Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT04981795
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2021-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C000613469', 'term': 'tafasitamab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Patterns - Safety', 'timeFrame': '2 Years', 'description': 'Incidence and severity of Treatment-emergent serious AEs (SAEs) and AEs (TEAs)'}, {'measure': 'Treatment Patterns - Effectiveness (a)', 'timeFrame': '2 Years', 'description': 'Objective response rate (ORR)'}, {'measure': 'Treatment Patterns - Effectiveness (b)', 'timeFrame': '2 Years', 'description': 'Complete response (CR) rate'}, {'measure': 'Treatment Patterns - Effectiveness (c)', 'timeFrame': '2 Years', 'description': 'Duration of response (DoR)'}, {'measure': 'Treatment Patterns - Effectiveness (d)', 'timeFrame': '2 Years', 'description': 'OS'}, {'measure': 'Treatment Patterns - Effectiveness (e)', 'timeFrame': '2 Years', 'description': 'Progression-free survival (PFS)'}, {'measure': 'Treatment Patterns - Effectiveness (f)', 'timeFrame': '2 Years', 'description': 'Event-free survival (EFS)'}], 'secondaryOutcomes': [{'measure': 'Physician-reported clinical outcome (a)', 'timeFrame': '2 Years', 'description': 'Number of treatment lines prior to receiving tafasitamab'}, {'measure': 'Physician-reported clinical outcome (b)', 'timeFrame': '2 Years', 'description': 'Distribution of treatment regimens by lines of therapy prior to and subsequent to tafasitamab treatment Duration of tafasitamab treatment (regardless of concomitant treatment with lenalidomide)'}, {'measure': 'Physician-reported clinical outcome (c)', 'timeFrame': '2 Years', 'description': 'Duration of combination treatment (i.e., duration of treatment with both tafasitamab and lenalidomide)'}, {'measure': 'Physician-reported clinical outcome (d)', 'timeFrame': '2 Years', 'description': 'Modifications of dose and treatment schedule of tafasitamab and/or lenalidomide'}, {'measure': 'Physician-reported clinical outcome (e)', 'timeFrame': '2 Years', 'description': 'Incidence of tafasitamab use with combination partners other than lenalidomide'}, {'measure': 'Physician-reported clinical outcome (f)', 'timeFrame': '2 Years', 'description': 'Incidence of tafasitamab use as monotherapy (i.e., without any combination partners)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DLBCL', 'Lymphoma'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '32511983', 'type': 'BACKGROUND', 'citation': 'Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.'}, {'pmid': '34196165', 'type': 'BACKGROUND', 'citation': 'Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958.'}, {'pmid': '37646664', 'type': 'BACKGROUND', 'citation': 'Duell J, Abrisqueta P, Andre M, Gaidano G, Gonzales-Barca E, Jurczak W, Kalakonda N, Liberati AM, Maddocks KJ, Menne T, Nagy Z, Tournilhac O, Kuffer C, Bakuli A, Amin A, Gurbanov K, Salles G. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024 Feb 1;109(2):553-566. doi: 10.3324/haematol.2023.283480.'}], 'seeAlsoLinks': [{'url': 'https://www.incyteclinicaltrials.com/study/?id=MOR208C414&SearchTerm=MOR208C414&Latitude=&Longitude=&LocationName=&conditions=&Status=&phases=&AgeRanges=&gender=&StudyTypes=&AttachmentTypes=&MileRadius=100&PageIndex=0&PageSize=10&SortField=&SortOrder=&hasResults=', 'label': 'realMIND: Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide in Patients With Relapsed or Refractory DLBCL (realMIND)'}]}, 'descriptionModule': {'briefSummary': 'The realMIND study is a multicenter, observational study intended to further characterize the safety and effectiveness data of US patients (with a focus on racial and ethnic minority patients) with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treated with tafasitamab in combination with lenalidomide.', 'detailedDescription': "This observational study is intended to further characterize the safety and effectiveness of tafasitamab, in combination with lenalidomide, in patients with R/R DLBCL in the US, with a focus on racial and ethnic minorities.