Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

Last updated: July 3, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma, B-cell

Hematologic Cancer

Lymphoma

Treatment

Lenalidomide

Tafasitamab

Clinical Study ID

NCT05429268
INCMOR 0208-305
2023-505579-53-00
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically-confirmed diagnosis of any of the following:
  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 gradelymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zonelymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCLrelapse

  • Willingness to undergo tumor biopsy requirements for the study, (or have archivallymph node or tissue block from the most recent biopsy, not to exceed 3 years priorto C1D1).

  • Willingness to undergo bone marrow biopsy/aspirate collections.

  • History of relapsed/progressive/recurrent disease according to the InternationalWorking 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

Exclusion Criteria:

  • Any other histological type of lymphoma according to the WHO 2016 classification oflymphoid neoplasms, including:
  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 whilereceiving 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 complicationsfrom major surgery before Cycle 1 Day 1.

  • Have a history of deep venous thrombosis/embolism, threatening thromboembolism orknown thrombophilia or are at high risk for a thromboembolic event in the opinion ofthe investigator and who are not willing/able to take venous thromboembolic eventprophylaxis during the entire treatment period.

  • Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 yearsprior to screening.

  • Clinically significant cardiac disease, including unstable angina, acute myocardialinfarction, 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) anda positive test result for HCV RNA.

  3. Known positive test results for chronic HBV infection (defined by HBsAgpositivity). Participants with occult or prior HBV infection (defined asnegative HBsAg and positive total HBcAb) may be included if HBV DNA wasundetectable

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: Lenalidomide
Phase: 3
Study Start date:
December 23, 2022
Estimated Completion Date:
April 01, 2027

Connect with a study center

  • Medical University Plovdiv

    Plovdiv, 04000
    Bulgaria

    Site Not Available

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407
    Bulgaria

    Site Not Available

  • Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood

    Sofia, 01756
    Bulgaria

    Site Not Available

  • Umhat Alexandrovska Sofia

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Clinical Hospital Dubrava

    Zagreb, 10000
    Croatia

    Site Not Available

  • Clinical Hospital Merkur

    Zagreb, 10000
    Croatia

    Site Not Available

  • University Hospital Centre Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice

    Prague 2, 128 00
    Czechia

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 08200
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 05000
    Denmark

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, FI-00029
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio, 70210
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu, 90420
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere, 33520
    Finland

    Site Not Available

  • Turku University Hospital

    Turku, 20520
    Finland

    Site Not Available

  • National Institute of Oncology

    Budapest, 01122
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 01088
    Hungary

    Site Not Available

  • University of Debrecen

    Debrecen, 04032
    Hungary

    Site Not Available

  • Markhot Ferenc Hospital

    Eger, 03300
    Hungary

    Site Not Available

  • Markhot Ferenc Korhaz

    Eger, 03300
    Hungary

    Site Not Available

  • Somogy Medyei Kaposi Mor Oktato Korhaz

    Kaposvar, 07400
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Szeged, 06725
    Hungary

    Site Not Available

  • Bon Secours Hospital

    Cork, T12 DV56
    Ireland

    Site Not Available

  • Mater Misericordiae University Hospital

    Dublin 7, D07AX57
    Ireland

    Site Not Available

  • University Hospital Galway

    Galway, H91 YR71
    Ireland

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 31096
    Israel

    Site Not Available

  • Hadassah University Hospital

    Jerusalem, 92210
    Israel

    Site Not Available

  • Shaare Zedek Mc

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Meir Medical Center

    Kefar Sava, 44281
    Israel

    Site Not Available

  • Akershus University Hospital

    Lorenskog, 01478
    Norway

    Site Not Available

  • Akershus University Hospital

    Nordbyhagen, 01478
    Norway

    Site Not Available

  • Akershus University Hospital

    Oslo, 1478
    Norway

    Site Not Available

  • Universitetssykehuset I Trondheim - St. Olavs Hospital

    Trondheim, 07006
    Norway

    Site Not Available

  • Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Medical University of Gdansk

    Gdansk, 80-211
    Poland

    Site Not Available

  • Szpital Morski Im. Pck Sp. Z O.O

    Gdynia, 81-519
    Poland

    Site Not Available

  • University Public Hospital Nr 1

    Lublin, 20-081
    Poland

    Site Not Available

  • Oddzia Kliniczny Hematologii

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Pratia Poznan

    Skorzewo K. Poznania, 60-185
    Poland

    Site Not Available

  • Pratia Poznan

    Skórzewo, 60-185
    Poland

    Site Not Available

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warszawa, 02-0781
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Coltea Clinical Hospital

    Bucharest, 30167
    Romania

    Site Not Available

  • Coltea Clinical Hospital

    Bucureti, 30167
    Romania

    Site Not Available

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-napoca, 400015
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi

    Iasi, 700483
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Targu Mures, 540136
    Romania

    Site Not Available

  • Clinic For Hematology, University Clinical Center Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinic of Hematology Clinical Center of Vojvodina

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Institute For Pulmonary Diseases of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 06629
    Turkey

    Site Not Available

  • Gazi University Hospital Gazi University Faculty of Medicine

    Ankara, 06560
    Turkey

    Site Not Available

  • Hacettepe University Cancer Institute Clinical Oncology Department

    Ankara, 06230
    Turkey

    Site Not Available

  • Ozel Liv Hospital Onkoloji Klinigi

    Ankara, 06680
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim

    Istanbul, 34899
    Turkey

    Site Not Available

  • Vkf American Hospital

    Istanbul, 34365
    Turkey

    Site Not Available

  • Ege University Hospital

    Izmir, 35040
    Turkey

    Site Not Available

  • Ercyes University Medical School

    Kayseri, 38039
    Turkey

    Site Not Available

  • Tekrda-Nk Tp Fakltesi

    Merkez, 59030
    Turkey

    Site Not Available

  • Mersin University Medical Faculty

    Mersin, 33000
    Turkey

    Site Not Available

  • Hacettepe University Cancer Inst?Tute Clinical Oncology Department

    Sihhiye, 06230
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim

    Stanbul, 34899
    Turkey

    Site Not Available

  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital

    Yenimahalle, 06200
    Turkey

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi

    Yenimahalle, 06200
    Turkey

    Site Not Available

  • Antrim Area Hospital Northern Health Social Care Trust

    Antrim, BT41 2RL
    United Kingdom

    Site Not Available

  • Belfast Health and Social Care Trust, of Trust Headquarters

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

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