Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT04202835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2019-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'C512542', 'term': 'thymoglobulin'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'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': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized pilot trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2019-11-29', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registration of 80 patients within twenty four months', 'timeFrame': '24 months', 'description': 'Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)'}], 'secondaryOutcomes': [{'measure': 'CRFS', 'timeFrame': '27 months', 'description': 'Chronic graft versus host disease free- and relapse-free survival (CRFS)'}, {'measure': 'GRFS', 'timeFrame': '27 months', 'description': 'Graft versus host disease-, and relapse-, free survival (GRFS)'}, {'measure': 'Survival', 'timeFrame': '27 months', 'description': 'Survival (dead/alive) at 100 days for each patient'}, {'measure': 'Complete data collection', 'timeFrame': '27 months', 'description': 'The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection'}, {'measure': 'Cost of study', 'timeFrame': '27 months', 'description': 'The sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post transplant cyclophosphamide', 'anti-thymocyte globulin'], 'conditions': ['Acute Leukemia', 'Myelodysplasia', 'Chronic Graft-versus-host-disease']}, 'descriptionModule': {'briefSummary': 'A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.', 'detailedDescription': 'Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant is aged ≥ 16 and deemed medically fit per investigator for protocol\n2. The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome\n3. The participant will receive a blood progenitor cell graft ("HPC, Apheresis")\n4. The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB1.\n5. The participant meets the transplant centre\'s criteria for transplantation, using either myeloablative or reduced intensity conditioning.\n6. The participant has good performance status (Karnofsky ≥60%)\n7. The participant is able to understand and sign the informed consent form\n8. Ability and willingness to comply with study procedures and schedule, in the Investigator\'s opinion.\n9. The participant is receiving their first transplant\n\nExclusion Criteria:\n\n1. The participant is HIV antibody positive\n2. The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.\n3. The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)\n4. The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment\n5. The participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3\n6. The participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3\n7. The participant has urinary outflow obstruction\n8. The participant is in poor condition (determined per institutional guidelines)\n9. The participant has acute leukemia in relapse\n10. The participant has myelodysplastic syndrome with \\> 10% marrow blasts\n11. The participant is having their second transplant\n12. The participant is taking T-cell antibody prophylaxis (anti-CD52)\n13. The participant is receiving a cord blood graft or T-cell depleted grafts\n14. The participant has mixed phenotype acute leukemia\n15. The participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \\< 5 years previously must be reviewed and approved by the sponsors.\n16. The participant is in complete remission with incomplete recovery (CRi)'}, 'identificationModule': {'nctId': 'NCT04202835', 'briefTitle': 'ATG Plus PTCy vs ATG for CGVHD Prophylaxis', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD)', 'orgStudyIdInfo': {'id': 'CTTC1901'}, 'secondaryIdInfos': [{'id': 'OZM-099', 'type': 'OTHER', 'domain': 'Ozmosis Research Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATG/PTCy', 'description': 'Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Anti-Thymocyte globulin (rabbit)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ATG', 'description': 'Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).', 'interventionNames': ['Drug: Anti-Thymocyte globulin (rabbit)']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Post Transplant Cyclophosphamide', 'armGroupLabels': ['ATG/PTCy']}, {'name': 'Anti-Thymocyte globulin (rabbit)', 'type': 'DRUG', 'otherNames': ['Thymoglobulin'], 'description': 'Anti-Thymocyte Globulin (rabbit, Thymoglobulin)', 'armGroupLabels': ['ATG', 'ATG/PTCy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Kinghorn Cancer Centre, St Vincent's Health Network", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '3121', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Australasian Leukaemia and Lymphoma Group', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Hospital and Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Hôpital de l'Enfant-Jésus", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatchewan Cancer Agency', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Irwin R Walker, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Kristjan Paulson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CancerCare Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cell Therapy Transplant Canada', 'class': 'UNKNOWN'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Ozmosis Research Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}