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Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma

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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 the effectiveness of a treatment for , a type of cancer that affects the white blood cells. The study involves a combination of medications, including , , and a reduced dose of a chemotherapy regimen known as R-miniCHOP. R-miniCHOP includes several drugs: , , , , and . The purpose of the study is to determine if adding acalabrutinib to the R-miniCHOP treatment can help patients live longer without the disease getting worse, compared to using R-miniCHOP alone.

Participants in the study will receive either the combination of acalabrutinib with R-miniCHOP or R-miniCHOP alone. The study is designed for older adults who have not been treated for DLBCL before. The treatment will be administered over a period of time, with regular check-ups to monitor the patient's health and the progression of the disease. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study aims to provide valuable information on whether the addition of acalabrutinib can improve outcomes for patients with DLBCL. The results will help doctors understand if this combination of treatments is more effective than the standard R-miniCHOP therapy. This research is important for developing better treatment options for patients with this type of lymphoma.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of acalabrutinib with R-miniCHOP, and the other group will receive R-miniCHOP alone. This is to compare the effectiveness of the treatments.

  2. Step 2

    Treatment phase

    During the treatment phase, you will receive a combination of medications. These include doxorubicin, prednisone, cyclophosphamide, acalabrutinib, rituximab, vincristine sulfate, prednisolone, and pegfilgrastim. The medications will be administered either orally or through an intravenous (IV) line, depending on the specific drug.

    The treatment is given in cycles. Each cycle lasts for a specific period, and the exact duration and frequency of each medication will be explained to you by the medical team. It is important to follow the schedule provided to ensure the best possible outcome.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes physical examinations, blood tests, and imaging studies. These assessments help in understanding how the treatment is affecting your condition and in making any necessary adjustments.

  4. Step 4

    End of treatment

    At the end of the treatment phase, a final set of assessments will be conducted to determine the overall response to the therapy. This will include evaluating the progression of the disease and any side effects experienced during the trial.

  5. Step 5

    Follow-up

    After completing the treatment, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment. These visits are crucial for ensuring your well-being and for gathering data on the long-term effectiveness of the treatment.

Who can join the trial?

13 criteria

  • Ability to understand the purpose and risks of the study and capable of giving signed informed consent.
  • Meet specific laboratory test results:
    • Absolute neutrophil count (ANC) of at least 1500 cells/µl or platelet count of at least 100,000/µl, unless the lymphoma is causing lower counts.
    • Serum AST and ALT levels no more than 3 times the upper limit of normal, unless the lymphoma is causing higher levels.
    • Total bilirubin no more than 1.5 times the upper limit of normal, unless due to Gilbert’s syndrome or lymphoma.
    • Estimated creatinine clearance of at least 30 mL/min, or serum creatinine no more than 2.5 times the upper limit of normal.
    • Provide signed and dated written consent before any study-specific procedures.
    • Willing and able to participate in all required evaluations and procedures, including swallowing capsules and tablets without difficulty.
    • Men and women over 80 years old, or over 60 up to 80 years old and not eligible for full-dose R-CHOP treatment.
    • Sexually active male patients must agree to use highly effective contraception with a condom during the study.
    • Sexually active female patients must agree to use highly effective contraception during the study.
    • Have a confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL) or related types, as specified in the study.
    • Disease stage I with a large tumor (at least 7.5 cm), or stage II, III, or IV according to the Ann Arbor Classification.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. A score of 3 is acceptable only if it is directly due to lymphoma.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer that is not one of the specific types of **large B-cell lymphoma** listed in the study.
  • Patients who have already received treatment for **diffuse large B-cell lymphoma (DLBCL)**.
  • Patients who are younger than 60 years old and are eligible for full-dose R-CHOP treatment.
  • Patients who are unable to take the study medication due to allergies or other medical reasons.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe heart problems or uncontrolled medical conditions.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of other serious diseases that might interfere with the study.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Acalabrutinib

    is a medication that works by blocking a specific protein in the body that helps cancer cells grow. It is used in this trial to see if it can help stop the progression of a type of cancer called diffuse large B-cell lymphoma when used together with other cancer treatments.

  • Rituximab

    is a medication that targets and attaches to a specific protein found on the surface of certain cancer cells. By doing this, it helps the body's immune system to destroy these cancer cells. In this trial, it is used as part of a combination treatment to help fight the cancer more effectively.

  • CHOP

    is a combination of four different chemotherapy drugs that work together to kill cancer cells. Each drug in the CHOP regimen attacks the cancer cells in a different way, making it harder for the cancer to survive and grow. In this trial, a reduced dose of CHOP, called R-miniCHOP, is used to treat older adults with a specific type of lymphoma.

What is already known about the treatment

Acalabrutinib – Acalabrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating certain types of lymphoma, particularly in older adults with untreated diffuse large B-cell lymphoma (DLBCL). The main therapeutic indication for acalabrutinib in this trial is to potentially improve progression-free survival when combined with other medications. At the molecular level, acalabrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancer cells. It is classified as a Bruton's tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

  • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)

    This is a type of non-Hodgkin lymphoma characterized by large B-cells that grow rapidly. It typically starts in lymph nodes but can also affect other organs. The disease progresses quickly, with symptoms such as swollen lymph nodes, fever, and weight loss. It can spread to other parts of the body, including the bone marrow and central nervous system.

  • Primary cutaneous diffuse large B-cell lymphoma, leg type

    This lymphoma primarily affects the skin, particularly on the legs. It presents as rapidly growing tumors or nodules on the skin. The disease progresses with the potential to spread to other areas of the skin and sometimes to internal organs. It is characterized by large B-cells in the skin tissue.

  • Intravascular large B-cell lymphoma

    This rare lymphoma involves the growth of large B-cells within the blood vessels. It often affects the skin and central nervous system, leading to symptoms like skin lesions and neurological issues. The disease progresses as these cells obstruct blood flow, causing organ dysfunction. It can be challenging to diagnose due to its non-specific symptoms.

  • Epstein-Barr virus-positive diffuse large B-cell lymphoma not otherwise specified (EBV+ DLBCL NOS)

    This lymphoma is associated with the Epstein-Barr virus and involves large B-cells. It typically affects older adults and can present with symptoms like swollen lymph nodes and fever. The disease progresses with the potential to involve multiple organs. It is characterized by the presence of EBV in the tumor cells.

  • Human herpesvirus 8-positive diffuse large B-cell lymphoma not otherwise specified (HHV8+ DLBCL NOS)

    This lymphoma is linked to human herpesvirus 8 and involves large B-cells. It often occurs in individuals with compromised immune systems. The disease progresses with symptoms such as lymph node enlargement and systemic involvement. It is characterized by the presence of HHV8 in the tumor cells.

  • Primary mediastinal (thymic) large B-cell lymphoma

    This type of lymphoma originates in the thymus, located in the mediastinum. It presents with symptoms like chest pain, cough, and breathing difficulties. The disease progresses as the tumor grows and may spread to nearby structures. It is characterized by large B-cells in the thymic tissue.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501187-18-00Protocol codeARCHED/GLA 2022-1Estimated enrolment360 patientsSponsorUniversitaet Des Saarlandes

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