\n\nThis study also characterizes the overall treatment patterns (e.g., line of treatment, dose modification, combination partners, use as monotherapy) of US patients with R/R DLBCL who have been treated with tafasitamab with a focus on racial and ethnic minorities This multicenter real-world study will help to characterize the use of tafasitamab (e.g., line of treatment, dose modification, combination partners, use as monotherapy) among US patients with R/R DLBCL with a focus on racial and ethnic minorities This is an observational study; as such, no study visits or assessments, laboratory tests or procedures are mandated by the study. Patients will be evaluated and treated according to the physician's usual practice and discretion.\n\nPatient data for this observational study will be collected in one of two ways; either\n\n* by prospective follow-up of patients included at study sites, or\n* by retrospective collection of data from patient records, at study sites or from vendor databases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community Study- 40 sites across the USA', 'healthyVolunteers': False, 'eligibilityCriteria': "Criteria: Inclusion Criteria:\n\n1. Age ≥18 years at the time of diagnosis of R/R DLBCL\n2. Initiated or initiating tafasitamab treatment\n3. R/R DLBCL patients who have received at least one (1) prior line of treatment for DLBCL\n4. Histologically confirmed DLBCL such as:\n\n a) DLBCL not otherwise specified (NOS) b) T-cell histiocyte-rich large B-cell lymphoma (THRLBCL) c) Epstein-Barr virus (EBV)-positive DLBCL of the elderly d) Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification e) Patients with evidence of histological transformation to DLBCL from an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such as follicular lymphoma \\[FL\\], marginal zone lymphoma \\[MZL\\], chronic lymphocytic leukemia \\[CLL\\]) with a subsequent DLBCL relapse f) High-grade B-cell lymphoma: i) DLBCL with MYC and BCL2 or BCL6 translocation (double-hit) and MYC and BCL2 and BCL6 translocations (triple-hit) ii) High-grade B-cell lymphoma, NOS\n5. Signed and dated ICF by the patient or the patient's Legally Acceptable Representative (LAR), for patients with prospective data collection, as applicable. For deceased or otherwise unreachable patients, no informed consent will be obtained for data collection in the study, provided that the competent Independent Ethics Committee (IEC)/Institutional Review Board (IRB) has provided favorable opinion and that any other local regulatory requirements on this matter are met\n\nExclusion Criteria:\n\n• Initiated or initiating tafasitamab treatment in the context of an interventional study."}, 'identificationModule': {'nctId': 'NCT04981795', 'acronym': 'realMIND', 'briefTitle': 'realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'realMIND: A Multicenter, Observational Study to Characterize the Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in US Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma With a Focus on Racial and Ethnic Minority Patients', 'orgStudyIdInfo': {'id': 'MOR208C414'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Group 1: Racial and ethnic minority patients (at least 50 patients)', 'interventionNames': ['Drug: Tafasitamab']}, {'label': '2', 'description': 'Group 2: Non Hispanic White (NHM) patients (at least 50 patients)', 'interventionNames': ['Drug: Tafasitamab']}], 'interventions': [{'name': 'Tafasitamab', 'type': 'DRUG', 'description': 'Observational Study on safety and effectiveness of tafasitamab in combination with lenalidomide inPatients With Relapsed or Refractory DLBCL.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Contorno', 'role': 'CONTACT', 'email': 'daniel.contorno@alabamaoncology.com', 'phone': '205-786-6987'}, {'name': 'Katisha Vance', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alabama Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Pauli', 'role': 'CONTACT', 'email': 'leslies@ccihsv.com', 'phone': '256-705-4246'}, {'name': 'Jorge Diaz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clearview Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yun-Pei (Alice) Ting', 'role': 'CONTACT', 'email': 'yunpeit@hs.uci.edu', 'phone': '714-509-2414'}, {'name': 'Elizabeth Brem', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chaney Phipps Phipps', 'role': 'CONTACT', 'email': 'cphipps@mcfarlandclinic.com', 'phone': '515-965-4165'}, {'name': 'Joseph Merchant', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McFarland Clinic P.C.', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peggy Graham', 'role': 'CONTACT', 'email': 'pgraham@missioncancer.com', 'phone': '515-282-2921'}, {'name': 'Tara Graff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mission