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Study Comparing Loncastuximab Tesirine and Rituximab with Standard Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Verified siteRegistered drugNo 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 cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating the effectiveness of a new treatment combination. The treatment involves a medication called Loncastuximab Tesirine, also known by its code name ADCT-402, combined with another medication called Rituximab. These medications are compared to standard immunochemotherapy, which is a treatment that uses the body's immune system to fight cancer along with chemotherapy drugs.

The purpose of the study is to evaluate how well the combination of Loncastuximab Tesirine and Rituximab works compared to the usual treatment for patients whose DLBCL has returned after treatment or has not responded to previous treatments. The study will involve participants receiving these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with regular monitoring to assess the progress and any effects of the treatment.

Participants in the study will be randomly assigned to receive either the new treatment combination or the standard treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to provide valuable information on whether the new treatment combination can improve outcomes for patients with relapsed or refractory DLBCL.

The research process

The trial runs in 5 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 a review of medical history and a series of tests to ensure adequate organ function and measurable disease.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving the combination of loncastuximab tesirine and rituximab, and the other receiving standard immunochemotherapy.

  3. Step 3

    Treatment administration

    For those in the experimental group, loncastuximab tesirine is administered intravenously. Rituximab is also given intravenously. The specific dosage and frequency are determined by the study protocol.

    Participants in the control group receive standard immunochemotherapy, which may include medications such as dexamethasone (oral use), oxaliplatin, and gemcitabine (both intravenous use).

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and laboratory assessments.

    Follow-up visits are scheduled to track progression-free survival, which is the time between randomization and the first documentation of disease recurrence, progression, or death.

  5. Step 5

    Completion of study

    The study is estimated to conclude by February 2026. Participants will continue to be monitored for outcomes related to the primary endpoint of progression-free survival.

Who can join the trial?

14 criteria

  • Must be a male or female patient aged 18 years or older.
  • Women who can have children must agree to use a very effective birth control method from the time they agree to join the study until at least 12 months after their last dose of the study treatment. Men with female partners who can have children must agree to use a condom or not have sexual activity from the time they agree to join the study until at least 7 months after their last dose of the study treatment.
  • Must have a confirmed diagnosis of **Diffuse Large B-Cell Lymphoma (DLBCL)** or a similar type of lymphoma, as defined by the 2016 World Health Organization classification. This includes patients whose DLBCL has changed from a slower-growing type of lymphoma.
  • Must have a disease that has come back after treatment or did not respond to at least one previous treatment that involved multiple drugs.
  • Must not be considered suitable for **stem cell transplantation** due to factors like overall health, age, or other significant health issues.
  • Must have a disease that can be measured using specific imaging tests like **PET-CT**, **CT**, or **MRI** scans.
  • Must have available tumor tissue samples for testing. If multiple samples are available, the most recent one is preferred.
  • Must have an **ECOG performance status** of 0-2, which is a scale used to assess how a patient's disease is affecting their daily living abilities.
  • Must have adequate organ function based on specific laboratory test results, including:
    • A certain level of **neutrophils** (a type of white blood cell) without recent use of growth factors.
    • A certain level of **platelets** (cells that help with blood clotting) without recent transfusions.
    • Levels of liver enzymes (**ALT**, **AST**, **GGT**) within a specific range.
    • **Total bilirubin** within a specific range, with some exceptions for patients with known **Gilbert's syndrome**.
    • **Creatinine clearance** (a measure of kidney function) at a certain level, calculated using a specific formula.
    • Women who can have children must have a negative pregnancy test within 7 days before starting the study drug.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions or factors that the study team believes would make it unsafe or inappropriate for them to participate cannot participate.
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Investigated drugs

  • Loncastuximab Tesirine

    is a medication being studied for its effectiveness in treating patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL) that has returned or not responded to previous treatments. It works by targeting and delivering a toxic substance directly to the cancer cells, which may help to kill them.

  • Rituximab

    is a medication used in combination with other treatments to help manage certain types of cancer, including DLBCL. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

What is already known about the treatment

  • Loncastuximab Tesirine

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Diffuse Large B-Cell Lymphoma (DLBCL). It is not yet widely used in standard medical practice but shows promise in medical literature as a potential treatment option. The main therapeutic indication is for patients with relapsed or refractory DLBCL. At the molecular level, loncastuximab tesirine works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic payload that helps to kill these cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic agent.

  • Rituximab

    This medication is also administered intravenously and is well-established in medical practice for treating various types of lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL). It is widely recognized in medical literature and is used in combination with other therapies for its therapeutic benefits. Rituximab is primarily indicated for patients with certain types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Its mechanism of action involves targeting the CD20 protein on the surface of B-cells, leading to their destruction. Rituximab is classified as a monoclonal antibody, specifically designed to target and eliminate cancerous B-cells.

Investigated diseases

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, or other organs. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can progress quickly, requiring prompt medical attention. It is the most common subtype of non-Hodgkin lymphoma and can occur at any age, though it is more frequently diagnosed in older adults. The progression of the disease can vary, with some cases responding well to treatment while others may be more challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503916-33-00Protocol codeADCT-402-311Estimated enrolment418 patientsSponsorADC Therapeutics SA

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