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Study on Preventing Heart Problems in Patients with Diffuse Large B-Cell Lymphoma Using Dexrazoxane and a Drug Combination

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 the prevention of heart problems caused by certain cancer treatments in patients with Diffuse Large B-Cell Lymphoma (DLBCL). The study will use a medication called Dexrazoxane, which is being tested to see if it can protect the heart from damage caused by a group of cancer drugs known as anthracyclines. These drugs are commonly used in a treatment regimen called R-CHOP21, which includes several medications: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone. In some cases, Lenalidomide may also be included in the treatment plan.

The purpose of the study is to determine if Dexrazoxane can effectively prevent heart damage in patients receiving these treatments. Participants will be randomly assigned to receive either Dexrazoxane or a placebo, in addition to their standard cancer treatment. The study will monitor the participants' heart health and overall response to the cancer treatment over a period of time. This will include regular check-ups and tests to assess heart function and the effectiveness of the cancer treatment.

The study will last for a period of approximately 126 days, with follow-up assessments to evaluate the long-term effects on heart health and cancer progression. The goal is to improve the safety and effectiveness of cancer treatments for patients with Diffuse Large B-Cell Lymphoma by reducing the risk of heart-related side effects. Participants will be closely monitored throughout the study to ensure their safety and well-being.

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, a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) is required.

    Eligibility includes being 18 years or older and having a performance status that allows participation.

    A negative pregnancy test is necessary for women of childbearing potential.

  2. Step 2

    Treatment initiation

    The treatment plan involves six cycles of R-CHOP21, which includes the following medications:

    Rituximab administered intravenously.

    Cyclophosphamide administered intravenously.

    Doxorubicin hydrochloride administered intravenously.

    Vincristine sulfate administered intravenously.

    Prednisolone taken orally.

  3. Step 3

    Additional medications

    In some cases, additional medications may be included:

    Lenalidomide taken orally for specific lymphoma types.

    Dexrazoxane administered intravenously to prevent heart-related side effects.

    Pegfilgrastim as an injectable solution to support blood cell counts.

  4. Step 4

    Monitoring and assessments

    Regular monitoring of heart function and overall health is conducted throughout the treatment.

    Assessments include imaging tests and blood tests to evaluate treatment response and side effects.

  5. Step 5

    Completion of treatment

    After completing the six cycles of R-CHOP21, additional assessments are performed to determine the treatment's effectiveness.

    Follow-up includes monitoring for any long-term effects or recurrence of the disease.

Who can join the trial?

10 criteria

  • Patients must have **untreated** diffuse large B-cell lymphoma (DLBCL), which is a type of cancer affecting the lymphatic system. This includes specific subtypes like high-grade B-cell lymphoma and follicular lymphoma.
  • Patients must provide **written informed consent**, which means they agree to participate after understanding the study details.
  • Patients should have a **planned treatment** with a specific chemotherapy regimen called R-CHOP21, or similar approved treatments.
  • Patients should be in **Ann Arbor stages II-IV** of the disease, or stage I if they have a large tumor (bulky disease).
  • Patients must be **18 years or older**.
  • Patients should have a **WHO performance status** of 2 or less, which measures their ability to perform daily activities. A status of 3 is allowed if it's directly related to DLBCL.
  • Women of childbearing potential must have a **negative pregnancy test** at the start of the study.
  • Female patients must be either **post-menopausal**, surgically sterile, or agree to use two effective methods of contraception or abstain from heterosexual intercourse during and after the study.
  • Male patients must agree to use **effective barrier contraception** or abstain from heterosexual intercourse during and after the study.
  • Patients must be able to **follow the study schedule** and meet other study requirements.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than Diffuse large B-cell lymphoma (DLBCL).
  • Patients who are not receiving the specific treatment called R-CHOP21.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication.
  • Patients who have a history of heart problems that could be worsened by the study treatment.
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Investigated drugs

  • Dexrazoxane

    is a medication used in this trial to prevent heart damage that can be caused by certain cancer treatments. It is given to patients with diffuse large B-cell lymphoma to protect their heart while they receive chemotherapy.

  • R-CHOP21

    is a combination of cancer-fighting drugs used to treat diffuse large B-cell lymphoma. It includes several medications that work together to kill cancer cells and stop them from growing. This combination is part of the standard treatment for this type of lymphoma.

What is already known about the treatment

Dexrazoxane – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in preventing heart damage caused by certain cancer treatments. It is primarily used in patients with diffuse large B-cell lymphoma (DLBCL) who are undergoing chemotherapy. Dexrazoxane works by protecting heart cells from the harmful effects of anthracyclines, a type of chemotherapy drug, by inhibiting an enzyme that leads to the formation of free radicals. It is classified as a cardioprotective agent and is being evaluated for its ability to reduce cardiac dysfunction while maintaining the effectiveness of cancer treatment.

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. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, requiring prompt medical attention. It is the most common type of non-Hodgkin lymphoma in adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505377-32-00Estimated enrolment324 patientsSponsorHemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

sourced from the EU Clinical Trials Register and site verification

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