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Study of Acalabrutinib and Tafasitamab for Patients with Previously Treated Marginal Zone 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 a type of cancer called Marginal Zone Lymphoma (MZL), which is a form of lymphoma that affects certain white blood cells. The study is specifically for patients whose MZL has returned or has not responded to previous treatments. The trial will test the effectiveness of two medications used together: acalabrutinib and tafasitamab. Acalabrutinib is taken as a hard capsule, while tafasitamab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to determine how well these two medications work together in treating patients with relapsed or refractory MZL. Participants in the study will receive both medications over a period of up to 24 months. The study will monitor how the cancer responds to the treatment and will also keep track of any side effects experienced by the participants. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, participants will have regular check-ups to assess their health and the progress of their treatment. The study aims to provide valuable information on whether the combination of acalabrutinib and tafasitamab can be an effective treatment option for patients with MZL who have limited options due to the return or resistance of their disease. This research could potentially lead to new treatment strategies for managing 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include adequate kidney and liver function, and a confirmed diagnosis of marginal zone lymphoma (MZL) that is either relapsed or refractory.

  2. Step 2

    Treatment initiation

    The treatment involves two medications: tafasitamab and acalabrutinib.

    Tafasitamab is administered as a solution for infusion through a vein (intravenous use).

    Acalabrutinib is taken orally in the form of hard capsules.

  3. Step 3

    Treatment schedule

    The specific dosage and frequency of administration for each medication are determined by the study protocol and the healthcare team.

    The treatment continues for a duration specified by the study, with regular monitoring to assess response and manage any side effects.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular evaluations are conducted to monitor the response to treatment.

    These evaluations include assessing the complete response rate and overall response rate, as well as monitoring for any adverse events.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up assessments are conducted to evaluate the duration of response and overall survival.

    The follow-up period extends for a specified time after the last dose of the investigational medications.

Who can join the trial?

16 criteria

  • Ability to understand and willingness to sign a written informed consent.
  • Have good kidney and liver function.
  • Have normal blood clotting ability.
  • Women who can have children must use highly effective birth control, not be pregnant or breastfeeding, and agree not to become pregnant during the trial and for at least 3 months after the last dose of the trial medication.
  • Men must agree not to father a child during the trial and for at least 3 months after the last dose of the trial medication.
  • Be able and willing to swallow trial drugs as whole capsules.
  • Have a confirmed diagnosis of **Marginal Zone Lymphoma (MZL)**, which is a type of cancer.
  • The disease must not respond to previous treatments or must have returned after treatment.
  • Need treatment for the disease, which includes certain symptoms or conditions like:
    • **EMZL**: Symptoms or other reasons for treatment, such as disease getting worse, large tumors, risk of organ damage, or personal choice, and failure of previous treatments.
    • **SMZL**: Growing or painful spleen and/or worsening blood cell counts.
    • **NMZL**: Symptoms like fever, weight loss, or night sweats, worsening blood counts due to cancer in the bone marrow, or large lymph nodes pressing on important organs.
    • Have lesions (areas of disease) that can be measured or evaluated, even if not visible on scans, like in the stomach or bone marrow.
    • Be in **Ann Arbor Stage I-IV**, which describes the extent of the disease.
    • Have an **ECOG performance status** of 0, 1, or 2, meaning the patient is fully active or has some limitations but can still care for themselves, with no worsening in the last 2 weeks.
    • Be 18 years of age or older.
    • Have a certain level of white blood cells (**absolute neutrophil count**) and platelets, unless low levels are due to cancer in the bone marrow or an enlarged spleen.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Marginal Zone Lymphomas that are difficult to treat or have returned after previous treatment cannot participate. Marginal Zone Lymphomas are a type of cancer that affects certain white blood cells.
  • Patients who have not experienced a return of their lymphoma after previous treatment are not eligible.
  • Patients who have not received prior systemic therapy, which means treatment that affects the entire body, are excluded.
  • 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 are not eligible.
  • Patients who are not considered part of a vulnerable population, which means they may need special protection, are excluded.
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Investigated drugs

  • Acalabrutinib

    is a medication used in this trial to help treat patients with marginal zone lymphomas that have returned or did not respond to previous treatments. It works by blocking certain proteins in cancer cells, which can slow down or stop the growth of the cancer.

  • Tafasitamab

    is another medication used in combination with acalabrutinib in this trial. It is designed to target and attach to specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. This combination aims to improve the treatment outcomes for patients with relapsed or refractory marginal zone lymphomas.

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 marginal zone lymphomas that have not responded to previous treatments or have relapsed. The medication works by inhibiting a specific enzyme called Bruton's tyrosine kinase, which plays a role in the growth and survival of cancer cells. Acalabrutinib is classified as a targeted therapy, specifically a kinase inhibitor.

  • Tafasitamab

    Tafasitamab is given through intravenous infusion. It is under investigation in clinical trials for its potential to treat marginal zone lymphomas that are resistant to or have relapsed after prior systemic therapy. This medication targets a protein called CD19 found on the surface of B-cells, leading to the destruction of these cancerous cells. Tafasitamab is classified as a monoclonal antibody, a type of targeted therapy.

Investigated diseases

Marginal Zone Lymphoma – Marginal Zone Lymphoma (MZL) is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue, which is part of the immune system. It is characterized by the abnormal growth of B-cells, a type of white blood cell, leading to the formation of tumors. MZL can occur in various parts of the body, including the spleen, lymph nodes, and mucosal tissues. The disease often progresses slowly, and symptoms may include swelling of lymph nodes, fatigue, and weight loss. MZL can be classified into different subtypes, such as splenic, nodal, and extranodal, depending on its location. The progression of the disease can vary, with some cases remaining stable for years while others may become more aggressive.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514122-23-00Estimated enrolment24 patientsSponsorAssociation International Extranodal Lymphoma Study Group (IELSG)

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).