Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 7:27 PM
Study NCT ID:
NCT00590460
Status:
TERMINATED
Last Update Posted:
2018-05-24
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005199', 'term': 'Fanconi Anemia'}, {'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D029502', 'term': 'Anemia, Hypoplastic, Congenital'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080984', 'term': 'Congenital Bone Marrow Failure Syndromes'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbrenner@bcm.edu', 'phone': '832-824-4663', 'title': 'Malcolm Brenner, MD', 'organization': 'BAYLOR'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Group1', 'description': 'only one group', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Picorna virus sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Herpes simplex type I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}, {'term': 'Jaw Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}], 'seriousEvents': [{'term': 'CNC hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Donor Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 Days', 'description': 'Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Graft Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group - Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Treated Related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allo Stem Cell Transplant', 'description': 'Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Number of patients with treated related death', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Absolute Neutrophil Count (ANC) of 500/mm3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 Days', 'description': 'Number of days to Absolute neutrophil count (ANC) of 500/mm3', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Platelet Count of 20,000/mm3 Without Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 Days', 'description': 'Number of days to Platelet count of 20,000 / mm3 without transfusions', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants achieved a platelet count of 20,000 / mm3 without transfusions.'}, {'type': 'SECONDARY', 'title': 'Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Number of patients with grade II - IV acute Graft versus Host Disease (GVHD)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Alive at 1 Year Post Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of patients alive at 1 year post allogeneic stem cell transplant', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Limited Chronic GVHD From Day 100 to 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days', 'description': 'Number of patients with limited chronic GVHD from day 100 to 365', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Extensive Chronic GVHD From Day 100 to 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'only one group'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days', 'description': 'Number of patients with extensive chronic GVHD from day 100 to 365.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Grade III - IV Acute GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Allogeneic Stem Cell Transplant', 'description': 'Single Group: Allogeneic Stem Cell Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Number of patients with Grade III-IV acute GVHD', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allo Stem Cell Transplant', 'description': 'Allogeneic Stem Cell Transplant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group1', 'description': 'only one group'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=5 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Between 5 and 9 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Between 10 and 15 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', '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', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-02', 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Donor Engraftment', 'timeFrame': '100 Days', 'description': 'Number of patients with engraftment of at least 65% of donor cells 100 days after transplantation'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Graft Failure', 'timeFrame': '100 days', 'description': 'Graft failure is defined as engraftment of less than 65% of donor cells 100 days after transplantation.'}, {'measure': 'Patients With Treated Related Death', 'timeFrame': '100 days', 'description': 'Number of patients with treated related death'}, {'measure': 'Days to Absolute Neutrophil Count (ANC) of 500/mm3', 'timeFrame': '30 Days', 'description': 'Number of days to Absolute neutrophil count (ANC) of 500/mm3'}, {'measure': 'Days to Platelet Count of 20,000/mm3 Without Transfusions', 'timeFrame': '30 Days', 'description': 'Number of days to Platelet count of 20,000 / mm3 without transfusions'}, {'measure': 'Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)', 'timeFrame': '100 days', 'description': 'Number of patients with grade II - IV acute Graft versus Host Disease (GVHD)'}, {'measure': 'Number of Patients Alive at 1 Year Post Transplant', 'timeFrame': '1 year', 'description': 'Number of patients alive at 1 year post allogeneic stem cell transplant'}, {'measure': 'Patients With Limited Chronic GVHD From Day 100 to 365', 'timeFrame': '365 days', 'description': 'Number of patients with limited chronic GVHD from day 100 to 365'}, {'measure': 'Patients With Extensive Chronic GVHD From Day 100 to 365', 'timeFrame': '365 days', 'description': 'Number of patients with extensive chronic GVHD from day 100 to 365.'}, {'measure': 'Patients With Grade III - IV Acute GVHD', 'timeFrame': '100 days', 'description': 'Number of patients with Grade III-IV acute GVHD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allogeneic Stem Cell Transplant', 'Fanconi Anemia', 'Severe Aplastic Anemia', 'fludarabine', 'campath', 'anti-CD45'], 'conditions': ['Fanconi Anemia', 'Severe Aplastic Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to discover whether children and adults with Fanconi anemia (FA) can be safely and effectively transplanted with Human Leukocyte Antigen (HLA) mismatched (up to one haplotype), HLA-matched sibling, or unrelated donor stem cells, when leukocytolytic monoclonal antibodies are the sole conditioning agents (patients receiving an HLA mismatched transplant will receive Fludarabine as part of the conditioning regimen). Three monoclonal antibodies (MAb) will be used in combination. Two of them, YTH 24 and YTH 54 are rat antibodies directed against two contiguous epitopes on the