Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT02799550
Status:
UNKNOWN
Last Update Posted:
2019-02-25
First Post:
2016-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of study related adverse events', 'timeFrame': '1 year', 'description': 'defined as \\>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria'}], 'secondaryOutcomes': [{'measure': 'Overall response rate of allogeneic CART-19', 'timeFrame': 'up to 24 weeks', 'description': 'An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR'}, {'measure': 'Disease-free survival', 'timeFrame': 'up to 24 weeks'}, {'measure': 'Overall survival', 'timeFrame': 'up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CART', 'ALL', 'Relapsed', 'Refractory', 'CD19+'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '27887660', 'type': 'DERIVED', 'citation': 'Cai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)', 'detailedDescription': 'The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 60 years\n* Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)\n* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n\nExclusion Criteria:\n\n* Previous treatment with investigational gene or cell therapy medicine products\n* CD19 negative B-cell leukemia\n* Any uncontrolled active medical disorder that would preclude participation as outlined"}, 'identificationModule': {'nctId': 'NCT02799550', 'briefTitle': 'Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}, 'officialTitle': 'Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19', 'orgStudyIdInfo': {'id': 'CART-ALL-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'allogeneic CART-19', 'description': 'infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)', 'interventionNames': ['Biological: allogeneic CART-19']}], 'interventions': [{'name': 'allogeneic CART-19', 'type': 'BIOLOGICAL', 'description': 'allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)', 'armGroupLabels': ['allogeneic CART-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing 100071', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huisheng Ai, MD', 'role': 'CONTACT', 'email': 'huishengai@163.com', 'phone': '86-1066947126'}, {'name': 'Huisheng Ai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Academy of Military Medical Sciences ,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Han, MD', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-13651392893'}, {'name': 'Weidong Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Huisheng Ai, MD', 'role': 'CONTACT', 'email': 'huishengai@163.com', 'phone': '861066947135'}], 'overallOfficials': [{'name': 'Huisheng Ai, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}