Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT06250959
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510808', 'term': 'blinatumomab'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite complete remission rate', 'timeFrame': 'Induction therapy phase: The time of bone marrow evaluation is day 28±7.', 'description': 'CR/CRi'}], 'secondaryOutcomes': [{'measure': 'The negative rate of minimal residual lesion (MRD)', 'timeFrame': 'Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.', 'description': 'The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10\\^-4)'}, {'measure': 'Treatment-related AE', 'timeFrame': 'Induction therapy phase', 'description': 'Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.'}, {'measure': 'Quality of survival of patients in the induction therapy phase', 'timeFrame': 'Induction therapy phase', 'description': 'QLQ-C30 Survival Quality Scale'}, {'measure': 'Progression-free survival（PFS）', 'timeFrame': '1 year after study completion', 'description': 'The time from random assignment in a clinical trial to disease progression or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '1 year after study completion', 'description': 'From the time of enrollment in the study to the time of death from any cause.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALL, Adult', 'Philadelphia-Negative ALL']}, 'descriptionModule': {'briefSummary': 'In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.', 'detailedDescription': 'Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.\n\nIn this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.\n\nThe regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 15-65\n* Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria\n* Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days\n* ECOG score 0-3\n* Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)\n* Renal function: endogenous creatinine clearance ≧30ml/min\n* Patients must be able to understand and willing to participate in the study and must sign the informed consent form.\n\nExclusion Criteria:\n\n* Ph+ (BCR-ABL1 positive) ALL\n* T cells ALL\n* Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease\n* Acute mixed-cell leukemia\n* Central nervous system leukemia\n* HIV infection\n* HBV-DNA or HCV-RNA positive\n* Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator\n* Pregnant or breastfeeding patients\n* The study patient was refused enrollment'}, 'identificationModule': {'nctId': 'NCT06250959', 'acronym': 'BEAT-ALL-2024', 'briefTitle': 'RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study', 'orgStudyIdInfo': {'id': 'BEAT-ALL-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced-dose Chemotherapy Followed by Blinatumomab', 'description': 'Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2\\[max 2mg\\], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued.', 'interventionNames': ['Drug: Blinatumomab Injection [Blincyto]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyperCVAD', 'description': 'CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14', 'interventionNames': ['Drug: Doxorubicin']}], 'interventions': [{'name': 'Blinatumomab Injection [Blincyto]', 'type': 'DRUG', 'description': 'Reduced-intensity chemotherapy followed by Blinatumomab', 'armGroupLabels': ['Reduced-dose Chemotherapy Followed by Blinatumomab']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'HyperCVAD regimen', 'armGroupLabels': ['hyperCVAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Lu', 'role': 'CONTACT', 'email': 'lujing@suda.edu.cn', 'phone': '1377183627'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Jing Lu', 'role': 'CONTACT', 'email': 'lujing@suda.edu.cn', 'phone': '1377183627'}], 'overallOfficials': [{'name': 'Jing Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soochow U'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year after the publication of the summary paper', 'ipdSharing': 'YES', 'description': 'Study Protocol, Basic Statistical Analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chen Suning', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Chen Suning', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}