Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
NCT ID: NCT05429268
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
82 participants
INTERVENTIONAL
2022-12-23
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tafasitamab and Lenalidomide
Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
Tafasitamab
Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Lenalidomide
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Interventions
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Tafasitamab
Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Lenalidomide
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Diffuse large B-cell lymphoma not otherwise specified
2. T cell/histiocyte-rich large B-cell lymphoma
3. Epstein-Barr virus positive DLBCL of the elderly
4. Grade 3b follicular lymphoma
5. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
6. Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
* Willingness to undergo tumor biopsy requirements for the study, (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1).
* Willingness to undergo bone marrow biopsy/aspirate collections.
* History of relapsed/progressive/recurrent disease according to the International Working Group response criteria after the most recent systemic therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Adequate hematologic, hepatic, and renal function,
* Left ventricular ejection fraction (LVEF) ≥ 50%,
* Willingness to avoid pregnancy or fathering children,
Exclusion Criteria
1. primary mediastinal (thymic) large B-cell lymphoma,
2. Burkitt lymphoma,
3. Primary refractory diffuse large B-cell lymphoma (DLBCL),
4. History of double- or triple-hit DLBCL.
* Participants who, within 30 days prior to Cycle 1 Day 1, have:
1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
2. Undergone major surgery or suffered from significant traumatic injury
3. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
4. Required parenteral antimicrobial therapy for active, intercurrent infections
* Have undergone ASCT within the period ≤ 3 months prior to signing consent.
* Have undergone previous allogenic stem cell transplantation.
* Inadequate recovery (\> Grade 1) from prior treatment toxicity and/or complications from major surgery before Cycle 1 Day 1.
* Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
* Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 years prior to screening.
* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, New York Heart Association Class II to IV congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day 1.
* Any of the following positive tests:
1. Known seropositive for or history of active viral infection with HIV.
2. Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
3. Known positive test results for chronic HBV infection (defined by HBsAg positivity). Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable
18 Years
99 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Manzke, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Medical University Plovdiv
Plovdiv, , Bulgaria
Acibadem Cityclinica Mhat Tokuda
Sofia, , Bulgaria
Umhat Alexandrovska Sofia
Sofia, , Bulgaria
Umhat Sv. Ivan Rilski Ead
Sofia, , Bulgaria
Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
Sofia, , Bulgaria
Clinical Hospital Dubrava
Zagreb, , Croatia
Clinical Hospital Merkur
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreb, , Croatia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Vseobecna Fakultni Nemocnice
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Semmelweis Egyetem
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Markhot Ferenc Korhaz
Eger, , Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Szeged, , Hungary
Bon Secours Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Mc
Jerusalem, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Meir Medical Center
Kefar Sava, , Israel
Akershus University Hospital
Lorenskog, , Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim, , Norway
Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
Bydgoszcz, , Poland
Medical University of Gdansk
Gdansk, , Poland
Szpital Morski Im. Pck Sp. Z O.O
Gdynia, , Poland
University Public Hospital Nr 1
Lublin, , Poland
Oddzia Kliniczny Hematologii
Olsztyn, , Poland
Pratia Poznan
Skórzewo, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
Wroclaw, , Poland
Coltea Clinical Hospital
Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, , Romania
Clinic For Hematology, University Clinical Center Serbia
Belgrade, , Serbia
Institute For Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Clinic of Hematology Clinical Center of Vojvodina
Novi Sad, , Serbia
Hacettepe University Cancer Institute Clinical Oncology Department
Ankara, , Turkey (Türkiye)
Gazi University Hospital Gazi University Faculty of Medicine
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Ozel Liv Hospital Onkoloji Klinigi
Ankara, , Turkey (Türkiye)
Vkf American Hospital
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim
Istanbul, , Turkey (Türkiye)
Ege University Hospital
Izmir, , Turkey (Türkiye)
Ercyes University Medical School
Kayseri, , Turkey (Türkiye)
Tekrda-Nk Tp Fakltesi
Merkez, , Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi
Yenimahalle, , Turkey (Türkiye)
Antrim Area Hospital Northern Health Social Care Trust
Antrim, , United Kingdom
Belfast Health and Social Care Trust, of Trust Headquarters
Belfast, , United Kingdom
Countries
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Related Links
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Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Other Identifiers
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2023-505579-53-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCMOR 0208-305
Identifier Type: -
Identifier Source: org_study_id
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