Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 5:25 AM
Study NCT ID:
NCT04809467
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-31', 'mcpReleaseN': 30, 'releaseDate': '2025-10-21'}, {'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-10-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'C000613469', 'term': 'tafasitamab'}, {'id': 'C000656179', 'term': 'parsaclisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b : Number of Treatment Emergent Adverse Events', 'timeFrame': 'Up to 25 months', 'description': 'Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'Phase 1b : Incidence of Dose Limiting Toxicities', 'timeFrame': '28 Days', 'description': 'Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. All DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.'}], 'secondaryOutcomes': [{'measure': 'Phase 2a : Overall Response Rate', 'timeFrame': 'Up to 25 months', 'description': 'Defined as the percentage of participants experiencing a best response of Complete Response/Complete Metabolic Response (CR/CMR) or Partial Response/Partial Metabolic Response (PR/PMR) according to the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL.'}, {'measure': 'Pharmacokinetics Parameter : Cmax of tafasitamab', 'timeFrame': 'Up to 24 months', 'description': 'Maximum Observed Plasma Concentration of tafasitamab'}, {'measure': 'Pharmacokinetics Parameter : Cmin of tafasitamab', 'timeFrame': 'Up to 24 months', 'description': 'Minimum Observed Plasma Concentration of tafasitamab'}, {'measure': 'Pharmacokinetics Parameter : Tmax of tafasitamab', 'timeFrame': 'Up to 24 months', 'description': 'Time to reach maximum plasma concentration of tafasitamab'}, {'measure': 'Pharmacokinetics Parameter : AUC(t) of tafasitamab', 'timeFrame': 'Up to 24 months', 'description': 'Area under the concentration-time curve from time zero to time of tafasitamab'}, {'measure': 'Pharmacokinetics Parameter : Ctrough of tafasitamab', 'timeFrame': 'Up to 24 months', 'description': 'C trough concentration of tafasitamab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed or Refractory', 'Leukemia', 'tafasitamab', 'parsaclisib', 'MOR00208', 'INCMOR00208'], 'conditions': ['Chronic Lymphocytic Leukemia', 'Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL\n* Willingness to undergo biopsy\n* At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)\n* Relapsed, progressive, or refractory NHL or CLL\n* For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)\n* ECOG-PS 0 - 2\n* LVEF ≥ 50%\n* Adequate renal, hepatic, bone marrow function\n\nExclusion Criteria:\n\n* Any other histological type of lymphoma\n* Primary or secondary CNS lymphoma\n* Anticancer and/or investigational therapy within the past 30 days or 5 half-lives\n* Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1\n* Previous treatment with CD19-targeted therapy or PI3K inhibitors\n* Clinically significant cardiac disease\n* Other malignancy within the past 3 years\n* Active graft-versus-host disease\n* Stroke or intracranial hemorrhage within the past 6 months\n* Chronic or current active infectious disease\n* Positive virus serology for HCV, HBV, HIV\n* Currently pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04809467', 'acronym': 'topMIND', 'briefTitle': 'A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'INCMOR 0208-101'}, 'secondaryIdInfos': [{'id': '2020-005591-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tafasitamab + parsaclisib', 'description': 'Participants will be assigned to disease specific cohorts based on the histology of their underlying disease.\n\nCohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL', 'interventionNames': ['Drug: tafasitamab', 'Drug: parsaclisib']}], 'interventions': [{'name': 'tafasitamab', 'type': 'DRUG', 'otherNames': ['INCMOR00208'], 'description': 'tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.', 'armGroupLabels': ['tafasitamab + parsaclisib']}, {'name': 'parsaclisib', 'type': 'DRUG', 'otherNames': ['INCB050465'], 'description': 'parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.', 'armGroupLabels': ['tafasitamab + parsaclisib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama At Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Blood and Marrow Transplantation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Health Network, Inc.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cancer Center For Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Alliance', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson University Hospitals', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz Gmbh Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '05020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '01140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '06000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hospital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '02650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen (Uza)', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '08500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'Az Groeninge Campus Kennedylaan', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '03000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis (Uz) Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '08800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ DELTA', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'University Hospital Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Medical Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Justus-Liebig University', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Wurzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'S Orsolas University Hospital Seragnoli Institute of Hematology', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '47014', 'city': 'Meldola', 'country': 'Italy', 'facility': 'Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione Irccs Istituto Nazionale Dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori Irccs Fondazione Pascale', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '48121', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'Ospedale Santa Maria Delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Irccs Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Unviersitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General Universitario Vall D Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hopital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Ico Institut Catala D Oncologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Centro Integral Oncologico Clara Campal (Ciocc)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quironsalud Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41015', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Oliver Manzke, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'url': 'https://www.incyte.com/our-company/compliance-and-transparency', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.', 'ipdSharing': 'YES', 'description': 'Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThe trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency', 'accessCriteria': 'Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}