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New drug duo offers hope for Hard-to-Treat lymphoma patients

NCT ID NCT05429268

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, tafasitamab and lenalidomide, in adults with diffuse large B-cell lymphoma that has come back or not responded to prior treatments. Participants have had 1 to 3 previous therapies but cannot receive high-dose chemo or a stem cell transplant. The main goal is to see how many patients have their tumors shrink or disappear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

82 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: * 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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Conditions

The condition(s) this trial relates to.

composite lymphoma diffuse large B-cell lymphoma Epstein-Barr virus-positive diffuse large B-cell lymphoma of the elderly follicular lymphoma large B-cell lymphoma T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma Large B-cell lymphoma

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, 08200, Denmark

  • Acibadem Cityclinica Mhat Tokuda

    Sofia, 01407, Bulgaria

  • Akershus University Hospital

    Lorenskog, 01478, Norway

  • Ankara University Medical Faculty

    Ankara, 06629, Turkey (Türkiye)

  • Antrim Area Hospital Northern Health Social Care Trust

    Antrim, BT41 2RL, United Kingdom

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Szeged, 06725, Hungary

  • Belfast Health and Social Care Trust, of Trust Headquarters

    Belfast, BT9 7AB, United Kingdom

  • Bon Secours Hospital

    Cork, T12 DV56, Ireland

  • Clinic For Hematology, University Clinical Center Serbia

    Belgrade, 11000, Serbia

  • Clinic of Hematology Clinical Center of Vojvodina

    Novi Sad, 21000, Serbia

  • Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • Clinical Hospital Dubrava

    Zagreb, 10000, Croatia

  • Clinical Hospital Merkur

    Zagreb, 10000, Croatia

  • Coltea Clinical Hospital

    Bucharest, 30167, Romania

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

    Yenimahalle, 06200, Turkey (Türkiye)

  • Ege University Hospital

    Izmir, 35040, Turkey (Türkiye)

  • Ercyes University Medical School

    Kayseri, 38039, Turkey (Türkiye)

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Gazi University Hospital Gazi University Faculty of Medicine

    Ankara, 06560, Turkey (Türkiye)

  • Hacettepe University Cancer Institute Clinical Oncology Department

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah University Hospital

    Jerusalem, 92210, Israel

  • Helsinki University Central Hospital

    Helsinki, FI-00029, Finland

  • Institute For Pulmonary Diseases of Vojvodina

    Kamenitz, 21204, Serbia

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

    Cluj-Napoca, 400015, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Kuopio University Hospital

    Kuopio, 70210, Finland

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, 02-0781, Poland

  • Markhot Ferenc Korhaz

    Eger, 03300, Hungary

  • Marmara Universitesi Pendik Egitim

    Istanbul, 34899, Turkey (Türkiye)

  • Mater Misericordiae University Hospital

    Dublin, D07AX57, Ireland

  • Medical University Plovdiv

    Plovdiv, 04000, Bulgaria

  • Medical University of Gdansk

    Gdansk, 80-211, Poland

  • Meir Medical Center

    Kefar Sava, 44281, Israel

  • Mersin University Medical Faculty

    Mersin, 33000, Turkey (Türkiye)

  • National Institute of Oncology

    Budapest, 01122, Hungary

  • Oddzia Kliniczny Hematologii

    Olsztyn, 10-228, Poland

  • Odense University Hospital

    Odense, 05000, Denmark

  • Oulu University Hospital

    Oulu, 90420, Finland

  • Ozel Liv Hospital Onkoloji Klinigi

    Ankara, 06680, Turkey (Türkiye)

  • Pratia Poznan

    Skórzewo, 60-185, Poland

  • Rambam Health Care Campus

    Haifa, 31096, Israel

  • Semmelweis Egyetem

    Budapest, 01088, Hungary

  • Shaare Zedek Mc

    Jerusalem, 9103102, Israel

  • Somogy Medyei Kaposi Mor Oktato Korhaz

    Kaposvár, 07400, Hungary

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

    Sofia, 01756, Bulgaria

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, 540136, Romania

  • Szpital Morski Im. Pck Sp. Z O.O

    Gdynia, 81-519, Poland

  • Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela

    Bydgoszcz, 85-168, Poland

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Tekrda-Nk Tp Fakltesi

    Center, 59030, Turkey (Türkiye)

  • Turku University Hospital

    Turku, 20520, Finland

  • Umhat Alexandrovska Sofia

    Sofia, 01431, Bulgaria

  • Umhat Sv. Ivan Rilski Ead

    Sofia, 01431, Bulgaria

  • Universitetssykehuset I Trondheim - St. Olavs Hospital

    Trondheim, 07006, Norway

  • University Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • University Hospital Galway

    Galway, H91 YR71, Ireland

  • University Public Hospital Nr 1

    Lublin, 20-081, Poland

  • University of Debrecen

    Debrecen, 04032, Hungary

  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-367, Poland

  • Vkf American Hospital

    Istanbul, 34365, Turkey (Türkiye)

  • Vseobecna Fakultni Nemocnice

    Prague, 128 00, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.