A trial looking at a different way of giving a drug combination called MATRix for people with primary lymphoma of the brain and spinal cord (OptiMATe)
Cancer type:
Status:
Phase:
This trial is looking at a different way of giving a combination of drugs called MATRix. It is for people with primary lymphoma of the brain and spinal cord. This is also called primary CNS lymphoma.
This trial is open to people who are newly diagnosed with 
CNS lymphoma:
- that is a large Diffuse B cell lymphoma
- and are due to have MATRix followed by an autologous stem cell transplant
More about this trial
Doctors can treat primary CNS lymphoma (PCNSL) with a combination of and . If this works well, it is followed by and a stem cell transplant of your own stem cells. This is called an .
MATRix is a drug combination that doctors use as the first treatment before high dose chemotherapy and an autologous stem cell transplant. It has 3 chemotherapy drugs:
- methotrexate (M)
- cytarabine also called AraC (A)
- thiotepa (T)
And you also have a called rituximab (Rix).
You have . The standard number of treatment cycles for MATRix is 4. Unfortunately, the side effects can be quite bad. These side effects can delay or possibly stop the planned stem cell transplant.
In this trial, researchers are looking at giving:
- fewer drugs in the first cycle of treatment
- fewer cycles of MATRix before having a stem cell transplant
The aims of the trial are to find out whether having fewer cycles of MATRix:
- is better at treating the cancer than the standard number of cycles followed by an autologous stem cell transplant
- allows more people to have an autologous stem cell transplant
- is safer and the side effects are less severe, particularly those affecting the brain
- reduces how long patients are in hospital due to side effects
- improves the
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- are newly diagnosed with a primary tumour of the brain and spinal cord that is a diffuse large B cell lymphoma
- have an
immune system that is working well - have at least one area of cancer that the doctor can measure
- have kidneys that work well enough. Your doctor will do a test for this.
- have satisfactory blood test results
- are willing to use 2 reliable forms of contraception during the trial if you or your partner could become pregnant
- are able to give
informed consent , or have a family member willing to do so on your behalf if you are not able to - are between 18 and 70 years old
Please note if you are between 66 and 70 years old you must be up and about for more than half the day, be able to look after yourself but might not be able to work (performance status 0, 1 or 2)
Who can’t take part
You cannot join this trial if any of these apply. You:
- have already had treatment for lymphoma. This is apart from surgery and taking steroids.
- have lymphoma that is in other parts of the body as well as the brain and spinal cord
- have lymphoma that is only in the eye
- have lymphoma that is only in the tissue surrounding the brain and spinal cord
- have had a non-Hodgkin lymphoma before
- have, or had another cancer. This is apart from successfully treated
non melanoma skin cancer , carcinoma in situ of the of cervix , early prostate cancer that does not need treatment, hormone receptor positive breast cancer that has been treated with surgery and chemotherapy and has not spread. Or any other cancer that was treated with the aim to cure and there has not been any sign of it in the past 2 years. - have an
immune system that does not work well - have HIV, active hepatitis B, active hepatitis C or you have any active infection
- have had an
organ transplant - have taken an experimental drug as part of another clinical trial within the past 30 days before joining the trial
- have extra fluid within the body tissue or in a space in the body that might affect you taking part
- are taking medication that might interfere with the treatment in this trial. Your doctor will know about this.
- are allergic or sensitive to any of the treatments in this trial or any of their ingredients
- have a
heart problem , lung problems or liver problems that could affect you taking part in the trial. Your doctor will know about this. - have a problem with the overuse of alcohol, drugs or medication
- are, or planning to become, pregnant or you are breastfeeding
- have any other medical condition, mental health problem or other circumstances that could affect you taking part in the trial
Trial design
This is a European phase 3 trial. The team need 326 people to take part, including 80 people from the UK.
This is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you go into. The 2 groups are:
- standard MATRix followed by high dose chemotherapy and an autologous stem cell transplant
- reduced MATRix followed by high dose chemotherapy and an autologous stem cell transplant
Standard MATRix followed by high dose chemotherapy and an autologous stem cell transplant
MATRix is a drug combination of:
- methotrexate
- cytarabine
- thiotepa
- rituximab
You have all these drugs as a drip into a vein. You have . Each treatment cycle is 3 weeks long. You have 4 cycles of treatment.
