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

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

6 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

AZD0486 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory B-cell Non-Hodgkin Lymphoma. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for AZD0486 is for patients with this specific type of lymphoma who have not responded to previous treatments. At the molecular level, AZD0486 works by targeting specific pathways involved in the growth and survival of cancer cells, aiming to inhibit their proliferation. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505789-27-00Estimated enrolment270 patientsSponsorAstraZeneca AB

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