Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT06508658
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-14', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A vs Arm B: Progression-Free Survival (PFS)', 'timeFrame': 'Up to 4 Years', 'description': 'PFS is defined as the duration from the date of randomization to the date of disease progression determined per Lugano 2014 criteria as assessed by an independent review committee (IRC), or death, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR)', 'timeFrame': 'Up to 4 Years', 'description': 'CR is defined as the percentage of participants who achieve CR determined by Lugano 2014 criteria, as assessed by an IRC that is blinded to treatment arm prior to the initiation of new anti-lymphoma therapy.'}, {'measure': 'Arm A vs Arm B: Overall Survival (OS)', 'timeFrame': 'Up to 4 Years', 'description': 'OS is defined as the time from randomization to death from any cause.'}, {'measure': 'Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate', 'timeFrame': 'Up to 4 Years', 'description': 'The MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of new anti-lymphoma therapy.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epcoritamab', 'Lenalidomide', 'Rituximab', 'Gemcitabine', 'Oxaliplatin', 'Diffuse Large B-Cell Lymphoma', 'DLBCL', 'Epkinly', 'ABBV-GMAB-3013'], 'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M22-128', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed.\n\nEpcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world.\n\nParticipants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days).\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group Performance status score of 0 to 2.\n* Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.\n* Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.\n* Participant must meet at least 1 of the following criteria:\n\n * Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.\n * Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.\n * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:\n\n * Unable to receive CAR-T therapy due to fitness and/or comorbidity.\n * Lymphocyte apheresis failure.\n * Unwilling to receive CAR-T therapy.\n * Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.\n * Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.\n* Must have measurable disease.\n* Life expectancy \\> 3 months on standard of care treatment at the time of enrolling in the study\n\nExclusion Criteria:\n\n* Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.\n* History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).\n* Documented refractoriness to lenalidomide.'}, 'identificationModule': {'nctId': 'NCT06508658', 'acronym': 'EPCORE DLBCL-4', 'briefTitle': 'A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genmab'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma', 'orgStudyIdInfo': {'id': 'M22-128'}, 'secondaryIdInfos': [{'id': '2024-510965-41', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Epcoritamab Plus Lenalidomide (E-Len)', 'description': 'Participants will receive E-Len for up to 12 cycles (each cycle is 28 days).', 'interventionNames': ['Drug: Epcoritamab', 'Drug: Lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)', 'description': 'Participants will receive R-GemOx for up to 4 cycles (each cycle is 28 days)', 'interventionNames': ['Drug: Rituximab', 'Drug: Oxaliplatin', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Epcoritamab', 'description': 'Participants will receive epcoritamab for up to 12 cycles (each cycle is 28 days).', 'interventionNames': ['Drug: Epcoritamab']}], 'interventions': [{'name': 'Epcoritamab', 'type': 'DRUG', 'description': 'Subcutaneous Injection', 'armGroupLabels': ['Arm A: Epcoritamab Plus Lenalidomide (E-Len)', 'Arm C: Epcoritamab']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Intravenous (IV) Infusion', 'armGroupLabels': ['Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Arm A: Epcoritamab Plus Lenalidomide (E-Len)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'IV Infusion', 'armGroupLabels': ['Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'IV Infusion', 'armGroupLabels': ['Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope National Medical Center /ID# 273338', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Valkyrie Clinical Trials /ID# 269935', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Desert Regional Medical Center /ID# 272437', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City Of Hope - Atlanta /ID# 273092', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rush University Medical Center /ID# 242103', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60099', 'city': 'Zion', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City Of Hope - Chicago /ID# 274430', 'geoPoint': {'lat': 42.44613, 'lon': -87.83285}}, {'zip': '46311', 'city': 'Dyer', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwest Cancer Center - Dyer Clinic /ID# 269787', 'geoPoint': {'lat': 41.4942, 'lon': -87.52171}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Wichita /ID# 270117', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kentucky Chandler Medical Center /ID# 242087', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Maryland, Baltimore /ID# 242216', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Hospital /ID# 266446', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '39501', 'city': 'Gulfport', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gulfport Memorial Hospital /ID# 268104', 'geoPoint': {'lat': 30.36742, 'lon': -89.09282}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New York Medical College /ID# 265799', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'East Carolina University - Brody School of Medicine /ID# 242227', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thompson Cancer Survival Ctr /ID# 242149', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '84405', 'city': 'Ogden', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Cancer Trials Of Utah /ID# 271715', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Utah Cancer Specialists - Salt Lake City /ID# 268603', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Salt Lake City /ID# 265329', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '1629', 'city': 'Pilar', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral /ID# 242791', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': '1114', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Fundaleu /Id# 242789'}, {'zip': '1426', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Aires F.D.', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '+ 54 11 32218900'}], 'facility': 'Instituto Alexander Fleming /ID# 263804'}, {'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Canberra Hospital /ID# 265312', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital /ID# 263242', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Wollongong Hospital /ID# 244646', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Toowoomba Hospital /ID# 263243', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '03 9594 4044'}], 'facility': 'Monash Health - Monash Medical Centre /ID# 262783', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal Perth Hospital /ID# 243790', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel /ID# 242574', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '7301', 'city': 'Boussu', 'state': 'Hainaut', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Centre Hospitalier Epicura - Hornu /ID# 265148', 'geoPoint': {'lat': 50.43417, 'lon': 3.7944}}, {'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven /ID# 246671', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8800', 'city': 'Roeselare', 'state': 'West-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'AZ-Delta /ID# 264740', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '81520-060', 'city': 'Curitiba', 'state': 'Puerto Rico', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital Erasto Gaertner /ID# 264049', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 264045', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '01401-002', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': "Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 263944", 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 242425', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4002', 'city': 'Plovdiv', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'UMHAT Sveti Georgi /ID# 242905', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'UMHAT Sveti Ivan Rilski /ID# 242389', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1797', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'SHAT Hematologic Diseases /ID# 242708', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9009', 'city': 'Varna', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 262761', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '7500921', 'city': 'Providencia', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'facility': 'Fundacion Arturo Lopez Perez /ID# 242421', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'zip': '8420383', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'facility': 'Bradford Hill /ID# 262795', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7650568', 'city': 'Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'facility': 'Clinica Alemana de Santiago /ID# 244139', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking University Third Hospital /ID# 242941', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fujian Province Cancer 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genmab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}