In the first week of each cycle, you have:
- rituximab on day 1 and day 5
- methotrexate on day 2
- cytarabine over day 3 and 4
- thiotepa on day 5
You have high dose chemotherapy before your stem cell transplant. This is standard treatment. Your doctor will tell you about this and the transplant.
Reduced MATRix followed by high dose chemotherapy and an autologous stem cell transplant
You have the same drugs. You have all these as a drip into a vein.
You have 3 cycles of treatment.
For the first cycle, you have:
- rituximab on day 1
- methotrexate on day 2
After 10 to 14 days, you then have 2 cycles of MATRix as described in the standard MATRix group.
You have high dose chemotherapy before your stem cell transplant. This is standard treatment. Your doctor will tell you about this and the transplant.
Quality of life
You fill in questionnaires when you join the trial and then:
- at the end of treatment
- at regular times during the follow up
The questions ask about:
- your general health and wellbeing
- your daily activities
- any side effects
These are quality of life questionnaires.
Samples for research
The trial team will take blood samples. Where possible they will take the samples when you have blood taken as part of your routine care.
As part of your routine care you will have a . This is to take a sample of the fluid that surrounds your brain and spinal cord (CSF). When you have a lumbar puncture as part of your routine care, the trial team will ask for some of the CSF.
They will ask for a piece of the sample of tissue () taken when you were diagnosed.
The team will use these samples to:
- learn more about primary brain and spinal cord lymphoma
- look for substances (
biomarkers ) that might tell doctors how well treatment is working
The team will ask if they can store these samples for future researchers to use. You do not have to agree to have the samples stored for future research.
Scans for research
As part of your routine care, you have of your brain. These will be used to monitor your cancer during the trial.
The team will ask for a scan:
- when you join the trial
- during the trial treatment
- after your stem cell transplant
- routinely during the trial follow-up
Sub study
Some hospitals are also doing an imaging .
You do not have any extra MRI scans as part of the sub study. But the scans will be about 30 minutes longer. It will take about 90 minutes instead of 60 minutes.
You do not have to agree to this sub study if you do not want to. You can still take part in the trial.
Hospital visits
You see the doctor for a and tests before taking part. These tests include:
- blood tests
- a heart trace (ECG)
- a heart scan (ECHO)
- an MRI scan
- a CT scan or a PET-CT scan
- an ultrasound
- a lumbar puncture
- a test to see how well your brain works by looking at your reading, use of language, memory, concentration and similar things
- quality of life questionnaires
You see the doctor during treatment for blood tests and to see how you are.
You see the doctor at the end of your treatment. This will be after your stem cell transplant or before if you do not have a transplant. You have the same tests you had at the start.
Follow up
You see the doctor:
- every 3 months up to 2 years
- every 6 months from year 3 to year 5
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of methotrexate include:
- loss of appetite
- indigestion
- feeling or being sick
- tummy (abdominal) pain
- sore mouth
- changes to how your liver works
The most common side effects of cytarabine include:
- a drop in the number of red blood cells causing tiredness and breathlessness
- loss of appetite
- eye inflammation (conjunctivitis)
- difficulty swallowing
- tummy (abdominal) pain
- feeling or being sick
- diarrhoea
- changes to how your liver works
- skin rash
- fever
The most common side effects of thiotepa include:
- a drop in white blood cells causing an increased risk of infection
- dizziness
- headaches
- blurred sight
- hearing changes
- eye inflammation (conjunctivitis)
- abnormal heartbeat
- high blood pressure
- feeling or being sick
- diarrhoea
- inflammation of the bowel (colitis)
- skin rash
- hair loss
- muscle and joint pain
- fever
- chills
The most common side effects of rituximab include:
- fevers
- chills
- flu-like symptoms
These mainly happen when you have the first dose. You can take paracetamol or anti histamines to manage them.
We have more information about:
- methotrexate and its side effects
- cytarabine and its side effects
- thiotepa and its side effects
- rituximab and its side effects
- having an autologous stem cell transplant
Your doctor will talk to you about the possible side effects of all the treatments and answer any questions you have before you agree to take part.
Location
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
Professor Christopher Fox
Supported by
Cancer Research UK
Klinikum der Landeshauptstadt Stuttgart gKAöR
Southampton Clinical Trials Unit
Stand Up To Cancer
UKCRC Registered Clinical Trials Units
University of Southampton
Other information
This is Cancer Research UK trial number CRUK/21/011.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
