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

NCT05429268 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCMOR 0208-3052023-505579-53-00
• Study Type: interventional
• Target: 82
• Locations: 14 countries
• Sites: 61

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).

Conditions

Diffuse Large B-Cell Lymphoma; Large B-Cell Lymphoma

Keywords

MOR00208; INCMOR00208; tafasitamab; lenalidomide; firmMIND; Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of Response (DOR)

  Approximately 24 months

• Progression Free Survial (PFS)

  Approximately 24 months

• Disease Control Rate (DCR)

  Approximately 24 months

• Time to Next Treatment (TTNT)

  Approximately 24 months

• Overall Survival (OS)

  Approximately 24 months

Study Arms (1)

Tafasitamab and Lenalidomide

EXPERIMENTAL

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.

Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

Tafasitamab and Lenalidomide

Tafasitamab DRUG

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.

Also known as: INCMOR00208, MOR00208

Tafasitamab and Lenalidomide

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed diagnosis of any of the following:
• Diffuse large B-cell lymphoma not otherwise specified
• T cell/histiocyte-rich large B-cell lymphoma
• Epstein-Barr virus positive DLBCL of the elderly
• Grade 3b follicular lymphoma
• Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
• 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,

You may not qualify if:

• Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including:
• primary mediastinal (thymic) large B-cell lymphoma,
• Burkitt lymphoma,
• Primary refractory diffuse large B-cell lymphoma (DLBCL),
• History of double- or triple-hit DLBCL.
• Participants who, within 30 days prior to Cycle 1 Day 1, have:
• Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
• Undergone major surgery or suffered from significant traumatic injury
• Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (61)

Medical University Plovdiv

Plovdiv, 04000, Bulgaria

Location

Acibadem Cityclinica Mhat Tokuda

Sofia, 01407, Bulgaria

Location

Umhat Alexandrovska Sofia

Sofia, 01431, Bulgaria

Location

Umhat Sv. Ivan Rilski Ead

Sofia, 01431, Bulgaria

Location

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

Sofia, 01756, Bulgaria

Location

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Location

Clinical Hospital Merkur

Zagreb, 10000, Croatia

Location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Fakultni Nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Vseobecna Fakultni Nemocnice

Prague, 128 00, Czechia

Location

Aarhus University Hospital

Aarhus, 08200, Denmark

Location

Odense University Hospital

Odense, 05000, Denmark

Location

Helsinki University Central Hospital

Helsinki, FI-00029, Finland

Location

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Oulu University Hospital

Oulu, 90420, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Semmelweis Egyetem

Budapest, 01088, Hungary

Location

National Institute of Oncology

Budapest, 01122, Hungary

Location

University of Debrecen

Debrecen, 04032, Hungary

Location

Markhot Ferenc Korhaz

Eger, 03300, Hungary

Location

Somogy Medyei Kaposi Mor Oktato Korhaz

Kaposvár, 07400, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Szeged, 06725, Hungary

Location

Bon Secours Hospital

Cork, T12 DV56, Ireland

Location

Mater Misericordiae University Hospital

Dublin, D07AX57, Ireland

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Shaare Zedek Mc

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital

Jerusalem, 92210, Israel

Location

Meir Medical Center

Kefar Sava, 44281, Israel

Location

Akershus University Hospital

Lorenskog, 01478, Norway

Location

Universitetssykehuset I Trondheim - St. Olavs Hospital

Trondheim, 07006, Norway

Location

Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela

Bydgoszcz, 85-168, Poland

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Szpital Morski Im. Pck Sp. Z O.O

Gdynia, 81-519, Poland

Location

University Public Hospital Nr 1

Lublin, 20-081, Poland

Location

Oddzia Kliniczny Hematologii

Olsztyn, 10-228, Poland

Location

Pratia Poznan

Skórzewo, 60-185, Poland

Location

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, 02-0781, Poland

Location

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

Wroclaw, 50-367, Poland

Location

Coltea Clinical Hospital

Bucharest, 30167, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu Mures

Târgu Mureş, 540136, Romania

Location

Clinic For Hematology, University Clinical Center Serbia

Belgrade, 11000, Serbia

Location

Institute For Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinic of Hematology Clinical Center of Vojvodina

Novi Sad, 21000, Serbia

Location

Hacettepe University Cancer Institute Clinical Oncology Department

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Hospital Gazi University Faculty of Medicine

Ankara, 06560, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06629, Turkey (Türkiye)

Location

Ozel Liv Hospital Onkoloji Klinigi

Ankara, 06680, Turkey (Türkiye)

Location

Tekrda-Nk Tp Fakltesi

Center, 59030, Turkey (Türkiye)

Location

Vkf American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim

Istanbul, 34899, Turkey (Türkiye)

Location

Ege University Hospital

Izmir, 35040, Turkey (Türkiye)

Location

Ercyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Mersin, 33000, Turkey (Türkiye)

Location

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

Yenimahalle, 06200, Turkey (Türkiye)

Location

Antrim Area Hospital Northern Health Social Care Trust

Antrim, BT41 2RL, United Kingdom

Location

Belfast Health and Social Care Trust, of Trust Headquarters

Belfast, BT9 7AB, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Oliver Manzke, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label, multicenter

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: December 23, 2022
• Primary Completion: March 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (11); PL (8); GB (2); CR (3); SE (4); NO (2); FI (5); BU (5); HU (6); DK (2); CZ (2); RO (4); IE (3); IL (4)