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Clinical Trial NCT05429268 (firmMIND) for Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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) Phase 3 82

Active, not recruiting
Clinical Trial NCT05429268 (firmMIND) is designed to study Treatment for Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma. It is a Phase 3 interventional study that is active, not recruiting, having started on 23 December 2022, with plans to enroll 82 participants. Led by Incyte Corporation, it is expected to complete by 1 April 2027. The latest data from ClinicalTrials.gov was last updated on 10 December 2025.
Brief 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).
Official Title

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Conditions
Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma
Other Study IDs
  • firmMIND
  • INCMOR 0208-305
  • 2023-505579-53-00 (Registry Identifier) (EU CT Number)
NCT ID Number
NCT05429268
Start Date (Actual)
2022-12-23
Last Update Posted
2025-12-10
Completion Date (Estimated)
2027-04-01
Enrollment (Estimated)
82
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Keywords
MOR00208
INCMOR00208
tafasitamab
lenalidomide
firmMIND
Diffuse Large B-Cell Lymphoma
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTafasitamab 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Response Rate (ORR)
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Approximately 24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Duration of Response (DOR)
Defined as the time from the first documented CR or PR until the date of first documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per Independent Review Committee (IRC) assessment and investigator's assessment.
Approximately 24 months
Progression Free Survial (PFS)
Defined as the time from the date of first dose until the first documented disease progression, or death due to any cause, whichever occurs first per IRC assessment and investigator's assessment.
Approximately 24 months
Disease Control Rate (DCR)
Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.
Approximately 24 months
Time to Next Treatment (TTNT)
Defined as the time from first dose until the initiation of new anticancer therapy or death due to any reason, whichever occurs first.
Approximately 24 months
Overall Survival (OS)
Defined as the time from the date of first dose until death due to any cause.
Approximately 24 months
Number of treatment-emergent adverse events
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Approximately 24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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 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,

  • Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid 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 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
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61 Study Locations in 14 Countries
Medical University Plovdiv, Plovdiv, 04000, Bulgaria
Acibadem Cityclinica Mhat Tokuda, Sofia, 01407, Bulgaria
Umhat Alexandrovska Sofia, Sofia, 01431, Bulgaria
Umhat Sv. Ivan Rilski Ead, Sofia, 01431, Bulgaria
Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood, Sofia, 01756, Bulgaria
Clinical Hospital Dubrava, Zagreb, 10000, Croatia
Clinical Hospital Merkur, Zagreb, 10000, Croatia
University Hospital Centre Zagreb, Zagreb, 10000, Croatia
Fakultni Nemocnice Olomouc, Olomouc, 779 00, Czechia
Vseobecna Fakultni Nemocnice, Prague, 128 00, Czechia
Aarhus University Hospital, Aarhus, 08200, Denmark
Odense University Hospital, Odense, 05000, Denmark
Helsinki University Central Hospital, Helsinki, FI-00029, Finland
Kuopio University Hospital, Kuopio, 70210, Finland
Oulu University Hospital, Oulu, 90420, Finland
Tampere University Hospital, Tampere, 33520, Finland
Turku University Hospital, Turku, 20520, Finland
Semmelweis Egyetem, Budapest, 01088, Hungary
National Institute of Oncology, Budapest, 01122, Hungary
University of Debrecen, Debrecen, 04032, Hungary
Markhot Ferenc Korhaz, Eger, 03300, Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz, Kaposvár, 07400, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Szeged, 06725, Hungary
Bon Secours Hospital, Cork, T12 DV56, Ireland
Mater Misericordiae University Hospital, Dublin, D07AX57, Ireland
University Hospital Galway, Galway, H91 YR71, Ireland
Rambam Health Care Campus, Haifa, 31096, Israel
Shaare Zedek Mc, Jerusalem, 9103102, Israel
Hadassah University Hospital, Jerusalem, 92210, Israel
Meir Medical Center, Kefar Sava, 44281, Israel
Akershus University Hospital, Lorenskog, 01478, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital, Trondheim, 07006, Norway
Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela, Bydgoszcz, 85-168, Poland
Medical University of Gdansk, Gdansk, 80-211, Poland
Szpital Morski Im. Pck Sp. Z O.O, Gdynia, 81-519, Poland
University Public Hospital Nr 1, Lublin, 20-081, Poland
Oddzia Kliniczny Hematologii, Olsztyn, 10-228, Poland
Pratia Poznan, Skórzewo, 60-185, Poland
Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, 02-0781, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego, Wroclaw, 50-367, Poland
Coltea Clinical Hospital, Bucharest, 30167, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca, Cluj-Napoca, 400015, Romania
Institutul Regional de Oncologie Iasi, Iași, 700483, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Târgu Mureş, 540136, Romania
Clinic For Hematology, University Clinical Center Serbia, Belgrade, 11000, Serbia
Institute For Pulmonary Diseases of Vojvodina, Kamenitz, 21204, Serbia
Clinical Center Kragujevac, Kragujevac, 34000, Serbia
Clinic of Hematology Clinical Center of Vojvodina, Novi Sad, 21000, Serbia
Hacettepe University Cancer Institute Clinical Oncology Department, Ankara, 06230, Turkey (Türkiye)
Gazi University Hospital Gazi University Faculty of Medicine, Ankara, 06560, Turkey (Türkiye)
Ankara University Medical Faculty, Ankara, 06629, Turkey (Türkiye)
Ozel Liv Hospital Onkoloji Klinigi, Ankara, 06680, Turkey (Türkiye)
Tekrda-Nk Tp Fakltesi, Center, 59030, Turkey (Türkiye)
Vkf American Hospital, Istanbul, 34365, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim, Istanbul, 34899, Turkey (Türkiye)
Ege University Hospital, Izmir, 35040, Turkey (Türkiye)
Ercyes University Medical School, Kayseri, 38039, Turkey (Türkiye)
Mersin University Medical Faculty, Mersin, 33000, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi, Yenimahalle, 06200, Turkey (Türkiye)
Antrim Area Hospital Northern Health Social Care Trust, Antrim, BT41 2RL, United Kingdom
Belfast Health and Social Care Trust, of Trust Headquarters, Belfast, BT9 7AB, United Kingdom