Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-25 @ 9:14 AM
Study NCT ID:
NCT00775632
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008727', 'term': 'Methotrexate'}], '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'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-17', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic extensive GVHD at 1-year (yes vs. no)', 'timeFrame': '12 months from the date of transplant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Graft Versus Host Disease', 'Alemtuzumab', 'Campath', 'Bone Marrow Transplants'], 'conditions': ['Graft Versus Host Disease', 'Bone Marrow Transplantation']}, 'descriptionModule': {'briefSummary': 'Graft versus host disease (GVHD) is one of the common complications after stem cell transplant. This is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient.\n\nRecently, an antibody (protein) called alemtuzumab or Campath has been found to be effective in the prevention of Graft vs. Host Disease.\n\nPrevious studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of this study is:\n\n* To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without increasing the risk of relapse (your condition getting worse).\n* To find whether low dose of alemtuzumab in combination with cyclosporine can prevent GVHD more effectively when compared to current standard of care and does not increase the risk of recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a hematological malignancy\n* Peripheral blood as source of stem cells\n* Able to give informed consent\n* Availability of 6/6 matched sibling donor\n* Fit for transplant using a conventional or reduced intensity approach\n\nExclusion Criteria:\n\n* AST/ALT \\>3 x IULN at the time of transplant\n* Serum creatinine \\> 1.5 x IULN at the time of transplant\n* Prior allogeneic transplant\n* Syngeneic donor\n* Active uncontrolled infection\n* HIV positive\n* Pregnancy at the time of BMT'}, 'identificationModule': {'nctId': 'NCT00775632', 'briefTitle': 'Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies', 'orgStudyIdInfo': {'id': 'UHN REB 07-0436C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.', 'interventionNames': ['Drug: mycophenolate or cyclosporine and methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Cyclosporine and Campath', 'description': 'The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.', 'interventionNames': ['Drug: Alemtuzumab']}], 'interventions': [{'name': 'Alemtuzumab', 'type': 'DRUG', 'description': 'A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.', 'armGroupLabels': ['Cyclosporine and Campath']}, {'name': 'mycophenolate or cyclosporine and methotrexate', 'type': 'DRUG', 'description': 'One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vikas Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heath Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}