Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 8:30 PM
Study NCT ID:
NCT05559450
Status:
RECRUITING
Last Update Posted:
2022-09-29
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-20', 'size': 169149, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-26T22:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'From the 1st day to the 720th days after enrollment.', 'description': 'The time from randomization to death from any cause.'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients with negative minimal residual disease (MRD)', 'timeFrame': 'From the 1st day to the 720th days after enrollment.', 'description': 'Negative MRD is defined as below 10-4 by flow cytometry.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the 1st day to the 720th days after enrollment.', 'description': 'It is defined as the total survival of a patient after the hematopoietic stem cell transplantation, until the tumor recurrence or death from any cause.'}, {'measure': 'Cumulative incidence of relapse (CIR)', 'timeFrame': 'From the 1st day to the 720th days after enrollment.', 'description': 'From hematopoietic stem cell transplantation to recurrence, relapse-free death was considered a competing risk event.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '29358182', 'type': 'BACKGROUND', 'citation': 'Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia', 'detailedDescription': 'High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.\n2. ECOG score is 0-2.\n3. Expecting life span is more than 6 months.\n4. Patients are free from severe organ dysfunction.\n\nExclusion Criteria:\n\n1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \\<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \\>2.5mg/ dL or blood Creatinine clearance rate \\< 30ml/min.\n2. Patients are combined with infection or other complications that can not tolerate chemotherapy.\n3. Patients are suffering from central nervous system/solitary extramedullary leukemia.\n4. Patients are considered as tumer progression.\n5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.\n6. Pregnant and lactating women will not be included.'}, 'identificationModule': {'nctId': 'NCT05559450', 'briefTitle': 'Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': '2022019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blinatumomab arm', 'description': 'On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.', 'interventionNames': ['Drug: Blinatumomab']}, {'type': 'OTHER', 'label': 'Conventional therapy', 'description': 'Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.', 'interventionNames': ['Other: Conventional therapy']}], 'interventions': [{'name': 'Blinatumomab', 'type': 'DRUG', 'description': 'Blinatumomab will be bridged to conventional BUCY conditioning regimen.', 'armGroupLabels': ['Blinatumomab arm']}, {'name': 'Conventional therapy', 'type': 'OTHER', 'description': 'Control group will be given conventional BUCY conditioning regimen.', 'armGroupLabels': ['Conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangxiang@suda.edu.cn', 'phone': '15606133002'}], 'facility': 'The first affiliated hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Huizhu Kang, MD', 'role': 'CONTACT', 'email': 'khz11826@sina.com', 'phone': '18761925608'}, {'name': 'Meng Zhou, MD', 'role': 'CONTACT', 'email': 'zhoumeng@suda.edu.cn', 'phone': '15606133002'}], 'overallOfficials': [{'name': 'Yue Han, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': 'Zhongda Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': "The First People's Hospital of Changzhou", 'class': 'OTHER'}, {'name': "Wuxi People's Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wannan Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'HAN Yue', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}