Study on the Safety and Effectiveness of Tafasitamab and Lenalidomide for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating the effects of a treatment combination that includes Tafasitamab and Lenalidomide. Tafasitamab is a humanized monoclonal antibody, which is a type of protein designed to target specific cells, and it is also known by the code name MOR00208. Lenalidomide is a medication that helps the immune system fight cancer and is taken in capsule form.

The purpose of this study is to evaluate the safety and effectiveness of this treatment combination in patients whose DLBCL has returned or has not responded to previous treatments. Participants in the study will receive the treatment over a period of up to 12 months. The study will monitor how well the treatment works and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups and tests to assess their response to the treatment. The study aims to provide valuable information on whether this combination of Tafasitamab and Lenalidomide can be a beneficial treatment option for patients with relapsed or refractory DLBCL. The results will help determine if this treatment can improve outcomes for patients with this challenging condition.

1 joining the study

Upon joining the study, the participant will be required to provide consent and confirm their understanding of the study procedures.

Eligibility will be confirmed through a review of medical history and necessary diagnostic tests.

2 initial assessments

Initial assessments will include a tumor biopsy and a bone marrow biopsy or aspirate collection, if applicable.

These assessments are necessary to confirm the diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).

3 treatment phase

The treatment involves the administration of two medications: tafasitamab and lenalidomide.

Tafasitamab will be given as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

Lenalidomide will be taken orally in the form of capsules. The dosage may vary, and the participant will be instructed on the correct dosage and schedule.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the participant’s response to the treatment.

This will include physical examinations, blood tests, and imaging studies as required by the study protocol.

The primary goal is to evaluate the overall response rate (ORR), which measures the percentage of participants achieving a complete or partial response.

5 end of treatment

Upon completion of the treatment phase, a final assessment will be conducted to determine the participant’s response.

The duration of response (DOR) will be evaluated, which is the time from the first documented complete or partial response until disease progression or death.

Who Can Join the Study?

Must be 18 years or older at the time of giving consent.
Must be able to understand and willing to sign a written Informed Consent Form (ICF), which is a document that explains the study and what is expected from participants.
Must have a confirmed diagnosis of one of the following types of Diffuse Large B-Cell Lymphoma (DLBCL):
- 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 and a subsequent DLBCL relapse
- Evidence of transformation from a low-grade lymphoma (like follicular lymphoma, marginal zone lymphoma, or chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
Must be willing to undergo a tumor biopsy, which is a procedure to remove a small sample of tissue for examination. This can be done through different methods like incisional, excisional, or core needle biopsy, or using a previous biopsy sample from the last 3 years.
Must be willing to undergo bone marrow biopsy/aspirate collections if needed. This involves taking a small sample of bone marrow, which is the soft tissue inside bones, to check for disease.

Who Cannot Join the Study?

Patients who have a different type of cancer than Diffuse large B-cell lymphoma (DLBCL).
Patients who are eligible for HDC/ASCT, which stands for high-dose chemotherapy and autologous stem cell transplant. This is a treatment where high doses of medicine are used to kill cancer cells, and then the patient’s own stem cells are given back to help the body recover.
Patients who do not meet the age requirements for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other medical conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medications.
Patients who have an active infection that requires treatment.
Patients who have a history of other serious diseases that might affect their participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
Bon Secours Hospital Cork	Cork	Ireland
Oulu University Hospital	Oulu	Finland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
KBC Zagreb	Zagreb	Croatia
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Spitalul Clinic Coltea	Bucharest	Romania
Institutul Regional De Oncologie Iasi	Iasi	Romania
Odense University Hospital	Odense	Denmark
Semmelweis University	Budapest	Hungary
University Hospital Galway	Galway	Ireland
Turku University Hospital	Turku	Finland
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Region Midtjylland	Aarhus	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
University Hospital Olomouc	Olomouc	Czechia
Pirkanmaan hyvinvointialue	Tampere	Finland
Emergency Institute For Cardiovascular Diseases And Transplant	Targu Mures	Romania
University Of Szeged	Szeged	Hungary
Specialized Hospital For Active Treatment Of Hematological Diseases EAD	Sofia	Bulgaria
Soodurqd Pveyqjkbj Sih z oxzj	Gdynia	Poland
Azroabru Ucjjjjblyd Hwqcnrdt	Lorenskog	Norway
Hqkhypur Uxcykcthmg Cwzpxck Hugjhesz	Helsinki	Finland
Nloutryv Illtpryf Oegjpzxbd Ilf Mzvbv Symbzeglliuzvkadxcwfbeearkiq Ilymkzpn Bhphwlrf	Cracow	Poland
Uefqxedczxeysa Cxkfmhz Kipqwoblw	Gdansk	Poland
Cihmiutj Hzmagtdj Dvpgejq	Zagreb	Croatia

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.07.2022
Croatia	Not recruiting	01.07.2022
Czechia	Not recruiting	01.07.2022
Denmark	Not recruiting	01.07.2022
Finland	Not recruiting	01.07.2022
Hungary	Not recruiting	01.07.2022
Ireland	Not recruiting	01.07.2022
Norway	Not recruiting	01.07.2022
Poland	Not recruiting	01.07.2022
Romania	Not recruiting	01.07.2022

Trial locations

Investigated drugs:

Tafasitamab is a medication used in this study to treat patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL). It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

Lenalidomide is another medication used in combination with tafasitamab in this study. It helps to boost the immune system and can also directly attack cancer cells. This combination aims to improve the treatment outcomes for patients with relapsed or refractory DLBCL who are not suitable for high-dose chemotherapy or stem cell transplant.

Investigated diseases:

Non-Hodgkin's lymphoma

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. DLBCL can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. The disease can progress quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma and can occur at any age, though it is more frequently diagnosed in older adults. The progression of DLBCL can vary, with some cases responding well to treatment while others may be more challenging to manage.

Trial ID:

2023-505579-53-00

Protocol code:

INCMOR 0208-305

NCT ID:

NCT05429268

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Tafasitamab and Lenalidomide for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

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