Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT05206357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}, {'id': 'D006402', 'term': 'Hematologic 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': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AE)', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Up to Approximately Week 37', 'description': 'Maximum observed concentration.'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)', 'timeFrame': 'Up to Approximately Week 37', 'description': 'AUC from time 0 to time of last measurable concentration within the dosing interval.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants who Achieve Complete Response (CR)', 'timeFrame': 'Up to Approximately 1 Year', 'description': 'CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).'}, {'measure': 'Number of Participants with Event-free survival (EFS)', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.'}, {'measure': 'Number of Participants who Achieve Overall Survival (OS)', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'OS will be defined as the number of days from screening to the date of death from any cause.'}, {'measure': 'Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy', 'timeFrame': 'Up to Approximately 1 Year', 'description': 'Rate of initiation of stem cell transplantation or CAR-T therapy.'}, {'measure': 'Percentage of Participants Achieving Overall Response (OR)', 'timeFrame': 'Up to Approximately 1 Year', 'description': 'OR is assessed as the percentage of participants with an overall response.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to Approximately 1 Year', 'description': 'DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.'}, {'measure': 'Duration of CR (DOCR)', 'timeFrame': 'Up to Approximately 1 Year', 'description': 'DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.'}, {'measure': 'Percentage of Participants Achieving Immunogenicity', 'timeFrame': 'Up to Approximately Week 37', 'description': 'Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-hodgkin Lymphoma', 'ABBV-GMAB-3013', 'Epcoritamab', "Burkitt's or Burkitt-like Lymphoma/Leukemia", 'Diffuse Large B-cell Lymphoma', 'Aggressive Mature (CD20+) B-cell Lymphoma', 'Cancer', 'Relapsed/Refractory Aggressive Mature B-cell Neoplasms', 'EPCORE'], 'conditions': ['Non-hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.\n\nEpcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.\n\nParticipants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.\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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants \\>= 1 and \\< 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.\n* Disease pathologically confirmed (tumor tissue) by local testing.\n* Relapsed or primary refractory disease meeting any of the following criteria:\n\n * Progressive disease at any time during second-line chemoimmunotherapy (CIT).\n * Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.\n * Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.\n * Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.\n * Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.\n * Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.\n* Recovery from toxic effects of prior chemoimmunotherapy.\n* Performance status by Lansky (\\< 16 years old at evaluation) or Karnofsky (\\>= 16 years old at evaluation) score \\>= 50 or Eastern Cooperative Oncology Group (ECOG) score \\<= 2 .\n* Adequate bone marrow, hepatic, and renal function.\n\nExclusion Criteria:\n\n* Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).\n* Other malignancy requiring therapy.\n* Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents."}, 'identificationModule': {'nctId': 'NCT05206357', 'briefTitle': 'Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genmab'}, 'officialTitle': 'A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms', 'orgStudyIdInfo': {'id': 'M20-429'}, 'secondaryIdInfos': [{'id': '2021-004555-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epcoritamab', 'description': 'Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.', 'interventionNames': ['Drug: Epcoritamab']}], 'interventions': [{'name': 'Epcoritamab', 'type': 'DRUG', 'otherNames': ['ABBV-GMAB-3013'], 'description': 'Subcutaneous Injection (SC)', 'armGroupLabels': ['Epcoritamab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital /ID# 240854", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33155-3009', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital /ID# 241174", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College /ID# 239208', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital /ID# 242765", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center /ID# 239823', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104-4319', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia - Main /ID# 239294", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St Jude Children's Research Hospital /ID# 239184", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390-7208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center /ID# 240892', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead /ID# 240091", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital /ID# 240384", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': "Perth Children'S Hospital /ID# 240382", 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven /ID# 242384', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children /ID# 240767', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine /ID# 240766', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '625 00', 'city': 'Brno', 'state': 'Brno-mesto', 'country': 'Czechia', 'facility': 'Fakultní Nemocnice Brno - Jihlavská /ID# 239956', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '150 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Duplicate_Fakultni Nemocnice v Motole /ID# 239957', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '33076', 'city': 'Bordeaux', 'state': 'Nouvelle-Aquitaine', 'country': 'France', 'facility': 'CHU Bordeaux - Hopital Pellegrin /ID# 240832', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'CHU de Nantes, Hotel Dieu -HME /ID# 240831', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Val-de-Marne', 'country': 'France', 'facility': 'Institut Gustave Roussy /ID# 240966', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon /ID# 240834', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Universitaetsklinikum Erlangen /ID# 240861', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '35043', 'city': 'Marburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen und Marburg /ID# 240787', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster /ID# 239970', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '4920235', 'city': 'Petah Tikva', 'state': 'Central District', 'country': 'Israel', 'facility': "Schneider Children's Medical Center /ID# 240171", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '3109601', 'city': 'Haifa', 'state': 'H_efa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 240037', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '5265601', 'city': 'Ramat Gan', 'state': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center /ID# 240670', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '50139', 'city': 'Florence', 'state': 'Firenze', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Meyer /ID# 240049', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20052', 'city': 'Monza', 'state': 'Monza E Brianza', 'country': 'Italy', 'facility': 'Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 245592', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '00165', 'city': 'Rome', 'state': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesù /ID# 240039', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '460-0001', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'NHO Nagoya Medical Center /ID# 246680', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital /ID# 246907', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '534-0021', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital /ID# 246906', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital /ID# 246722'}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Child Health and Development /ID# 246658'}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 239894', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Samsung Medical Center /ID# 239895', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu /ID# 240719', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron /ID# 240715", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Nino Jesus /ID# 240717', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '100', 'city': 'Taipei City', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital /ID# 242890'}, {'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genmab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}