Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-13 @ 5:57 AM
Study NCT ID:
NCT03146468
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2017-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2017-05-07', 'studyFirstSubmitQcDate': '2017-05-07', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft versus host disease', 'timeFrame': '8 weeks', 'description': 'Cumulative incidence of graft versus host disease'}, {'measure': 'Graft versus host disease', 'timeFrame': '24 weeks', 'description': 'Cumulative incidence of graft versus host disease'}, {'measure': 'Graft versus host disease', 'timeFrame': '48 weeks', 'description': 'Cumulative incidence of graft versus host disease'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '8 weeks', 'description': 'Complete remission and partial remission'}, {'measure': 'Overall response rate', 'timeFrame': '16 weeks', 'description': 'Complete remission and partial remission'}, {'measure': 'Overall response rate', 'timeFrame': '24 weeks', 'description': 'Complete remission and partial remission'}, {'measure': 'Overall response rate', 'timeFrame': '48 weeks', 'description': 'Complete remission and partial remission'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haematological Malignancy']}, 'descriptionModule': {'briefSummary': 'This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).\n\nEligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior allogeneic stem cell transplant for a haematological malignancy\n* Confirmed relapse of haematological malignancy or persistent disease post-alloSCT\n* Immunosuppression cessation for minimum of 2 weeks\n* Life expectancy \\> 2 months\n* ECOG performance status 0-2\n* Greater than or equal to 30% CD3+ donor chimerism\n* Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min\n* AST and ALT ≤ 3 times upper limit of normal\n* Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Current evidence of any grade of GVHD\n* Prior history of grade 2 or higher acute GVHD\n* Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD\n* Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)\n* Positive hepatitis B virus surface antigen\n* Positive hepatitis C virus antibody\n* Known human immunodeficiency virus infection'}, 'identificationModule': {'nctId': 'NCT03146468', 'acronym': 'NIVALLO', 'briefTitle': 'Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'officialTitle': 'Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'RMH 2016.281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nivolumab treatment arm', 'description': 'Nivolumab injection 3mg/kg intravenously every 2 weeks', 'interventionNames': ['Drug: Nivolumab Injection']}], 'interventions': [{'name': 'Nivolumab Injection', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor', 'armGroupLabels': ['Nivolumab treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'David Ritchie, FRACP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared by researchers outside of this clinical trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}