CD45 (common leucocyte) antigen. They have been safely administered as part of the conditioning regimen for 12 patients receiving allografts (HLA matched and mismatched) at this center. They produce a transient depletion of \\>90% circulating leucocytes. The third MAb is Campath 1H, a humanized rat anti-CD52 MAb. This MAb has been widely used to treat B cell chronic lymphocytic leukemia (B-CLL) and more recently has been safely given at this and other centers as part of a sub-ablative conditioning regimen to patients with malignant disease. Because these MAb produce both profound immunosuppression and significant, though transient, myelodestruction we believe they may be useful as the sole conditioning regimen in patients with Fanconi anemia, in whom the use of conventional chemotherapeutic agents for conditioning produces a high rate of short and long term toxicity. We anticipate MAb mediated subablative conditioning will permit engraftment in a high percentage of these patients with little or no immediate or long term toxicity. Campath IH persists in vivo for several days after administration and so will be present over the transplant period to deplete donor T cells as partial graft versus host disease (GvHD) prophylaxis. Additional GvHD prophylaxis will be provided by administration of the medication FK506.', 'detailedDescription': 'If clinically feasible (no aplasia, no active malignancy), the recipients marrow will be harvested and cryopreserved as a back up for use if non-engraftment/rejection is followed by failure to undergo autologous reconstitution.\n\nFor HLA Mismatched donors, harvested peripheral blood stem cells will be enriched for CD34 cells using the Clinimacs CD34 Reagent system.\n\nFludarabine will be given as 5 daily intravenous infusions. Campath-1H will be given as 3 daily intravenous infusions and will be followed by Anti-CD45 which will be given as four daily intravenous infusions that will be completed two days prior to stem cell infusion. Diphenydramine will be administered intravenously every 4 hours during the period of the course of each infusion.\n\nDay -8 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -7 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -6 Campath 1H as per CAGT SOP Fludarabine 30 mg/m2 -5 YTH 24/54 400ug/kg over 6 hr Fludarabine 30 mg/m2 -4 YTH 24/54 400ug/kg over 6 hr Fludarabine 30 mg/m2 -3 YTH 24/54 400ug/kg over 6 hr -2 YTH 24/54 400ug/kg over 6 hr -1 -0 Stem Cell Infusion\n\nGVHD prophylaxis will be achieved through positive selection for CD34 resulting in \\> 3 log T cell depletion. Previous reports have indicated that there is a low frequency of severe (Grade II/IV) GvHD after haploidentical transplants if recipients receive stem cell populations containing \\<5 x 10e4 CD3 positive T cells. We hope to achieve such levels with our CD34 enrichment protocol. However, pharmacologic prophylaxis will be added if the CD34 selected product contains more than 5 x 10e4 CD3+ve T cells/kg recipient weight. In addition, Campath 1H persists in the recipient circulation through the immediate transplant period and will contribute anti-GVHD activity, in vivo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDiagnosis of Fanconi Anemia or other suspected DNA breakage/chromosomal instability syndromes, such as dyskeratosis congenita or Nijmegen breakage syndrome of all ages are eligible.\n\nDiagnosis of Fanconi anemia confirmed by studies of peripheral blood or bone marrow sensitivity to mitomycin C or DEB or clinical evidence of other DNA breakage/chromosomal instability syndrome as determined by genetic testing or clinical diagnosis by a geneticist\n\nSevere aplasia anemia as evidenced by a hypocellular bone marrow and at least 1 of the 3 criteria below: ANC \\< 500/mm3 Hemoglobin \\< 10 gm/dl with reticulocyte count \\< 1% Platelet count \\< 50,000/mm3\n\nAvailability of an HLA matched or mismatched (up to one haplotype) family member who has been documented not to have Fanconi anemia or of an unrelated HLA matched stem cell donor. Fully matched is defined at 6/6 match by high resolution DR based DNA typing.\n\nLife expectancy greater than 6 weeks limited by diseases other than FA\n\nCreatinine 2X normal for age or less\n\nKarnofsky score 70% or more\n\nExclusion Criteria:\n\nPatients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction less than 25%).\n\nPatients with known allergy to rat serum products.\n\nPatients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation.\n\nPatients with severe personality disorder or mental illness.\n\nPatients with documented HIV positivity.\n\nPregnant\n\nNOTE: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA Reviewer."}, 'identificationModule': {'nctId': 'NCT00590460', 'acronym': 'Mafia', 'briefTitle': 'Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia', 'nctIdAliases': ['NCT00058565'], 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Cd45 (Yth-24 and Yth 54) and Cd52 (Campath-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Donor Stem Cell Transplantation of Patients With Fanconi Anemia', 'orgStudyIdInfo': {'id': 'H-9938'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm Study: Stem Cell Transplant', 'description': 'CAMPATH-1H Anti-CD45 Fludarabine Stem Cell Infusion', 'interventionNames': ['Biological: CAMPATH-1H', 'Biological: Anti-CD45', 'Drug: Fludarabine', 'Procedure: Stem cell infusion']}], 'interventions': [{'name': 'CAMPATH-1H', 'type': 'BIOLOGICAL', 'otherNames': ['Alemtuzumab'], 'description': 'Given intravenous on days -8, -7, and -6', 'armGroupLabels': ['Single Arm Study: Stem Cell Transplant']}, {'name': 'Anti-CD45', 'type': 'BIOLOGICAL', 'description': 'Given intravenous on days -5, -4, -3 and -2\n\ndose is 400 micrograms/kg', 'armGroupLabels': ['Single Arm Study: Stem Cell Transplant']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Given intravenous on days -8, -7, -6, -5 and -4\n\nDose is 30 mg/m2', 'armGroupLabels': ['Single Arm Study: Stem Cell Transplant']}, {'name': 'Stem cell infusion', 'type': 'PROCEDURE', 'description': 'Stem cells are infused on day 0', 'armGroupLabels': ['Single Arm Study: Stem Cell Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Malcolm Brenner, M.B., Ph.D.,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, {'name': 'Center for Cell and Gene Therapy, Baylor College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director Center for Cell and Gene Therapy', 'investigatorFullName': 'Malcolm Brenner', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}