Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06763302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018365', 'term': 'Neoplasm, Residual'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1220}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'event free survival', 'timeFrame': 'From enrollment to the 3-year after the end of treatment', 'description': 'Death during induction, abandonment before complete remission, death in continuous complete remission, relapse, and secondary Death during induction, abandonment before complete remission (CR), death in continuous complete remission (CCR), relapse, and secondary malignancies were considered as events in the calculation of EFS probability.'}, {'measure': 'Relapse free survival', 'timeFrame': 'From enrollment to the 3-year after the end of treatment', 'description': 'RFS was measured by the time from achievement of CR to last follow-up or first relapse and censored at the first event (death, secondary malignancies) except relapse.'}], 'secondaryOutcomes': [{'measure': 'Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'From enrollment to the 3-year after the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Cell Precursor Acute Lymphoblastic Leukemia', 'Pediatric', 'Minimal Residual Disease', 'Next Generation Sequencing (NGS)']}, 'referencesModule': {'references': [{'pmid': '37978187', 'type': 'BACKGROUND', 'citation': 'Chen H, Gu M, Liang J, Song H, Zhang J, Xu W, Zhao F, Shen D, Shen H, Liao C, Tang Y, Xu X. Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL. Nat Commun. 2023 Nov 17;14(1):7468. doi: 10.1038/s41467-023-43171-9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.\n\nThe main questions it aims to answer are:\n\n1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?\n2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).\n* Age ≥1 year and \\<18 years.\n* Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.\n\nExclusion Criteria:\n\n* Age \\<1 year or ≥18 years.\n* Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.\n* Secondary leukemia or second tumor, CML blast phase ALL.\n* Other tumors or immunodeficiency diseases present.'}, 'identificationModule': {'nctId': 'NCT06763302', 'briefTitle': 'NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL', 'organization': {'class': 'OTHER', 'fullName': "The Children's Hospital of Zhejiang University School of Medicine"}, 'officialTitle': 'NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL', 'orgStudyIdInfo': {'id': '2024-IRB-0307-P-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EOC NGS MRD positive Group', 'description': 'Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is positive (≥0.0001%), one course of blinatumomab (28 days) will be added after the consolidation treatment.', 'interventionNames': ['Drug: Blinatumomab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EOC NGS MRD negative Group A', 'description': 'Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\\< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group A will be added by one course of blinatumomab (28 days) treatment after the consolidation treatment.', 'interventionNames': ['Drug: Blinatumomab']}, {'type': 'NO_INTERVENTION', 'label': 'EOC NGS MRD negative Group B', 'description': 'Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (\\< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group B will continue the original chemotherapy treatment plan.'}], 'interventions': [{'name': 'Blinatumomab', 'type': 'DRUG', 'description': 'The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment.', 'armGroupLabels': ['EOC NGS MRD negative Group A', 'EOC NGS MRD positive Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaojun Xu', 'role': 'CONTACT', 'email': 'xuxiaojun@zju.edu.cn', 'phone': '+86-571-88873450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaojun Xu', 'investigatorAffiliation': "The Children's Hospital of Zhejiang University School of Medicine"}}}}