Study on the Effectiveness and Safety of AZD0486 for Adults with Relapsed or Refractory Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of blood cancer known as Non-Hodgkin Lymphoma, specifically in cases where the disease has returned or has not responded to previous treatments. The trial will test a new treatment called AZD0486, which is a special type of medicine known as a monoclonal antibody. This medicine is designed to target specific proteins on the surface of cancer cells, helping the body’s immune system to fight the cancer more effectively.

The purpose of the study is to learn how well AZD0486 works and how safe it is for patients with this type of cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine will be given directly into a vein. The study will follow participants over time to see how their cancer responds to the treatment and to monitor any side effects they might experience.

Throughout the study, researchers will collect information on how the treatment affects the cancer and the overall health of the participants. This includes looking at changes in the size of the cancer, any improvements in symptoms, and any side effects that occur. The study aims to provide valuable information that could lead to new treatment options for people with Non-Hodgkin Lymphoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18 to 80 years, checking the performance status, and confirming a diagnosis of relapsed or refractory B-cell non-Hodgkin lymphoma.

Additional tests ensure adequate liver, blood, kidney, and heart function. The disease must be measurable and show activity on specific scans.

2 treatment administration

The treatment involves receiving AZD0486, a solution for infusion. This medication is a type of antibody that targets specific proteins on cancer cells.

The medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein.

3 monitoring and follow-up

Regular monitoring is conducted to assess the treatment’s effectiveness and safety. This includes tracking any side effects, changes in laboratory results, vital signs, and heart activity.

The primary goal is to determine the overall response rate, which measures how well the cancer responds to the treatment.

4 evaluation of outcomes

Secondary outcomes are evaluated, including the duration of response, time to response, and overall survival rates.

Additional assessments include the study of drug levels in the body, immune response to the drug, and patient-reported outcomes related to fatigue, pain, and cognitive effects.

Who Can Join the Study?

Participant must be between 18 and 80 years old at the time of signing the informed consent form.
Participant must have an ECOG performance status of 0 to 2. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means the person is up and about more than half of waking hours.
Participant must have relapsed or refractory disease after at least 2 previous treatments. “Relapsed” means the disease has returned after treatment, and “refractory” means the disease did not respond to treatment.
Participant must have a confirmed diagnosis of B-NHL (B-cell Non-Hodgkin Lymphoma) based on a local pathology report, following the WHO 2017 classification.
Participant must have FDG-avid and measurable disease. This means the disease can be detected using a special imaging test that shows areas of high glucose uptake, which is common in cancer cells.
Participant must have adequate liver, blood, kidney, and heart function. This means these organs are working well enough to safely participate in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than Non-Hodgkin Lymphoma cannot participate. Non-Hodgkin Lymphoma is a type of cancer that starts in the lymphatic system, which is part of the body’s immune system.
Patients who have not experienced a return of their cancer (relapsed) or whose cancer has not stopped responding to treatment (refractory) are not eligible.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study organizers.
Patients who are not male or female cannot participate, as the study is open to both genders.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may have additional risks or needs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Centre Henri Becquerel	Rouen	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Uzfutiitsxszrdjogxnvg Eqlha Acp	Essen	Germany
Agltwzj Oertgxlxvkv Nuelxrnad Sv Aumdgrg E Bhngeg E C Aqmywc Auljnrnfkix	Alexandria	Italy
Usrgxqivlyqeelkdewucz Wamndeswa Aub	Wuerzburg	Germany
Apvcgfe Uxpwy Sxqvzkaqi Lhhshy Dh Bzysdgk	Bologna	Italy
Udbqtvsqyy Dxpkw Sraiz Dy Rcev Lz Sdekbkzs	Rome	Italy
Hzionjlb Vbmw dtvgtnxy	Barcelona	Spain
Aaknhua Swoxt Sjcjnefrr Thuiarihtbud Dvgmq Vzntx Oyowq	Saronno	Italy

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	27.03.2025
France	Recruiting	27.03.2025
Germany	Recruiting	27.03.2025
Italy	Recruiting	27.03.2025
Spain	Recruiting	27.03.2025
Sweden	Recruiting	27.03.2025

Trial locations

AZD0486 is an investigational medication being studied for its effectiveness and safety in treating patients with B-cell Non-Hodgkin Lymphoma that has either returned after treatment or has not responded to previous treatments. This medication is being tested to see how well it works on its own in helping to manage this type of cancer.

Relapsed or Refractory Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. “Relapsed” refers to the return of the disease after treatment, while “refractory” indicates that the disease does not respond to treatment. The progression of this disease can vary, with some cases advancing slowly and others more rapidly. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can affect various organs and tissues, depending on where the cancerous cells spread.

Trial ID:

2023-505789-27-00

NCT ID:

NCT06526793

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of AZD0486 for Adults with Relapsed or Refractory Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?