Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-20 @ 2:26 PM
Study NCT ID:
NCT00450450
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2007-03-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D054429', 'term': 'Leukemia, Myelomonocytic, Juvenile'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'ASCT0631 is closed to further patient entry as of 11/25/2011 due to poor accrual.'}}, 'adverseEventsModule': {'description': "Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.", 'eventGroups': [{'id': 'EG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)', 'otherNumAtRisk': 13, 'otherNumAffected': 8, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)', 'otherNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Autoimmune disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Peripheral nerve infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Rectal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Investigations'}], 'seriousEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Two-year Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '86'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 2 years', 'description': 'EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Estimated Graft Failure Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 years', 'description': 'Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient is inevaluable for EFS on experimental arm and is excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}, {'value': '15.38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient is inevaluable and is excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Estimated 100-day Transplant Related Mortality (TRM) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.69', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Death in a patient after transplant due to protocol treatment is defined as an TRM.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient is inevaluable and is excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months post-transplant', 'description': 'cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Included only patients survived beyond 100 days.'}, {'type': 'SECONDARY', 'title': 'Estimated Median Time to Neutrophil Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '25'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 10 years', 'description': 'Median Time from transplant to neutrophil engraftment', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient was inevaluable and excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Estimated Median Length of Initial Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'timeFrame': 'Up to 10 years', 'description': 'Estimated and compared between randomization arms using the Wilcoxon rank-sum test.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data regarding length of Initial Hospitalization are not collected for this study according to Study Chair.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immune Reconstitution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'timeFrame': 'Up to 1 year', 'description': 'Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are not collected for this study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Infused Nucleated and CD34+ Cell Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'OG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'timeFrame': 'Up to 10 years', 'description': 'Compared using the Wilcoxon rank-sum test.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are not collected for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'FG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Missing Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control BM Arm', 'description': 'Conventional bone marrow transplant (BM)'}, {'id': 'BG001', 'title': 'Experimental G-BM Arm', 'description': 'G-CSF (filgrastim) stimulated bone marrow (G-BM)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '20'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Whole year', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': "Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13."}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2007-03-20', 'resultsFirstSubmitDate': '2016-11-10', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-29', 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune Reconstitution', 'timeFrame': 'Up to 1 year', 'description': 'Summarized graphically. Generalized estimating equation will be used to model the levels as a function of time and randomization assignment and to test the impact of G-CSF stimulation on immune reconstruction.'}, {'measure': 'Infused Nucleated and CD34+ Cell Doses', 'timeFrame': 'Up to 10 years', 'description': 'Compared using the Wilcoxon rank-sum test.'}], 'primaryOutcomes': [{'measure': 'Estimated Two-year Event-free Survival (EFS)', 'timeFrame': 'at 2 years', 'description': 'EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.'}], 'secondaryOutcomes': [{'measure': 'Estimated Graft Failure Rate', 'timeFrame': 'Up to 10 years', 'description': 'Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.'}, {'measure': 'Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)', 'timeFrame': 'Up to 3 months', 'description': 'Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.'}, {'measure': 'Estimated 100-day Transplant Related Mortality (TRM) Percentage', 'timeFrame': '100 days', 'description': 'Death in a patient after transplant due to protocol treatment is defined as an TRM.'}, {'measure': 'Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)', 'timeFrame': '18 months post-transplant', 'description': 'cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.'}, {'measure': 'Estimated Median Time to Neutrophil Engraftment', 'timeFrame': 'Up to 10 years', 'description': 'Median Time from transplant to neutrophil engraftment'}, {'measure': 'Estimated Median Length of Initial Hospitalization', 'timeFrame': 'Up to 10 years', 'description': 'Estimated and compared between randomization arms using the Wilcoxon rank-sum test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Childhood Acute Lymphoblastic Leukemia in Remission', 'Childhood Acute Myeloid Leukemia in Remission', 'Childhood Chronic Myelogenous Leukemia', 'Childhood Myelodysplastic Syndromes', 'Chronic Phase Chronic Myelogenous Leukemia', 'de Novo Myelodysplastic Syndromes', 'Juvenile Myelomonocytic Leukemia', 'Previously Treated Myelodysplastic Syndromes', 'Recurrent Childhood Acute Lymphoblastic Leukemia', 'Secondary Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': "This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Compare improvement in event-free survival of patients with hematologic cancer or other diseases undergoing filgrastim (G-CSF)-stimulated bone marrow transplantation (BMT) vs conventional BMT.