Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-27 @ 6:34 AM
Study NCT ID:
NCT04876092
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece', 'Italy', 'Russia', 'South Korea', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551803', 'term': 'ibrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2021-05-04', 'studyFirstSubmitQcDate': '2021-05-04', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Up to 21 days', 'description': 'Percentage of Participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological toxicity or hematological toxicity.'}, {'measure': 'Percentage of Participants with Adverse Events (AEs) by Severity', 'timeFrame': 'Up to 2 years and 9 months', 'description': 'Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of JNJ-67856633 and Ibrutinib', 'timeFrame': 'Up to 2 years and 9 months', 'description': 'Plasma samples will be analyzed to determine concentrations of JNJ-67856633 and Ibrutinib.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Lymphocytic, Chronic, B-Cell', 'Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).', 'detailedDescription': "Non-Hodgkin lymphoma (NHL) represents the most frequent hematologic malignancy in the world and represents a diverse set of diseases. JNJ-67856633-ZAF (referred as JNJ-67856633) is an orally bioavailable, potent, and selective first-in-class mucosa-associated lymphoid tissue lymphoma translocation protein-1 (MALT1) inhibitor. JNJ-67856633 binds to an allosteric site on MALT1 with a mixed-type mechanism. Ibrutinib is a first-in-class, orally administered, potent, orally administered covalently binding small-molecule inhibitor of Bruton's tyrosine kinase (BTK), as well as interleukin-2-inducible kinase (ITK), a tyrosine protein (Tec) kinase family member present in T cells. The doses will be escalated in the study and one or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633 will be determined. The study is divided into 3 periods: a screening phase, a treatment phase, and a post-treatment follow-up phase. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy etc. Safety assessment like physical examination, vital signs, electrocardiogram (ECG), eastern cooperative oncology group (ECOG) performance status, and adverse events monitoring will be performed during the study. Total duration of the study will be up to 2 years and 9 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* Cardiac parameters within the specified range\n* Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barrier method of contraception; b) use a highly effective contraceptive methods; c) not to donate eggs (ova, oocytes) or freeze them for future use for the purposes of assisted reproduction during the study; d) not to plan to become pregnant; e) not to breast-feed\n* Willing and able to adhere to the lifestyle restrictions specified in this protocol\n* Participants must have tumor tissue availability\n* Adequate organ functions\n\nExclusion Criteria:\n\n* Known (active) Central Nervous System (CNS) involvement\n* Prior treatment with JNJ-67856633 or another MALT1 inhibitor that is associated with disease progression or intolerable toxicities'}, 'identificationModule': {'nctId': 'NCT04876092', 'briefTitle': 'A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'CR109010'}, 'secondaryIdInfos': [{'id': '67856633LYM1002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2021-000191-12', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-512689-32-00', 'type': 'REGISTRY', 'domain': 'EUCT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JNJ-67856633 and Ibrutinib', 'description': 'Participants will receive JNJ-67856633 together with Ibrutinib orally on a 21-day cycle. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET).', 'interventionNames': ['Drug: JNJ-67856633', 'Drug: Ibrutinib']}], 'interventions': [{'name': 'JNJ-67856633', 'type': 'DRUG', 'description': 'Participants will receive JNJ-67856633 orally.', 'armGroupLabels': ['JNJ-67856633 and Ibrutinib']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'otherNames': ['JNJ-54179060'], 'description': 'Participants will receive Ibrutinib orally.', 'armGroupLabels': ['JNJ-67856633 and Ibrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes hotel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux - Hospital Haut-Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '30-727', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Pratia MCM Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '60 185', 'city': 'Skorzewo', 'country': 'Poland', 'facility': 'Centrum Medyczne Pratia Poznan', 'geoPoint': {'lat': 54.16909, 'lon': 17.97006}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Universitetssjukhuset Lund, Onkologiska Kliniken, Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}