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Large B-Cell LymphomaPhase 3firmMINDNCT05429268

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

A Phase 3 study testing Tafasitamab and Lenalidomide in people with Large B-Cell Lymphoma and Diffuse Large B-Cell Lymphoma, run by Incyte Corporation at 61 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Tafasitamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
61 sitesin 14 countries
Study dates
23 Dec 2022to 1 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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,

Who cannot join

  • 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:
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  • 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.
  • 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:
  • Known seropositive for or history of active viral infection with HIV.
  • Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
  • 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

Trial locations and contacts

61 sites in 14 countries.

61 sites in 14 countries

Turkey (Türkiye)11 sites

  • Hacettepe University Cancer Institute Clinical Oncology Department

    Ankara, 06230

  • Gazi University Hospital Gazi University Faculty of Medicine

    Ankara, 06560

  • Ankara University Medical Faculty

    Ankara, 06629

  • Ozel Liv Hospital Onkoloji Klinigi

    Ankara, 06680

  • Tekrda-Nk Tp Fakltesi

    Center, 59030

  • Vkf American Hospital

    Istanbul, 34365

  • Marmara Universitesi Pendik Egitim

    Istanbul, 34899

  • Ege University Hospital

    Izmir, 35040

  • Ercyes University Medical School

    Kayseri, 38039

  • Mersin University Medical Faculty

    Mersin, 33000

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

    Yenimahalle, 06200

Other trials in Turkey (Türkiye)

Poland8 sites

  • Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela

    Bydgoszcz, 85-168

  • Medical University of Gdansk

    Gdansk, 80-211

  • Szpital Morski Im. Pck Sp. Z O.O

    Gdynia, 81-519

  • University Public Hospital Nr 1

    Lublin, 20-081

  • Oddzia Kliniczny Hematologii

    Olsztyn, 10-228

  • Pratia Poznan

    Skórzewo, 60-185

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-0781

  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-367

Other trials in Poland

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 01088

  • National Institute of Oncology

    Budapest, 01122

  • University of Debrecen

    Debrecen, 04032

  • Markhot Ferenc Korhaz

    Eger, 03300

  • Somogy Medyei Kaposi Mor Oktato Korhaz

    Kaposvár, 07400

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Szeged, 06725

Other trials in Hungary

Bulgaria5 sites

  • Medical University Plovdiv

    Plovdiv, 04000

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407

  • Umhat Alexandrovska Sofia

    Sofia, 01431

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431

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

    Sofia, 01756

Other trials in Bulgaria

Finland5 sites

  • Helsinki University Central Hospital

    Helsinki, FI-00029

  • Kuopio University Hospital

    Kuopio, 70210

  • Oulu University Hospital

    Oulu, 90420

  • Tampere University Hospital

    Tampere, 33520

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Israel4 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Shaare Zedek Mc

    Jerusalem, 9103102

  • Hadassah University Hospital

    Jerusalem, 92210

  • Meir Medical Center

    Kefar Sava, 44281

Other trials in Israel

Romania4 sites

  • Coltea Clinical Hospital

    Bucharest, 30167

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

    Cluj-Napoca, 400015

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, 540136

Other trials in Romania

Serbia4 sites

  • Clinic For Hematology, University Clinical Center Serbia

    Belgrade, 11000

  • Institute For Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinic of Hematology Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Croatia3 sites

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Merkur

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Ireland3 sites

  • Bon Secours Hospital

    Cork, T12 DV56

  • Mater Misericordiae University Hospital

    Dublin, D07AX57

  • University Hospital Galway

    Galway, H91 YR71

Other trials in Ireland

Czechia2 sites

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00

  • Vseobecna Fakultni Nemocnice

    Prague, 128 00

Other trials in Czechia

Denmark2 sites

  • Aarhus University Hospital

    Aarhus, 08200

  • Odense University Hospital

    Odense, 05000

Other trials in Denmark

Norway2 sites

  • Akershus University Hospital

    Lorenskog, 01478

  • Universitetssykehuset I Trondheim - St. Olavs Hospital

    Trondheim, 07006

Other trials in Norway

United Kingdom2 sites

  • Antrim Area Hospital Northern Health Social Care Trust

    Antrim, BT41 2RL

  • Belfast Health and Social Care Trust, of Trust Headquarters

    Belfast, BT9 7AB

Other trials in United Kingdom

About this study

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

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).

Being tested
Tafasitamab, Lenalidomide
Keywords
MOR00208, INCMOR00208, tafasitamab, lenalidomide, firmMIND, Diffuse Large B-Cell Lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafasitamabDrug

    Also called INCMOR00208, MOR00208

    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.

  • LenalidomideDrug

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

Study groups in NCT05429268
Study groupRoleWhat they receive
Tafasitamab and LenalidomideExperimentalTafasitamab 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.
Receives: Drug: Tafasitamab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 24 months

Secondary outcomes (6)

  1. 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.

    Measured: Approximately 24 months

  2. 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.

    Measured: Approximately 24 months

  3. Disease Control Rate (DCR)

    Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.

    Measured: Approximately 24 months

  4. 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.

    Measured: Approximately 24 months

  5. Overall Survival (OS)

    Defined as the time from the date of first dose until death due to any cause.

    Measured: Approximately 24 months

  6. 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.

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start23 Dec 2022
  3. Primary completion30 Mar 2026
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, open-label, multicenter
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05429268
Sponsor's protocol ID
INCMOR 0208-305
Other IDs
2023-505579-53-00, 2023
Acronym
firmMIND
Status last verified
Oct 2026
First submitted
17 Jun 2022
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tafasitamab and Lenalidomide in people with Large B-Cell Lymphoma and Diffuse Large B-Cell Lymphoma, run by Incyte Corporation at 61 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Turkey (Türkiye), Poland, Hungary, Bulgaria, Finland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05429268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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