Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to tackle tough lymphoma

NCT ID NCT05222555

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a modified intravenous dosing schedule of tafasitamab combined with oral lenalidomide in 53 adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for a stem cell transplant. The main goal is to evaluate safety and how the drug moves through the body, with a secondary focus on tumor response. It is an early-phase, open-label trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafasitamab (a targeted antibody) and lenalidomide (an immune-modulating drug)
What this could lead to
If successful, this could offer a new treatment option for people with relapsed or refractory diffuse large B-cell lymphoma who cannot have a stem cell transplant.
What could go wrong
This is an early-phase trial with only 53 participants, so results may not apply broadly. Side effects from the drug combination could be significant, and the modified dosing may not improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

53 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Nov 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.

Major Inclusion Criteria: 1. Capable of giving signed informed consent 2. Age 18 years or older 3. Histologically confirmed diagnosis of DLBCL 4. Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study. 5. Patients must have: * relapsed and/or refractory disease * at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline) * received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy * Eastern Cooperative Oncology Group 0 to 2 6. Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT 7. Patients must meet the following laboratory criteria at screening: * absolute neutrophil count ≥1.5 × 10\^9/L * platelet count ≥90 × 10\^9/L * total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma * alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement * serum creatinine clearance ≥ 60 mL/minute 8. Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy 9. Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy) Major Exclusion Criteria: 1. Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study 2. Patients who have: * other histological type of lymphoma * a history of "double/triple hit" genetics 3. Patients who have, within 14 days prior to Day 1 dosing: * not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy * undergone major surgery (with 4 weeks) or suffered from significant traumatic injury * received live vaccines (within 4 weeks). * required parenteral antimicrobial therapy for active, intercurrent infections 4. Patients who: * have not recovered sufficiently from the adverse toxic effects of prior therapies * were previously treated with IMiDs® (e.g. thalidomide, LEN) * have history of hyper sensitivity to compounds of similar biological or chemical composition to tafasitamab IMiDs® and/or the excipients contained in the study treatment formulations * have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form. * have undergone previous allogenic stem cell transplantation * have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period * concurrently use other anticancer or experimental treatments 5. History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \>2 years prior to enrollment are eligible * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible 6. Patients with: * positive hepatitis B and/or C serology. * known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV) * CNS lymphoma involvement * history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent * history or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption * gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication * history or evidence of severe hepatic impairment (total serum bilirubin \> 3mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma * history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class * any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study 7. Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diffuse large B cell lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma relapsed/refractory diffuse 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

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

    Milan, Lombardy, 20162, Italy

  • ASST di Monza - Azienda Ospedaliera San Gerardo

    Monza, Monza E Brianza, 20900, Italy

  • Asan Medical Center - PPDS

    Seoul, 5505, South Korea

  • Azienda Ospedaliera di Perugia

    Perugia, Umbria, 6122, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56127, Italy

  • CHU Nantes

    Nantes, Loire-Atlantique, 44000, France

  • CHU de Poitiers

    Poitiers, Vienne, 86021, France

  • Centre Hospitalier Le Mans

    Le Mans, Sarthe, 72000, France

  • Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

    Grenoble, Isère, 38043, France

  • Centrum Medyczne Poznan - PRATIA - PPDS

    Skórzewo, Greater Poland Voivodeship, 60-185, Poland

  • Chonbuk National University Hospital

    Jeonju, 54907, South Korea

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 37007, Spain

  • Daegu Catholic University Medical Center

    Daegu, 42472, South Korea

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

  • Dong-A University Medical Center

    Busan, 49201, South Korea

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, Lombardy, 27100, Italy

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    Candiolo, Piedmont, 10060, Italy

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Hadassah Medical Center - Hadassah Ein Kerem

    Jerusalem, 91120, Israel

  • Hanyang University Medical Center

    Seoul, 4763, South Korea

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 7198, Spain

  • Hospital U. Infanta Leonor

    Madrid, 28031, Spain

  • Hospital U. Quironsalud Madrid

    Madrid, 28223, Spain

  • Hospital U. Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital U. Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitari La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 8907, Spain

  • Institut Catala d'Oncologia Girona

    Girona, 17007, Spain

  • Klinikum Wels Grieskirchen

    Wels, Upper Austria, 4600, Austria

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Lady Davis Carmel Medical Center

    Haifa, 34362, Israel

  • MD Anderson Madrid

    Madrid, 28033, Spain

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07960-6459, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Nasz Lekarz Osrodek Badan Klinicznych

    Torun, 87-100, Poland

  • Ospedale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48121, Italy

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship, 30-510, Poland

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501, Poland

  • SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228, Poland

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300, Israel

  • Soroka University Medical Centre

    Beersheba, Southern District, 84101, Israel

  • Szpital Wojewodzki w Opolu

    Opole, Opole Voivodeship, 45-061, Poland

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, 81-519, Poland

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

    Dallas, Texas, 75246-2092, United States

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido, 16247, South Korea

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, 7345, South Korea

  • UK St. Pölten

    Sankt Pölten, Lower Austria, 3100, Austria

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • Universitatsklinikum Salzburg

    Salzburg, 5020, Austria

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

  • Vista Oncology

    Olympia, Washington, 98506, United States

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 128 08, Czechia

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513, Poland

  • Yeungnam University Hospital

    Daegu, 42415, South Korea

  • ZIV Medical Center

    Safed, 13100, Israel

More trials for these conditions

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