', 'description': 'Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years post transplant', 'description': 'Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm Trial', 'description': 'Single Arm Intervention trial as noted in interventions section\n\nFludarabine: Fludarabine 30 mg/m2/day x 3 days\n\nTotal Body Irradiation: TBI 200cGy x1 dose on transplant day\n\nInfusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Accrual goals could not be met within a timely manner', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-22', 'studyFirstSubmitDate': '2008-07-10', 'resultsFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-23', 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progressive Free Survival Post Transplant', 'timeFrame': '100 days post transplant', 'description': 'subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.'}, {'measure': 'Progressive Free Survival Post Transplant', 'timeFrame': '180 days post transplant', 'description': 'Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.'}, {'measure': 'Progressive Free Survival Post Transplant', 'timeFrame': '365 days post transplant', 'description': 'Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.'}, {'measure': 'Progression Free Survival Post Transplant', 'timeFrame': '2 years post transplant', 'description': 'Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.'}], 'secondaryOutcomes': [{'measure': 'Non-relapse Treatment Related Mortality', 'timeFrame': 'Within 100 days post transplant', 'description': 'Death related to treatment without relapse within 100 days after transplant'}, {'measure': 'Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant', 'timeFrame': 'Post transplant up to 100 days post transplant', 'description': 'Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.'}, {'measure': 'Composite Incidence of Acute and Chronic Graft Versus Host Disease', 'timeFrame': 'Up to 100 days post transplant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low Grade B Cell Malignancies', 'nonmyeloablative transplant', 'allogeneic'], 'conditions': ['Multiple Myeloma', 'CLL / SLL', "Non Hodgkin's Lymphoma", 'Waldenstroms', 'Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.', 'detailedDescription': 'Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage II or III non-progressive disease Multiple Myeloma.\n* CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.\n* ≤ 70 years old.\n* Eligible and willing HLA matched related donor.\n* Bilirubin \\<2xULN.\n* ALT and AST \\<3xULN.\n* LVEF \\> 40%.\n* Creatinine Clearance \\>40mL/min.\n* Pulmonary function DLCO corrected to ≥ 70%.\n* Minimum performance score of 70%.\n* Platelet count \\>130 x103 micro L.\n* LDH ≤1.5xULN.\n* No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.\n* No uncontrolled infections.\n\nExclusion Criteria:\n\n* Age \\>70 years old.\n* Performance status \\<70%.\n* Uncontrolled infections or is HIV positive\n* Prior malignancies that are felt to have a \\<80% probability of being cured.\n* Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.\n* Prior Allograft\n* History of rapidly growing disease at diagnosis or at any progression or have MDS.\n* No eligible and willing HLA matched donor.'}, 'identificationModule': {'nctId': 'NCT00714259', 'briefTitle': 'Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies', 'orgStudyIdInfo': {'id': 'F080429003'}, 'secondaryIdInfos': [{'id': 'UAB-0775', 'type': 'OTHER', 'domain': 'UAB Cancer Center study number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non Myeloablative Treatment', 'description': 'Non-myeloablative Transplant Conditioning Chemotherapy :\n\nFludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.', 'interventionNames': ['Drug: Fludarabine', 'Radiation: Total Body Irradiation', 'Other: Infusion of Stem Cells']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Fludarabine 30 mg/m2/day x 3 days', 'armGroupLabels': ['Non Myeloablative Treatment']}, {'name': 'Total Body Irradiation', 'type': 'RADIATION', 'description': 'TBI 200cGy x1 dose on transplant day', 'armGroupLabels': ['Non Myeloablative Treatment']}, {'name': 'Infusion of Stem Cells', 'type': 'OTHER', 'description': 'On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10\\*6 CD34+ cells per kilogram of recipient weight.', 'armGroupLabels': ['Non Myeloablative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249-6979', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama in Birmingham BMT/CT Program Outpatient Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'William P. Vaughan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama in Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Racquel Innis-Shelton, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}