A trial looking at high dose chemotherapy, radiotherapy and stem cell transplant for people with primary lymphoma of the brain or spinal cord (IELSG32)
Cancer type:
Status:
Phase:
This trial looked at improving treatment for people with recently diagnosed primary lymphoma of the brain or spinal cord. This is a type of non-Hodgkin lymphoma called central nervous system (CNS) lymphoma.
Cancer Research UK supported this trial.
More about this trial
Chemotherapy followed by radiotherapy to the whole brain is the usual treatment for CNS lymphoma. Methotrexate and cytarabine are 2 drugs often used. But doctors are always looking at new ways to improve treatment.
We knew from research that thiotepa and rituximab might also help people with lymphoma.
Thiotepa is a chemotherapy drug. Rituximab is a biological therapy called a monoclonal antibody.
Researchers wanted to see if adding these 2 drugs to methotrexate and cytarabine would improve treatment. So they compared 3 different combinations:
- methotrexate and cytarabine
- methotrexate, cytarabine and rituximab
- methotrexate, cytarabine, thiotepa and rituximab
After chemotherapy people with CNS lymphoma usually have radiotherapy to the whole brain. The researchers thought that chemotherapy followed by a stem cell transplant might be better than radiotherapy.
The aims of this trial were to find out:
- which combination of chemotherapy drugs is better to treat CNS lymphoma and what the side effects of these combinations are
- whether it was best to have whole brain radiotherapy or a stem cell transplant
Summary of results
The trial team found the addition of thiotepa and rituximab to methotrexate and cytarabine worked well for people up to the age of 70 with CNS lymphoma.
This was a phase 2 trial. It was a randomised trial. The people taking part were put into treatment groups by a computer. Neither they nor their doctor could choose which group they were in.
Everyone had chemotherapy to start. After their chemotherapy they were randomised again to have further treatment as part of the trial.
227 people took part and the team were able to look at the results of 219.
- 75 people had methotrexate and cytarabine
- 69 people had methotrexate, cytarabine and rituximab
- 75 people had methotrexate, cytarabine, thiotepa and rituximab
At the end of treatment the researchers looked at the number of people who had no sign of lymphoma (
) and those who lymphoma had shrunk ().
They found of those who had a complete response:
- 17 people had methotrexate and cytarabine
- 21 people had methotrexate, cytarabine and rituximab
- 37 people had methotrexate, cytarabine, rituximab and thiotepa
For those who had a partial response:
- 23 people had methotrexate and cytarabine
- 30 people had methotrexate, cytarabine and rituximab
- 28 people had methotrexate, cytarabine, rituximab and thiotepa
The most severe side effects in all 3 groups were:
- a drop in blood cells
- high temperature (fever) and low white blood cells (febrile neutropenia)
- infection
Based on these results the trial team concluded the combination of methotrexate, cytarabine, rituximab and thiotepa should be . This is for people
- younger than 70 years old
- newly diagnosed with CNS lymphoma
They also think this combination of drugs should be used as the in future randomised trials for CNS lymphoma.
The trial team are continuing to follow up the people who after this had:
- whole brain radiotherapy
- a stem cell transplant
When these results become available we will update this summary.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Kate Cwynarski
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
International Extranodal Lymphoma Study Group (IELSG)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
Southampton Clinical Trials Unit
Other information
This is Cancer Research UK trial number CRUK/10/023.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
