Study on the Effectiveness and Safety of Odronextamab Compared to Standard Treatment in Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called B-cell non-Hodgkin’s lymphoma, which is a cancer that affects the lymphatic system, part of the body’s immune system. The study is evaluating a new treatment called odronextamab (also known by its code name REGN1979), which is a special type of medication known as a bispecific antibody. This means it is designed to target two different proteins at once, potentially helping the immune system to better fight the cancer. The trial aims to compare the effectiveness and safety of odronextamab against the standard treatments currently used for this type of cancer.

Participants in the study will receive either odronextamab or one of the standard treatments, which may include medications like cisplatin, gemcitabine, carboplatin, dexamethasone, cytarabine, rituximab, etoposide, or ifosfamide. These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will last for several months, during which participants will be closely monitored by healthcare professionals to assess how well the treatments are working and to check for any side effects.

The main goal of the study is to see how long participants can live without their cancer getting worse, which is known as event-free survival. Other aspects being studied include how long participants live overall, how their quality of life changes, and how their bodies respond to the treatments. This information will help researchers understand if odronextamab could be a better option for treating aggressive B-cell non-Hodgkin’s lymphoma compared to the current standard treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of aggressive B-cell non-Hodgkin’s lymphoma and ensuring the availability of tumor tissue for analysis.

The assessment also checks for measurable disease through imaging tests and evaluates overall health status, including organ function and performance status.

2 treatment assignment

Participants are randomly assigned to receive either odronextamab or standard of care treatment. The assignment is open-label, meaning both the participant and the healthcare provider know which treatment is being administered.

3 treatment phase

For those receiving odronextamab, the medication is administered intravenously. The specific dosage and frequency are determined by the study protocol and the healthcare provider.

Participants receiving standard of care may be treated with a combination of medications such as cisplatin, gemcitabine, carboplatin, dexamethasone, cytarabine, rituximab, etoposide, and ifosfamide. These are also administered intravenously, except for dexamethasone, which is taken orally.

4 monitoring and follow-up

Throughout the treatment, regular monitoring is conducted to assess the effectiveness and safety of the therapy. This includes imaging tests to evaluate tumor response and blood tests to monitor health status.

Participants are also monitored for any side effects or adverse reactions to the treatment.

5 end of treatment evaluation

At the end of the treatment phase, a comprehensive evaluation is performed to determine the overall response to the therapy. This includes assessing event-free survival and other outcomes as defined by the study protocol.

Participants may continue to be monitored for long-term outcomes and any late-onset side effects.

Who Can Join the Study?

The patient must have a type of cancer called B-Cell Non-Hodgkin’s Lymphoma, which is confirmed by a test called a histological test. This means a sample of the tumor is examined under a microscope.
The patient must have tumor tissue available for testing in a central laboratory. This can be a new sample or an older one that was taken before joining the study.
The patient must have cancer that either did not respond to the first treatment or came back within 12 months after starting the first treatment. The first treatment should have included a specific type of medicine called an anti-CD20 antibody and another type called an anthracycline.
The patient must have a tumor that can be measured. This means there is at least one lymph node with a size greater than 1.5 cm or another type of tumor with a size greater than 1.0 cm, as shown by a scan like a CT scan or MRI.
The patient should plan to have a procedure called an Autologous stem cell transfer, which is a treatment that uses the patient’s own stem cells.
The patient must have an ECOG performance status of 0 to 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must have adequate blood and organ function, meaning their blood and organs are working well enough to participate in the study.
Other specific criteria defined in the study protocol may also apply.
The study is open to both male and female patients.

Who Cannot Join the Study?

Patients who have a different type of cancer other than B-Cell Non-Hodgkin’s Lymphoma cannot participate. This is a specific type of cancer that affects certain white blood cells called B-cells.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other medical conditions that might interfere with the study or make it unsafe for them to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Institut Jules Bordet	Anderlecht	Belgium
University Of Debrecen	Debrecen	Hungary
Spitalul Clinic Coltea	Bucharest	Romania
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Semmelweis University	Budapest	Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
University Of Pecs	Pecs	Hungary
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Klinikum Frankfurt (Oder) GmbH	Frankfurt (oder)	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Spaarne Gasthuis	Hoofddorp	The Netherlands
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Ospedale S. Eugenio	Rome	Italy
CHU UCL Namur	Yvoir	Belgium
Ixsflzrc Rftwqnylt Phd Le Spwejc Dvw Tskykb Dlum Afgysnq Ibeq Smlawj	Meldola	Italy
Snvsboncxbwkeda Kmbiuunkcvvisejhbepgpczphdmu mtiabs Ljg Hwfprswrrrgzhi Sghjowks Lcinnr	Leoben	Austria
Hlt Zbsuiwfwzueudlfhg Ahozvdivg	Antwerp	Belgium
Cntekwh Uikduquyixk Ds Nvvcdco	Madrid	Spain
Epeslle Uagaavlsfyoj Mbninfq Ctfvkcu Rsvjqcmeo (pounfyc Mjp	Rotterdam	The Netherlands
Airzjal Ocyqjxyccbl Uskujekcazter Ssttxh	Siena	Italy
Jmuxickx Kigbip Ulghdyxrbq	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	16.06.2023
Belgium	Not recruiting	16.06.2023
Czechia	Not recruiting	16.06.2023
Germany	Not recruiting	16.06.2023
Hungary	Not yet recruiting	16.06.2023
Italy	Not recruiting	16.06.2023
Poland	Not recruiting	16.06.2023
Romania	Not recruiting	16.06.2023
Spain	Not recruiting	16.06.2023
The Netherlands	Not recruiting	16.06.2023

Trial locations

Investigated drugs:

Odronextamab (REGN1979) is a bispecific antibody designed to target two proteins, CD20 and CD3. It is used in this trial to treat patients with aggressive B-cell non-Hodgkin lymphoma that has either returned after treatment or has not responded to previous treatments. The medication works by helping the immune system recognize and attack the cancer cells more effectively.

Standard of Care Therapy refers to the usual treatment given for aggressive B-cell non-Hodgkin lymphoma. This can include a variety of chemotherapy drugs, targeted therapies, or other treatments that are commonly used and accepted by medical professionals to manage this type of cancer. The specific treatments used as standard care can vary depending on the patient’s previous treatments and overall health.

Investigated diseases:

Diffuse large B-cell lymphoma

B-Cell Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-lymphocytes, which are a type of white blood cell. It is characterized by the uncontrolled growth of these cells, leading to the formation of tumors in lymph nodes and other parts of the body. The disease can vary significantly in its progression, with some forms being slow-growing and others more aggressive. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can lead to the spread of cancerous cells to other organs and tissues. The exact cause of B-Cell Non-Hodgkin’s Lymphoma is not well understood, but it involves genetic mutations in the B-cells.

Trial ID:

2022-502783-21-00

Protocol code:

R1979-HM-2299

NCT ID:

NCT06230224

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Odronextamab Compared to Standard Treatment in Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?