Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-30 @ 4:49 PM
Study NCT ID:
NCT06609304
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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': 'C000629083', 'term': 'axicabtagene ciloleucel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-09-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one year PFS', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, B-Cell']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Axicabtagene Ciloleucel (axi-cel) works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of axi-cel treatment. The main questions it aims to answer are:\n\n* Does axi-cel treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?\n* What medical problems do participants have when receiving axi-cel treatment?\n\nIn this investigator-initiated, single-arm clinical trial, participants will:\n\n* Receive atezolizumab treatment at 2.0×10\\^6 cells/Kg as a one-time therapy.\n* Visit the clinic as instructed for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form;\n2. 18-70 years of age (inclusive);\n3. Previously untreated CD19-positive large B-cell lymphoma;\n4. Anticipated survival ≥12 weeks;\n5. Adequate bone marrow reserve prior to apheresis\n6. Appropriate organ function:\n7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score of 0 or 1; 8. Absence of CNS lymphoma;\n\n9\\. Negative blood/urine pregnancy test in women of childbearing age.\n\nExclusion Criteria:\n\n1. History of allergy to any of the components of the cell product;\n2. History of stem cell transplantation;\n3. History of organ transplantation;\n4. Presence of active infections;\n5. Current or history of central nervous system disorders;\n6. Previous treatment with other modified T-cell therapy;\n7. Previous treatment with anti-CD19/CD3 or other anti-CD19 therapies;\n8. Malignancies other than those indicated for this trial;\n9. History of any prior systemic immune checkpoint therapy;\n10. History of short-acting cell growth factors or haematopoietic agonists/stimulants ;\n11. History of a live vaccine within 3 months prior to screening;.'}, 'identificationModule': {'nctId': 'NCT06609304', 'acronym': 'axi-cel', 'briefTitle': 'Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhengzhou University'}, 'officialTitle': 'Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'TA2024-252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'axi-cel treatment', 'interventionNames': ['Biological: Axicabtagene Ciloleucel']}], 'interventions': [{'name': 'Axicabtagene Ciloleucel', 'type': 'BIOLOGICAL', 'description': 'Axicabtagene Ciloleucel at 2.0×10\\^6/Kg', 'armGroupLabels': ['axi-cel treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xudong Zhang, PhD', 'role': 'CONTACT', 'email': 'fcczhangxd@zzu.edu.cn', 'phone': '86-0371-66279567'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University, Department of Oncology', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhang, PhD', 'role': 'CONTACT', 'email': 'fcczhangxd@zzu.edu.cn', 'phone': '86-0371-66279567'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mingzhi Zhang', 'investigatorAffiliation': 'Zhengzhou University'}}}}