Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT04534634
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-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': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': '2 years', 'description': 'ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \\<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \\>1.0x 10\\^9/L; platelet count \\>100x10\\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\\<1.0x10\\^9/L) or thrombocytopenia (\\<100x10\\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \\<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'time from enrollment to the date of death from any cause'}, {'measure': 'Leukemia-free survival (LFS)', 'timeFrame': '2 years', 'description': 'time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause'}, {'measure': 'Cumulative incidence of relapse(CIR)', 'timeFrame': '2 years', 'description': 'time from the date of achievement of a remission until the date of relapse'}, {'measure': 'the duration of CAR-T cells in patients', 'timeFrame': '2 years', 'description': "the time of CAR-T cells' persistence in blood and the copies of CAR-T cells"}, {'measure': 'Number of adverse events', 'timeFrame': '2 years', 'description': 'adverse events are evaluated with CTCAE V5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IFN-α, CAR-T'], 'conditions': ['B-cell Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).', 'detailedDescription': 'This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.\n2. Age 12-65.\n3. Eastern Cooperative Oncology Group (ECOG) score 0-2.\n4. Target on leukemia is \\>20% positive detected with flowcytometry.\n5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.\n\n5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \\> 3x upper limit of normal or bilirubin \\> 2.0 mg/dL.\n\n6.No other immunotherapy was received within 3 months.\n\nExclusion Criteria:\n\n1. Patients are pregnant or lactating.\n2. Patients with congenital immunodeficiency.\n3. Patients with central nervous system leukemia.\n4. Patients with uncontrolled active infection.\n5. Patients with active hepatitis B or hepatitis C infection.\n6. Patients with HIV infection.\n7. Patients with atrial or venous thrombosis or embolism.\n8. Patients with myo-infarction or severe arrythmia in the recent 6 months.\n9. Other comorbidities that investigators considered not suitable for this study.'}, 'identificationModule': {'nctId': 'NCT04534634', 'briefTitle': 'Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)', 'orgStudyIdInfo': {'id': 'IFN-α+CAR-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'IFN-α combined with CAR T-cells therapy', 'interventionNames': ['Combination Product: IFN-α combined with CAR-T cell therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'CAR T-cells therapy'}], 'interventions': [{'name': 'IFN-α combined with CAR-T cell therapy', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['CAR-T cell therapy'], 'description': 'Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle.\n\nChildren: 14 daily intramuscular injections 200mg/m\\^2 of Interferon-α for a 28-day cycle.\n\nCAR T cell: (1-2)×10\\^7/kg, intravenously infusion.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaowen tang, doctor', 'role': 'CONTACT', 'email': 'xwtang1020@163.com', 'phone': '13913538266'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'xiaowen tang, Ph.D', 'role': 'CONTACT', 'email': 'xwtang1020@163.com', 'phone': '1391353826'}, {'name': 'depei wu, Ph.D', 'role': 'CONTACT', 'email': 'drwudepei@163.com', 'phone': '86-0512677801856'}], 'overallOfficials': [{'name': 'xiaowen tang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Xiaowen Tang', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}