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:

Blood cancers
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 2

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 

IELSG32 results diagram

At the end of treatment the researchers looked at the number of people who had no sign of lymphoma (complete response) and those who lymphoma had shrunk (partial response).

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 

IELSG32 results diagram

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

IELSG32 results diagram

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 standard treatment. 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 control group 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 (peer reviewed) 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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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. 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6170

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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