Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-04-17 @ 4:16 PM
Study NCT ID:
NCT02186860
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2014-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
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': '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-06', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': '8 weeks', 'description': 'To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia'}], 'secondaryOutcomes': [{'measure': 'Clinical responses to third generation CAR-T cells', 'timeFrame': '2 years', 'description': 'To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '28039295', 'type': 'DERIVED', 'citation': 'Tang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904.'}]}, 'descriptionModule': {'briefSummary': 'Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.', 'detailedDescription': 'CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years\n* Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry\n* Refractory or relapsed B cell-acute lymphoblastic leukemia\n* No available curative treatment options (such as hematopoietic stem cell transplantation)\n* Stage III-IV disease\n* Creatinine \\< 2.5 mg/dl\n* Aspartate transaminase-alanine transaminase ratio \\< 3x normal\n* Bilirubin \\< 2.0 mg/dl\n* Karnofsky performance status \\>= 60\n* Expected survival time \\> 3 months\n* Adequate venous access for apheresis\n* Ability to understand and provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patients requiring T cell immunosuppressive therapy\n* Active central nervous system leukemia\n* Any concurrent active malignancies\n* Patients with a history of a seizure disorder or cardiac disorder\n* Patients with human immunodeficiency virus, hepatitis B or C infection\n* Uncontrolled active infection'}, 'identificationModule': {'nctId': 'NCT02186860', 'briefTitle': 'Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences'}, 'officialTitle': 'Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells', 'orgStudyIdInfo': {'id': '307-CTC-CAR T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T cells', 'description': 'Targeting CD19', 'interventionNames': ['Biological: CAR-T cells']}], 'interventions': [{'name': 'CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Given IV', 'armGroupLabels': ['CAR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sun Yao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'suny320@126.com', 'phone': '+86-010-6694-7402'}], 'facility': 'Department of Hematopoietic Stem Cell Transplantation', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yao Sun, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'suny320@126.com', 'phone': '+86-010-6694-7402'}, {'name': 'Liangding Hu, M.D.', 'role': 'CONTACT', 'email': 'huliangding@sohu.com', 'phone': '+86-010-6694-7107'}], 'overallOfficials': [{'name': 'Liangding Hu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital to Academy of Military Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}