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Study Comparing Rituximab with Drug Combination for Patients with Newly Diagnosed High-Risk Burkitt 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 treatments for Burkitt lymphoma, a type of cancer that affects the lymphatic system. The study compares two different treatment approaches: one called R-CODOX-M/R-IVAC and another known as DA-EPOCH-R. These treatments involve a combination of medications, including methotrexate, ifosfamide, vincristine, cyclophosphamide, rituximab, etoposide, cytarabine, prednisolone, and doxorubicin. The purpose of the study is to determine which treatment is more effective in improving the progression-free survival of patients, which means the length of time during and after treatment that a patient lives with the disease without it getting worse.

Participants in the study will receive one of the two treatment regimens. The R-CODOX-M/R-IVAC treatment involves a series of medications given through injections or infusions, which are methods of delivering drugs directly into the bloodstream. The DA-EPOCH-R treatment also involves a combination of medications administered in a similar way. Some patients may receive a placebo as part of the study to help compare the effectiveness of the treatments. The study will monitor patients over a period of time to assess their response to the treatment and any side effects they may experience.

The trial aims to confirm whether the DA-EPOCH-R treatment can improve the two-year progression-free survival rate to 85% compared to the expected 70% for the R-CODOX-M/R-IVAC treatment. This means researchers are looking to see if patients can live longer without their disease worsening when treated with DA-EPOCH-R. The study will also look at other outcomes, such as overall survival, which is the time from the start of the study until death from any cause, and the occurrence of any severe side effects. The trial is expected to continue until 2026.

The research process

The trial runs in 6 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 physical examination.

    Eligibility criteria include a first diagnosis of high-risk Burkitt lymphoma, age between 18 and 75 years, and a specific performance status as defined by the World Health Organization (WHO).

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: R-CODOX-M/R-IVAC or DA-EPOCH-R.

    This randomization ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment phase - R-CODOX-M/R-IVAC

    If assigned to the R-CODOX-M/R-IVAC group, the treatment involves a combination of medications administered through various routes.

    Medications include methotrexate (intrathecal use), ifosfamide (intravenous), vincristine (intravenous bolus use), cyclophosphamide (intravenous), rituximab (intravenous infusion), etoposide (intravenous infusion), cytarabine (intrathecal use), prednisolone (oral use), and doxorubicin (intravenous infusion).

    The specific dosage and frequency of each medication are determined by the study protocol.

  4. Step 4

    Treatment phase - DA-EPOCH-R

    If assigned to the DA-EPOCH-R group, the treatment involves a different combination of medications, also administered through various routes.

    The medications and their administration are adjusted based on individual response and tolerance, as per the study protocol.

  5. Step 5

    Monitoring and follow-up

    Throughout the treatment, regular monitoring is conducted to assess the response to therapy and manage any side effects.

    Follow-up visits are scheduled to evaluate the progression-free survival (PFS) and overall survival (OS) at 2 years, as well as other health outcomes.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment phase, an evaluation is performed to determine the overall response rate (ORR) and any adverse effects experienced during the study.

    The number of hospitalization days and any significant toxicities are also recorded.

Who can join the trial?

5 criteria

  • The patient must have a first diagnosis of **high risk Burkitt lymphoma**. This includes both sporadic cases and those associated with **HIV**. The diagnosis should be confirmed by examining tissue samples according to the **World Health Organization (WHO)** classification from 2008 or 2016.
  • The patient must have **high risk disease**, which means they have at least one of the following: high levels of **LDH** (a substance in the blood that can indicate tissue damage), a **WHO performance status** of 2 or higher (a measure of how the disease affects daily living), **Ann Arbor stage III or IV** (a way to describe how much the lymphoma has spread), or a tumor mass that is 10 cm or larger.
  • The patient must be between the ages of 18 and 75 years old.
  • The patient must have a **WHO performance status** between 0 and 3. If the status is 4, it must be due to the disease itself.
  • The patient must provide **written informed consent**, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

9 criteria

  • Patients who do not have a diagnosis of Burkitt lymphoma cannot participate. Burkitt lymphoma is a type of cancer that affects the lymphatic system.
  • Patients who are not considered high risk for Burkitt lymphoma are excluded. High risk means the disease is more likely to progress or come back.
  • Patients who are outside the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are not able to follow the study procedures or attend the required visits are excluded.
  • Patients who have other medical conditions that might interfere with the study treatment or outcomes are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may be excluded.
  • Patients who have allergies or reactions to the study medications are excluded.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, are excluded.
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Investigated drugs

  • R-CODOX-M

    is a combination chemotherapy regimen used to treat high-risk Burkitt lymphoma. It includes several medications that work together to kill cancer cells and stop them from growing. This regimen is typically used in patients who have been newly diagnosed with this type of lymphoma.

  • R-IVAC

    is another chemotherapy regimen used in the treatment of high-risk Burkitt lymphoma. Like R-CODOX-M, it combines different medications to target and destroy cancer cells. This regimen is part of the treatment plan for patients with newly diagnosed cases.

  • DA-EPOCH-R

    is a chemotherapy regimen that adjusts the dose of its medications based on the patient's response. It is used to treat high-risk Burkitt lymphoma and aims to improve progression-free survival rates. This regimen includes a combination of drugs that work together to attack cancer cells.

What is already known about the treatment

  • R-CODOX-M/R-IVAC

    This medication is administered intravenously and is used in the treatment of high-risk Burkitt lymphoma. It is currently being studied in clinical trials to compare its effectiveness with another treatment regimen. The main therapeutic indication is for patients with newly diagnosed high-risk Burkitt lymphoma. The mechanism of action involves targeting and destroying rapidly dividing cancer cells. It is classified as a chemotherapy regimen.

  • DA-EPOCH-R

    This medication is also administered intravenously and is used for treating high-risk Burkitt lymphoma. It is under investigation in clinical trials to determine its efficacy compared to other treatment options. The primary therapeutic indication is for patients with newly diagnosed high-risk Burkitt lymphoma. Its mechanism of action includes inhibiting cancer cell growth by interfering with DNA replication. It is classified as a chemotherapy regimen.

Investigated diseases

Burkitt lymphoma – Burkitt lymphoma is a type of non-Hodgkin lymphoma that originates from B cells, a type of white blood cell. It is characterized by the rapid growth of tumors, often in the abdomen, but it can also affect other parts of the body such as the jaw, central nervous system, and other organs. This disease is known for its aggressive nature, meaning it progresses quickly if not managed. It is more common in children and young adults, and it is associated with certain infections, such as the Epstein-Barr virus. The disease is considered rare, and its rapid progression requires prompt medical attention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503423-25-00Protocol codeHOVON 127 BLEstimated enrolment89 patientsSponsorHaemato Oncology Foundation For Adults Netherlands

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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).