\n\nSECONDARY OBJECTIVES:\n\nI. Compare the incidence and time to engraftment in patients treated with these regimens.\n\nII. Compare rates of acute and chronic graft-vs-host disease (GVHD) in patients treated with these regimens.\n\nIII. Correlate incidence of acute and chronic GVHD with absolute T-cell numbers, Th1 vs Th2 profile of T cells, dendritic cell populations, and T-regulatory cell content.\n\nIV. Assess the impact of G-CSF-stimulated BMT as a stem cell source on hospital stay and treatment-related mortality at day 100 in patients treated with this regimen.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk (high vs intermediate vs standard).\n\nCONDITIONING REGIMEN: Co-enrolled on COG-ASCT0431 or COG-AAML0531; Patients receive a conditioning regimen as defined on that treatment study.\n\nACUTE LYMPHOBLASTIC LEUKEMIA (ALL): Patients undergo total-body irradiation (TBI) twice daily on days -8 to -6. Patients receive thiotepa IV on days -5 and -4 and high-dose cyclophosphamide IV over 1 hour on days -3 and -2. Some patients with CNS leukemia or very high-risk ALL in first complete remission receive cranial radiotherapy.\n\nACUTE MYELOID LEUKEMIA, JUVENILE MYELOMONOCYTIC, CHRONIC MYELOGENOUS LEUKEMIA, OR MYELODYSPLASTIC SYNDROMES: (myeloid malignancies) Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -6 and high-dose cyclophosphamide IV over 1 hour on days -5 to -2.\n\nGRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Co-enrolled on COG-ASCT0431 or COG-AAML0531: Patients undergo GVHD prophylaxis as defined on that treatment study.\n\nALL: Patients receive tacrolimus IV or orally beginning on day -2 and continuing until day 42, followed by a taper until day 98. Patients also receive methotrexate IV on days 1, 3, and 6.\n\nMYELOID MALIGNANCIES: Patients receive cyclosporine IV continuously or orally beginning on day -1 and continuing until day 42 or day 50, followed by a taper for 8-16 weeks. Patients also receive methotrexate IV on days 1, 3, 6, and 11.\n\nALLOGENEIC BONE MARROW TRANSPLANTATION (BMT): Patients are randomized to 1 of 2 transplantation arms.\n\nARM I: Patients undergo filgrastim (G-CSF) -stimulated allogeneic BMT on day 0.\n\nARM II: Patients undergo conventional allogeneic BMT on day 0.\n\nAfter completion of study treatment, patients are followed at 1 year and then annually for 5-10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of hematologic cancer or other disease, including any of the following:\n\n * Chronic myelogenous leukemia in first or second chronic phase\n * Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:\n\n * Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received ≥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks)\n * ALL in second complete remission (CR)\\* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse\n * Very high-risk ALL in first CR, defined as any of the following:\n\n * Philadelphia chromosome-positive ALL\n * Hypodiploidy (\\< 44 chromosomes)\n * Mixed lineage leukemia rearrangement\n * Induction failure\n * Acute myeloid leukemia in first or second CR\n\n * Induction therapy must be completed\n * Juvenile myelomonocytic leukemia\n * Myelodysplastic syndromes\n* No clinically evident CNS or extramedullary disease\n* No blasts seen on cerebrospinal fluid cytospin\n* Post-relapse reinduction therapy must be completed\n* Not planning to receive reduced-intensity conditioning regimen\n* Not planning to receive a graft that has undergone T-cell depletion\n* No Down syndrome\n* Matched sibling donor must be available and must be enrolled on ASCT0631D companion study\n* Karnofsky performance status (PS) 60-100% (patients \\> 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years of age)\n* AST or ALT \\< 5 times upper limit of normal for age\n* Bilirubin \\< 2.5 mg/dL (unless due to Gilbert's syndrome)\n* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine base on age and/or gender as follows:\n\n * 0.4 mg/dL (1 month to \\< 6 months of age)\n * 0.5 mg/dL (6 months to \\< 1 year of age)\n * 0.6 mg/dL (1 to 2 years of age)\n * 0.8 mg/dL (2 to \\< 6 years of age)\n * 1.0 mg/dL (6 to \\< 10 years of age)\n * 1.2 mg/dL (10 to \\< 13 years of age)\n * 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \\< 16 years of age)\n * 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)\n* Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram\n* FEV\\_1, FVC, and DLCO ≥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests):\n\n * No evidence of dyspnea at rest\n * No exercise intolerance\n * No requirement for supplemental oxygen therapy\n* Not pregnant or nursing\n* No known HIV\n* No known uncontrolled fungal, bacterial, or viral infections\n\n * Patients acquiring fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT scan\n* No prior allogeneic or autologous stem cell transplantation"}, 'identificationModule': {'nctId': 'NCT00450450', 'briefTitle': 'Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation', 'orgStudyIdInfo': {'id': 'ASCT0631'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01069', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'COG-ASCT0631', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'COG-PBMTC-STC051', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000532926', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients undergo filgrastim (G-CSF)-stimulated allogeneic bone marrow transplantation on day 0.', 'interventionNames': ['Procedure: allogeneic bone marrow transplantation', 'Other: laboratory biomarker analysis', 'Biological: filgrastim']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients undergo conventional allogeneic bone marrow transplantation on day 0.', 'interventionNames': ['Procedure: allogeneic bone marrow transplantation', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'allogeneic bone marrow transplantation', 'type': 'PROCEDURE', 'otherNames': ['bone marrow therapy, allogeneic', 'bone marrow therapy, allogenic', 'transplantation, allogeneic bone marrow', 'transplantation, allogenic bone marrow'], 'description': 'Patients undergo allogeneic BMT', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['Granulocyte Colony-Stimulating Factor', 'r-metHuG-CSF', 'G-CSF', 'Neupogen', 'NSC #614629'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006-3776', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Childrens Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21287-8936', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Childrens Mercy Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Medical Center", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Stephan A. Grupp, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}