Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 11:35 AM
Study NCT ID:
NCT05537766
Status:
TERMINATED
Last Update Posted:
2025-03-03
First Post:
2022-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D007938', 'term': 'Leukemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705347', 'term': 'brexucabtagene autoleucel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Sponsor decision to terminate study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM)', 'timeFrame': 'Up to 5 years', 'description': 'Combined rate is defined as the proportion of participants who achieve either CR or VGPR.'}, {'measure': 'Substudy B: Objective Response Rate (ORR) Determined by Central Assessment per the Lugano Classification', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR or partial response (PR).'}, {'measure': 'Substudy C: ORR Determined by Central Assessment per the Lugano Classification', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR or PR.'}, {'measure': 'Substudy D: ORR Determined by Central Assessment per the Response Criteria Described by Grever and Colleagues', 'timeFrame': 'Up to 5 years', 'description': 'ORR is defined as the proportion of participants who achieve either CR or PR.'}], 'secondaryOutcomes': [{'measure': 'All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'CR rate is defined as proportion of participants who achieve CR.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Duration of Response (DOR)', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'DOR is defined as time from first objective response to disease progression per indication specific response criteria or death from any cause.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Overall Survival (OS)', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'OS is defined as the time from enrollment or brexucabtagene autoleucel infusion to death from any cause.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'PFS is defined as the time from enrollment or brexucabtagene autoleucel infusion to disease progression per indication specific response criteria or death from any cause.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT)', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'TTNT defined as the time from enrollment or brexucabtagene autoleucel infusion to the initiation of subsequent anticancer treatment.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Time to First Response', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'Time to first response is defined as the time from enrollment or brexucabtagene autoleucel infusion to first objective response.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Time to Best Response', 'timeFrame': 'Up to 2 years for substudies B and C; Up to 5 years for substudies A and D', 'description': 'Time to best response is defined as the time from enrollment or brexucabtagene autoleucel infusion to best objective response.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'First infusion date up to 2 years plus 30 days for substudies B and C; First infusion date up to 5 years plus 30 days for substudies A and D'}, {'measure': 'All Substudies (Substudies A, B, C and D): Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values', 'timeFrame': 'First infusion date up to 2 years plus 30 days for substudies B and C; First infusion date up to 5 years plus 30 days for substudies A and D'}, {'measure': 'All Substudies (Substudies A, B, C and D): Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)', 'timeFrame': 'First infusion date of brexucabtagene autoleucel up to 28 days', 'description': 'Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Percentage of Participants With Positive Anti-brexucabtagene autoleucel Antibodies', 'timeFrame': 'First infusion date Up to 2 years for substudies B and C; First infusion date Up to 5 years for substudies A and D'}, {'measure': 'All Substudies (Substudies A, B, C and D): Percentage of Participants With Replication-competent Retrovirus (RCR) in Peripheral Blood Mononuclear Cells (PBMCs)', 'timeFrame': 'Baseline, Month 12'}, {'measure': 'All Substudies (Substudies A, B, C and D): Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score', 'timeFrame': 'Baseline, up to 24 months', 'description': 'The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, six (6) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.'}, {'measure': 'All Substudies (Substudies A, B, C and D): Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score', 'timeFrame': 'Baseline, Up to 24 months', 'description': 'The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.'}, {'measure': 'Substudy A: ORR Determined by Central Assessment', 'timeFrame': 'Up to 5 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of CR, VGPR, or PR.'}, {'measure': 'Substudy A: Combined CR and VGPR Rate Determined by Investigator Assessment', 'timeFrame': 'Up to 5 years', 'description': 'Combined rate is defined as the proportion of participants who achieve either CR or VGPR.'}, {'measure': 'Substudy A: PR Rate Determined by Central Assessment', 'timeFrame': 'Up to 5 years', 'description': 'PR rate is defined as proportion of participants who achieve PR.'}, {'measure': 'Substudy A: VGPR Rate Determined by Central Assessment', 'timeFrame': 'Up to 5 years', 'description': 'VGPR rate is defined as proportion of participants who achieve VGPR.'}, {'measure': 'Substudy B: ORR Determined by Investigator Assessment per the Lugano Classification', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR or PR.'}, {'measure': 'Substudy B: ORR Determined by Central Assessment per the Lugano Classification', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR or PR, in subgroups by clonal relationship to the underlying CLL. Clonality will be assessed by central assessment.'}, {'measure': 'Substudy B: ORR Determined by Investigator per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 Criteria', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR, complete response with incomplete marrow recovery (CRi) or PR.'}, {'measure': 'Substudy C: ORR Determined by Investigator Assessment per the Lugano Classification', 'timeFrame': 'Up to 2 years', 'description': 'ORR is defined as the proportion of participants who achieve a best response of either CR or PR.'}, {'measure': 'Substudy D: ORR Determined by Investigator Assessment', 'timeFrame': 'Up to 5 years', 'description': 'ORR is defined as the proportion of participants who achieve either CR or PR.