Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT06125106
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2023-11-05', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progress-Free Survival', 'timeFrame': 'At Year 1', 'description': 'Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'At Year 1', 'description': 'Overall survival (OS) is defined as the time from transplantation to death'}, {'measure': 'Cumulative Incidence of Relapse', 'timeFrame': 'At Year 1', 'description': 'The time from the date of transplantation to disease recurrence:\n\nDisease recurrence, defined as one of the following:\n\nLeukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.'}, {'measure': 'Non-relapse Mortality', 'timeFrame': 'At Year 1', 'description': 'NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy.'}, {'measure': 'Minimal Residual Disease', 'timeFrame': 'At Year 1', 'description': 'Minimal residual disease is a small number of cancer cells left in the body after treatment.'}, {'measure': 'acute graft versus host disease', 'timeFrame': 'At Day 100', 'description': 'assessment of acute GVHD'}, {'measure': 'chornic graft versus host disease', 'timeFrame': 'At Year 1', 'description': 'assessment of chronic GVHD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimal Residual Disease', 'Allogeneic hematopoietic stem cell transplantation', 'Blinatumomab'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab', 'detailedDescription': 'This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria. After induction and intensified chemotherapy, complete hematological remission was achieved, but MRD was positive by flow cytometry;\n2. Age range from 18 to 70 years old, regardless of gender;\n3. The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;\n4. Female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit;\n5. Organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the Cockcroft Fault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;\n6. Life expectancy greater than 8 weeks;\n7. Voluntarily sign an informed consent form to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Failure to achieve complete hematological remission, including residual extramedullary infiltration;\n2. Previously received hematopoietic stem cell transplantation;\n3. Received systemic chemotherapy within 2 weeks;\n4. Previously received treatment with Blinatumomab;\n5. Have a history of central nervous system leukemia or present with central nervous system leukemia;\n6. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;\n7. Currently suffering from clinically significant active cardiovascular diseases, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardial infarction within 6 months prior to screening;\n8. Chronic obstructive pulmonary disease with whole lung dysfunction;\n9. Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);\n10. Concomitant arteriovenous thrombosis or hypercoagulable state;\n11. Known human immunodeficiency virus (HIV) infection, or chronic infection of hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) beyond drug control;\n12. Pregnant or lactating women;\n13. Severe allergies to other monoclonal antibodies in the past;\n14. Those who are unable to understand, comply with the research protocol or sign an informed consent form.'}, 'identificationModule': {'nctId': 'NCT06125106', 'briefTitle': 'Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab', 'orgStudyIdInfo': {'id': 'IIT20230044C-R1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blinatumomab Group', 'description': 'Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.', 'interventionNames': ['Drug: Blinatumomab']}], 'interventions': [{'name': 'Blinatumomab', 'type': 'DRUG', 'otherNames': ['HSCT'], 'description': 'Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.', 'armGroupLabels': ['Blinatumomab Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '+8615957162012'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jimin Shi', 'role': 'CONTACT', 'email': 'jiminshi@126.com', 'phone': '+8613657119907'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The President of The First Affiliated Hospital, College of Medicine, Zhejiang University', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}