Ongoing Clinical Trials for Burkitt’s Lymphoma
Currently, there are 3 ongoing clinical trials investigating new treatments for Burkitt’s lymphoma. These studies are being conducted across multiple European countries and focus on different treatment approaches, including chemotherapy combinations and innovative cell-based therapies for patients with newly diagnosed or relapsed disease.
Clinical trial locations
- Austria
- Belgium
- France
- Germany
- Italy
- Netherlands
- Spain
- Sweden
Study Comparing Rituximab with Drug Combination for Patients with Newly Diagnosed High-Risk Burkitt Lymphoma
This trial is designed for adults aged 18 to 75 who have been newly diagnosed with high-risk disease. The study compares two different chemotherapy combinations: R-CODOX-M/R-IVAC and DA-EPOCH-R.
Main inclusion criteria:
- First diagnosis of high-risk disease, including cases associated with HIV
- High-risk features such as elevated LDH levels, WHO performance status of 2 or higher, Ann Arbor stage III or IV, or tumors 10 cm or larger
- Age between 18 and 75 years
- WHO performance status between 0 and 3 (or 4 if caused by the disease itself)
- Written informed consent to participate
Main exclusion criteria:
- Absence of confirmed diagnosis
- Not classified as high risk
- Outside the specified age range
- Pregnancy or breastfeeding
- Other medical conditions that might interfere with treatment
- Allergies to study medications
- Recent participation in another clinical trial
- Inability to follow study procedures or provide informed consent
Trial focus: The study aims to determine which treatment regimen better improves progression-free survival, meaning the time patients live without their disease worsening. Researchers hope to confirm whether DA-EPOCH-R can achieve a two-year progression-free survival rate of 85% compared to the expected 70% for R-CODOX-M/R-IVAC. The trial will also assess overall survival and any severe side effects.
Investigational treatments: The study uses two chemotherapy regimens. R-CODOX-M/R-IVAC includes methotrexate, ifosfamide, vincristine, cyclophosphamide, rituximab, etoposide, cytarabine, prednisolone, and doxorubicin. DA-EPOCH-R is a dose-adjusted regimen that combines different medications to target cancer cells, with doses adjusted based on individual patient response.
Study on Brexucabtagene Autoleucel for Adults with Relapsed or Refractory Burkitt Lymphoma
This trial tests a specialized cell therapy called brexucabtagene autoleucel for adults whose disease has returned after treatment or did not respond to previous therapy. This treatment involves modifying a patient’s own immune cells to fight cancer more effectively.
Main inclusion criteria:
- Age 18 years or older
- At least one measurable area of disease based on the Lugano Classification
- Side effects from previous treatments must have improved to mild levels
- ECOG performance status of 0 or 1, meaning patients can be fully active or have some symptoms but can still carry out light work
- Adequate blood and organ function
- Confirmed diagnosis of mature B-cell non-Hodgkin lymphoma
- Disease that has relapsed after complete remission or did not respond to first-line treatment
- Agreement to use contraception if able to have children
Main exclusion criteria:
- A different type of cancer
- Outside the specified age range
- Classified as a vulnerable population
Trial focus: The study evaluates how effective this treatment is in causing the cancer to shrink or disappear, how long these effects last, and the overall survival of participants. The treatment is monitored closely through regular follow-up appointments that include physical examinations and imaging tests.
Investigational treatment: Brexucabtagene autoleucel is a type of CAR T-cell therapy. White blood cells called T-cells are taken from the patient’s body, modified in a laboratory to better recognize and attack cancer cells, and then returned to the patient through an infusion. This therapy helps the immune system target and destroy cancer more effectively.
Study on MB-CART19.1 for Patients with Relapsed or Refractory CD19 Positive B Cell Malignancies
This trial studies a treatment called MB-CART19.1 for patients with various types of B-cell cancers, including the disease in question, that have returned or not responded to previous treatment. The study includes both children and adults.
Main inclusion criteria:
- At least 1 year old and considered fit by their doctor
- Cancer cells must show CD19, a specific marker on their surface
- Sufficient number of CD3+ T cells in the blood
- ECOG performance score of 0-2 for those over 16 years, or Lansky performance score above 50 for younger patients
- No active infections such as Hepatitis B, Hepatitis C, or HIV
- Negative pregnancy test for women who can have children
- Signed consent form from patients and/or parents
Main exclusion criteria:
- Different type of cancer not related to CD19 positive B cell malignancies
- Pregnancy or breastfeeding
- Unable to safely undergo treatment due to other health conditions
- Recent receipt of certain treatments that might interfere
- Active infection or immune system conditions
- History of severe allergic reactions to similar treatments
- Inability to follow study procedures
Trial focus: The study has two phases. The first phase determines the best dose of MB-CART19.1 to use, while the second phase assesses how well the treatment reduces cancer cells. Researchers monitor patients for side effects and improvements throughout the study.
Investigational treatment: MB-CART19.1 is an adoptive cell therapy using modified T-cells. The patient’s own immune cells are collected through a procedure called leukapheresis, then modified in a laboratory to express a receptor that targets CD19 on cancer cells. After the patient receives preparatory chemotherapy, these modified cells are infused back into the bloodstream to help fight the cancer.
Summary
Three clinical trials are currently investigating treatment options for patients with this aggressive form of lymphoma. The trials are distributed across eight European countries, with the Netherlands and Germany hosting multiple studies.
One notable observation is the variety of treatment approaches being tested. For newly diagnosed high-risk patients, researchers are comparing two established chemotherapy regimens to determine which offers better progression-free survival. For patients whose disease has returned or not responded to initial treatment, two different trials are testing innovative cell-based therapies that modify the patient’s own immune cells to fight cancer.
The trials span different patient populations, from newly diagnosed adults to children and adults with relapsed disease. Two of the three studies focus on advanced cell therapy approaches using CAR T-cell technology, reflecting the growing interest in immunotherapy treatments for aggressive lymphomas. The brexucabtagene autoleucel study is being conducted across seven countries, making it the most widely available trial geographically.
Patients interested in participating should discuss eligibility criteria with their healthcare providers, as requirements vary based on disease status, age, and previous treatments received.
