Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT04423367
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2020-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'within 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of adverse events and severe adverse events', 'timeFrame': 'within 12 weeks'}, {'measure': 'Relapse free survival', 'timeFrame': 'within 24 and 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acquired Pure Red Cell Aplasia', 'PRCA', 'Failure or Relapse after First-line Treatment'], 'conditions': ['Acquired Pure Red Cell Aplasia']}, 'referencesModule': {'references': [{'pmid': '33957358', 'type': 'BACKGROUND', 'citation': 'Zhang L, Chen N, Xu Z, Liang Q, Pan H, Zhao J, Fang L, Shi J. Good treatment-free survival of monoclonal gammopathy of undetermined significance associated pure red cell aplasia after bortezomib plus dexamethasone. Blood Cells Mol Dis. 2021 Jul;89:102573. doi: 10.1016/j.bcmd.2021.102573. Epub 2021 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG ≤ 2.\n* Age from 18 to 70.\n* Diagnosed with acquired pure red cell aplasia.\n* Meets the criteria of first-line treatment failure or relapse.\n* Organs in good function.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Nursing woman.\n* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc.\n* Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc.\n* Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma.\n* Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation.\n* Secondary PRCA caused by solid tumors except for thymoma.\n* Secondary PRCA caused by drugs or pregnancy.\n* Secondary PRCA caused by the B19 virus.\n* Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities.\n* Previously received treatment in other trials within 4 weeks before enrollment.\n* Previously treated with the proteasome inhibitor.\n* Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment.\n* Have a history of malignant tumors.\n* Have a history of mental illness.\n* Inability to understand or to follow study procedures.'}, 'identificationModule': {'nctId': 'NCT04423367', 'acronym': 'BID-PERAL', 'briefTitle': 'Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial', 'orgStudyIdInfo': {'id': 'IIT2020010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bortezomib/dexamethasone', 'description': 'Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.', 'interventionNames': ['Drug: bortezomib/dexamethasone']}], 'interventions': [{'name': 'bortezomib/dexamethasone', 'type': 'DRUG', 'description': 'Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.', 'armGroupLabels': ['bortezomib/dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhoukou', 'state': 'Henan', 'country': 'China', 'facility': 'Zhoukou Central Hospital', 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}, {'city': 'Tai’an', 'state': 'Shandong', 'country': 'China', 'facility': 'The Second Affilated Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.18528, 'lon': 117.12}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Regenerative Medicine Center', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Jun Shi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Regenerative Medicine Clinic Center', 'investigatorFullName': 'Jun Shi', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}