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Waldenstrom Macroglobulinemia', 'Relapsed/Refractory Richter Transformation', 'Relapsed/Refractory Burkitt Lymphoma', 'Relapsed/Refractory Hairy Cell Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=KT-US-568-0138', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A - no longer recruiting), relapsed/refractory Richter transformation (r/r RT) (Substudy B), relapsed/refractory Burkitt lymphoma (r/r BL) (Substudy C and relapsed/refractory hairy cell leukemia (r/r HCL) (Substudy D - no longer recruiting).', 'detailedDescription': 'Master protocol: The primary objective of this study is to evaluate the efficacy of brexucabtagene autoleucel in two rare B-cell malignancies. This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL.\n\nAfter completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.\n\nSubstudies A and D have been early terminated by the sponsor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nAll Substudies:\n\n* Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Adequate hematologic and end-organ function.\n* Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.\n\nSubstudy B:\n\n* Confirmed diagnosis of chronic lymphocytic leukemia (CLL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria with histologically confirmed Richter transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype.\n* Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:\n\n * Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy.\n * Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.\n* At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\nSubstudy C:\n\n* Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:\n\n * Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\n * Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.\n* At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\nKey Exclusion Criteria:\n\nAll Substudies:\n\n* Prior CAR therapy or treatment with any anti-CD19 therapy.\n* HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count \\> 200 cells/uL.\n* Presence of detectable cerebrospinal fluid malignant cells or brain metastases.\n* History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus).\n\nSubstudy B:\n\n* Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma (HL) and prolymphocytic leukemia).\n* Prior allogeneic or autologous stem cell transplant \\< 3 months prior to screening and/or \\< 4 months prior to planned infusion of brexucabtagene autoleucel.\n* Presence of active graft-versus-host disease following prior stem cell transplant.\n\nSubstudy C:\n\n* Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified.\n* Prior allogeneic stem cell transplant \\< 3 months prior to screening and/or \\< 4 months prior to planned infusion of brexucabtagene autoleucel.\n* Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.\n* Presence of CNS involvement. Individuals with a prior history of CNS involvement are eligible if they show a negative CSF and no involvement by imaging.\n\nSubstudies A and D have been early terminated by the sponsor.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05537766', 'acronym': 'ZUMA-25', 'briefTitle': 'Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)', 'orgStudyIdInfo': {'id': 'KT-US-568-0138'}, 'secondaryIdInfos': [{'id': '2022-501259-10', 'type': 'OTHER', 'domain': 'European Medicines Agency'}, {'id': '2022-501260-18', 'type': 'OTHER', 'domain': 'European Medicines Agency'}, {'id': '2022-501261-46', 'type': 'OTHER', 'domain': 'European Medicines Agency'}, {'id': '2022-501262-21', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel', 'description': 'Participants will receive fludarabine 30 mg/m\\^2/day and cyclophosphamide 500 mg/m\\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2 × 10\\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg.\n\nThis arm is no longer recruiting.', 'interventionNames': ['Biological: Brexucabtagene Autoleucel', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel', 'description': 'Participants will receive fludarabine 30 mg/m\\^2/day and cyclophosphamide 500 mg/m\\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at target dose of 2×10\\^6 anti-CD19 CAR T cells/kg.\n\nThis arm is no longer recruiting.', 'interventionNames': ['Biological: Brexucabtagene Autoleucel', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel', 'description': 'Participants will receive fludarabine 30 mg/m\\^2/day and cyclophosphamide 500 mg/m\\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2x10\\^6 anti-CD19 CAR T cells/kg.', 'interventionNames': ['Biological: Brexucabtagene Autoleucel', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel', 'description': 'Participants will receive fludarabine 30 mg/m\\^2/day and cyclophosphamide 500 mg/m\\^2/day lymphodepletion chemotherapy for 3 days followed by a single infusion of brexucabtagene autoleucel at a target dose of 2 × 10\\^6 anti-CD19 CAR T cells/kg.\n\nThis arm is no longer recruiting.', 'interventionNames': ['Biological: Brexucabtagene Autoleucel', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}], 'interventions': [{'name': 'Brexucabtagene Autoleucel', 'type': 'BIOLOGICAL', 'otherNames': ['KTE-X19'], 'description': 'Administered intravenously', 'armGroupLabels': ['Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel', 'Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel', 'Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel', 'Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel', 'Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel', 'Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel', 'Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel', 'Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel', 'Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel', 'Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope (City of Hope National Medical Center)', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Centre', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center - James Cancer HospitalS', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '01090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Internal Medicine I, Div. of Hematology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital de la Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre hospitalier de Toulouse - Hematology department', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitatsklinikum Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitatsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitatsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero - Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '06132', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Azienda Ospedale di Perugia - Ospedale S. Maria della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Istituto Oncologico Della Svizzera Italiana (IOSI)', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}], 'overallOfficials': [{'name': 'Kite Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kite, A Gilead Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kite, A Gilead Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}