Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT03630159
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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': 'C000626284', 'term': 'tisagenlecleucel'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of participants recieving pembrolizumab per protocol schedule', 'timeFrame': '21 days after first pembrolizumab infusion'}, {'measure': 'Dose Timing part: Incidence of dose limiting toxicities (DLTs)', 'timeFrame': '21 days after first pembrolizumab infusion'}, {'measure': 'Expansion part: Overall response rate (ORR)', 'timeFrame': '3 month post tisagenlecleucel infusion'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': '24 months'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '24 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '24 months'}, {'measure': 'In vivo cellular kinetics of tisagenlecleucel in blood, bone marrow, lymph nodes and other tissues by qPCR and flow cytometry', 'timeFrame': '24 months'}, {'measure': 'Impact of pembrolizumab dosing strategy on the cellular kinetics of tisagenlecleucel by qPCR and flow cytometry', 'timeFrame': '24 months'}, {'measure': 'Immunogenicity measured by antibody titres specific to tisagenlecleucel molecule and by the presence of T lymphocytes activated by the tisagenlecleucel protein', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma tisagenlecleucel', 'Diffuse Large B-cell Lymphoma', 'CTL019', 'PORTIA', 'DLBCL', 'tisagenlecleucel', 'pembrolizumab', 'r/r Diffuse large B-cell Lymphoma', 'relapsed/refractory Diffuse large B-cell Lymphoma'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '36044388', 'type': 'DERIVED', 'citation': 'Jaeger U, Worel N, McGuirk JP, Riedell PA, Fleury I, Du Y, Han X, Pearson D, Redondo S, Waller EK. Safety and efficacy of tisagenlecleucel plus pembrolizumab in patients with r/r DLBCL: phase 1b PORTIA study results. Blood Adv. 2023 Jun 13;7(11):2283-2286. doi: 10.1182/bloodadvances.2022007779.'}, {'pmid': '34515338', 'type': 'DERIVED', 'citation': 'Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17956', 'label': 'Novartis results database'}, {'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1106', 'label': 'A Plain Language Trial Summary is available on novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed DLBCL per local histopathology assessment.\n* Relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being not candidates for or not consenting to ASCT.\n* Measurable disease at time of enrollment\n* ECOG performance status that is either 0 or 1 at screening.\n\nExclusion Criteria:\n\n* Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of CNS.\n* Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy.\n* Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was \\>4 weeks before enrollment.\n* Prior allogeneic HSCT.\n* Unstable angina and/or myocardial infarction and/or coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease\n* Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, other immune checkpoint inhibitors.\n* History of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03630159', 'acronym': 'PORTIA', 'briefTitle': 'Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.', 'orgStudyIdInfo': {'id': 'CCTL019J2101'}, 'secondaryIdInfos': [{'id': '2018-000973-57', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tisagenlecleucel+Pembrolizumab', 'interventionNames': ['Biological: Tisagenlecleucel', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'Tisagenlecleucel', 'type': 'BIOLOGICAL', 'otherNames': ['CTL019'], 'description': 'Gene modified autologous T cells', 'armGroupLabels': ['Tisagenlecleucel+Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'anti PD-1', 'armGroupLabels': ['Tisagenlecleucel+Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine SC CTL019', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center Hematology and Oncology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital and Medical Center U of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}