HOVON 127 BL / SAKK 37/16: Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma
Burkitt lymphoma is a rare, fast-growing type of blood cancer. While intensive chemotherapy can often cure it, the treatments can be very hard on the body and often require long hospital stays. This Phase III clinical trial compares two different combinations of cancer medicines: a regimen called R-CODOX-M/R-IVAC and another called dose-adjusted EPOCH-R. Both combinations use several chemotherapy drugs alongside an antibody treatment called rituximab. The main goal is to find out which of these two approaches is better at keeping the cancer from coming back over two years. Doctors also want to learn which treatment causes fewer severe side effects and allows patients to spend less time staying in the hospital. The study is open to adults aged 18 and over who have newly diagnosed, high-risk Burkitt lymphoma.
At a glance
What is this study about?
Burkitt lymphoma is a rare type of non-Hodgkin lymphoma. It affects white blood cells and can grow and spread very quickly. Because of how fast it develops, doctors must start treatment promptly with strong combinations of cancer-fighting drugs.
Currently, different hospitals may use different drug recipes to treat this cancer. One common standard treatment is known as R-CODOX-M/R-IVAC. Another approach is called dose-adjusted EPOCH-R (DA-EPOCH-R), which adjusts drug doses based on regular blood test results. Both regimens have cured many patients, but doctors do not yet know for sure which one offers the best balance of clearing the cancer and keeping side effects manageable.
This Phase III study compares both treatments side-by-side in a large group of patients. By tracking patients over at least two years, researchers hope to see which treatment gives the best chance of long-term recovery and whether one allows people to spend fewer days admitted to a hospital ward.
Key takeaways
- Compares two standard, intensive chemotherapy regimens for high-risk Burkitt lymphoma.
- Aims to discover which treatment keeps cancer away longer with fewer hospital stays.
- Open to adults aged 18 and older with newly diagnosed disease.
- Every participant receives active cancer therapy; no dummy treatments are used.
- Participants are monitored closely during treatment and followed up for at least two years.
Who may be eligible?
This trial is for adults aged 18 and older who have recently been diagnosed with high-risk Burkitt lymphoma. To take part, you must have high-risk disease (which your specialist determines based on tests such as your scan results and blood levels) and you must not have already received full chemotherapy for it.
You may not be able to take part if you have other severe medical conditions—such as serious heart, kidney, or liver disease—that would make intensive chemotherapy unsafe. Your medical team will also check that you are well enough to cope with strong cancer medications before you join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are 18 years of age or older.
- You have a confirmed new diagnosis of Burkitt lymphoma.
- Your medical team has classified your lymphoma as high-risk.
- You have not yet started standard chemotherapy for this diagnosis.
- You are generally well enough to undergo intensive cancer therapy.
What does participation involve?
If you take part, a computer will randomly place you into one of two treatment groups. You have an equal chance of being in either group, and neither you nor your doctor can choose. Both groups receive intensive cancer treatment through a vein (intravenous drip) and as tablets.
Depending on which group you are in, you may need to stay overnight in hospital for parts of your treatment, or receive some drugs in an outpatient clinic. You will have regular blood tests, physical checks, and imaging scans (such as CT or PET scans) to see how the cancer responds. Once your treatment finishes, your care team will continue to see you for regular check-ups for at least two years to monitor your health and recovery.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedNetherlands
Common questions
Will I receive a placebo (dummy drug) in this trial?
No. Everyone in this trial receives active, intensive cancer treatment. Placebos are not used because Burkitt lymphoma requires immediate, strong therapy.
How is it decided which treatment I get?
A computer programme assigns you to one of the two treatment groups by chance. This process is called randomisation, and it ensures the comparison is fair.
How long does the treatment take?
The active chemotherapy usually takes several months to complete, followed by at least two years of regular monitoring visits.
Can I leave the study if I change my mind?
Yes. You can step down from the study at any point. Your doctors will continue to give you the best available standard care.
Do I have to pay anything to take part?
No. Trial treatments and standard hospital care are provided through the NHS at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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