A trial looking at high dose chemotherapy, radiotherapy and stem cell transplant for people with primary lymphoma of the brain or spinal cord (IELSG32)

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 (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 

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 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.