Cancer and Blood', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Tulane Cancer Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Stutzman', 'role': 'CONTACT', 'email': 'taylor.stutzman@aoncology.com', 'phone': '301-571-2016'}, {'name': 'Bruce Cheson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'American Oncology Partners of Maryland PA', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Avery Polk', 'role': 'CONTACT', 'email': 'polka@med.umich.edu', 'phone': '734-936-3879'}, {'name': 'Yasmin Karimi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan Comprehensive Cancer Center Michigan Medicine', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Pearce', 'role': 'CONTACT', 'email': 'tpearce1@hfhs.org', 'phone': '313-916-1784'}, {'name': 'Philip Kuriakose', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07960-6136', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maureen Nowakowski', 'role': 'CONTACT', 'email': 'maureen.nowakowski@atlantichealth.org', 'phone': '973-971-5569'}, {'name': 'Charles Farber', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '08903-2681', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Damayanti Bhavsar', 'role': 'CONTACT', 'email': 'bhavsadm@cinj.rutgers.edu', 'phone': '732-235-5972'}, {'name': 'Andrew Evens', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10532', 'city': 'Hawthorne', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miles Jackson', 'role': 'CONTACT', 'email': 'mjackson3@nymc.edu', 'phone': '914-493-8375'}, {'name': 'Liu Delong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.10732, 'lon': -73.79597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alicia Patrick', 'role': 'CONTACT', 'email': 'alicia.patrick@atriumhealth.org', 'phone': '704-355-8298'}, {'name': 'Nilanjan Ghosh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Ordman', 'role': 'CONTACT', 'email': 'jennifer.ordman@va.gov', 'phone': '708-796-1601'}, {'name': 'Thomas Rodgers', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Medical Center - Durham', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denise Brigham', 'role': 'CONTACT', 'email': 'brighamd16@ecu.edu', 'phone': '252-744-4924'}, {'name': 'Darla Liles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leo Jenkins Cancer Center/ECU School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Duffy', 'role': 'CONTACT', 'email': 'duffyt2@ccf.org', 'phone': '330-430-2788'}, {'name': 'Mitchell Haut', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claire Limbert', 'role': 'CONTACT', 'email': 'claire.limbert@osumc.edu', 'phone': '614-566-1261'}, {'name': 'Basem William', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio Health Marion Area Physicians', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Duffy', 'role': 'CONTACT', 'email': 'duffyt2@ccf.org', 'phone': '330-430-2788'}, {'name': 'Nagaprasad Nagajothi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tri County Hematology & Oncology Associates, Inc', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'zip': '73142', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kellie Larsen', 'role': 'CONTACT', 'email': 'kellie.larsen@integrisok.com', 'phone': '405-773-6613'}, {'name': 'Romero Mandanas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Integris Cancer Institute of Oklahoma', 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{'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Keshmiri', 'role': 'CONTACT', 'email': 'skeshmir@fredhutch.org', 'phone': '206-667-1429'}, {'name': 'Mazyar Shadman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UW Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beth Parker', 'role': 'CONTACT', 'email': 'beth.parker@multicare.org', 'phone': '509-574-3493'}, {'name': 'Silva Mannem', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yakima Valley Memorial Hospital/North Star Lodge', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jiaxin Xing', 'role': 'CONTACT', 'email': 'jxing@mcw.edu', 'phone': '414-805-9951'}, {'name': 'Mehdi Hamadani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Froedtert & Medical College Clinics', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Incyte Corporation Call Center (US)', 'role': 'CONTACT', 'email': 'medinfo@incyte.com', 'phone': '1.855.463.3463'}], 'overallOfficials': [{'name': 'John P Galvin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}