A trial looking at whether obinutuzumab after chemotherapy for CLL can reduce the chances of the leukaemia coming back (GALACTIC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Chronic leukaemia

Leukaemia

Status:

Closed

Phase:

Phase 2/3

This trial is looking at whether having obinutuzumab after chemotherapy reduces the risk of chronic lymphocytic leukaemia (CLL) coming back. The trial is supported by Cancer Research UK.

More about this trial

Doctors often treat CLL with chemotherapy. This can work well and often there is no sign of the leukaemia afterwards (it goes into remission). But very small numbers of leukaemia cells can be left behind, even if the treatment seems to have been successful. Doctors call this minimal residual disease (MRD). We know from research that people with MRD have a higher risk of their leukaemia coming back.

In this trial, researchers are looking at a drug called obinutuzumab for people who have CLL that responded well to chemotherapy.

Obinutuzumab is a type of biological therapy called a monoclonal antibody. Doctors want to see if having this drug after chemotherapy helps people to stay free from CLL for longer.

Who can enter

You may be able to join this trial if all of the following apply.

You have chronic lymphocytic leukaemia (CLL) that has been successfully treated in the last 3 to 24 months
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are willing to use reliable contraception during treatment and for 18 months afterwards if there is any chance that you or your partner could become pregnant
You are at least 18 years old

You cannot join this trial if any of these apply. You

Have already had more than 3 different treatments for CLL
Have had a stem cell transplant using cells from a donor
Have had obinutuzumab before
Have had an allergic reaction to similar drugs to obinutuzumab (your doctors can advise you about this)
Have CLL in your brain or spinal cord
Have CLL that has come back after treatment (relapsed)
Have a blood condition called active haemolysis unless it is controlled with steroids
Have certain heart problems (your doctors can advise you about this)
Have an infection that cannot be controlled or any other condition that could make it unsafe for you to take part in this trial
Have any other type of cancer, apart from a type of non melanoma skin cancer called basal cell carcinoma
Are HIV, hepatitis B or hepatitis C positive
Have had a vaccination with a live vaccine in the last month
Are pregnant or breastfeeding

Trial design

This is a phase 2/3 trial. Researchers need 188 people to take part. People taking part in the trial will be in 1 of 3 treatment groups.

Before you are put into treatment groups, the doctors will need to see if there are any remaining leukaemia cells (minimal residual disease or MRD). They will do this by taking a blood test. If they find MRD you will also need a bone marrow test.

If your blood test shows you have no MRD you will not need a bone marrow test. The doctors will ask you to go the hospital once a year for 3 years for a blood test. After that, the researchers will check how you are once a year. If at any time your doctor thinks you need to have treatment for your CLL they will discuss this with you.

If your blood test shows you have MRD you will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.

Half the people taking part will have obinutuzumab. The other half will have regular hospital appointments. This would be standard care after successful treatment for CLL if you weren’t taking part in the trial.

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If you are in the group having obinutuzumab, you have it through a drip into a vein every week for 4 weeks and then every 2 weeks for the next 2 months.

The trial team will ask everybody taking part in these 2 groups to complete some questionnaires before their treatment starts and then at regular periods throughout their treatment. They ask about how the treatment affects different areas of your life such as how you feel physically and emotionally. This is called a quality of life study. Completing these questionnaires is optional. If you do not want to do this, you can still take part in the trial.

If you decide to take part in this trial, your doctors may also ask for some extra blood samples and a saliva sample. The samples will be sent to the UK CLL Trials Biobank which is based at the Royal Liverpool University Hospital. The samples will be studied to see if we can improve how patients respond to treatment and possible new treatments. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part. These tests include

A physical examination
Blood tests

Your doctor may also ask you to have a

If you are in the group having obinutuzumab, you will need to go into hospital once a week for 4 weeks and then every 2 weeks for 2 months. The first time you have obinutuzumab, you have it split between 2 days. This is because there is a risk of reacting to the drug the first time you have it. You will have steroids and other drugs before having the obinutuzumab to reduce the chance of having a reaction. Throughout your treatment, you will have regular blood tests to make sure that you can continue to have the drug.

About 3 months after you finish treatment, you have an appointment with the trial team. You will have a physical examination, blood tests and a bone marrow test. You may also have a CT scan.

You have another hospital appointment 9 months after you start the trial and then every 3 months for 3 years. You will have regular blood tests at these visits. You will not need to visit the hospital for a check up between years 3 and 4. After 4 years, the trial team will ask to see you once a year for the rest of your life.

If you are in the group with MRD having no treatment, you go to hospital for a check up every 3 months for 3 years. This is what would usually happen after you finish treatment for CLL. At each visit, you will have a physical examination and blood tests. Your doctor may also ask you to have a CT scan. You will not need to visit the hospital for a check up between years 3 and 4. But 4 years after you joined the trial you will have a check up and blood test. After 4 years the trial team will ask to see you once a year for the rest of your life. If at any time your doctor thinks you need to have treatment for your CLL they will discuss this with you.

If you are in the group who had no MRD you will need to go the hospital once a year for 3 years for a blood test. After that, the researchers will check how you are once a year.

Side effects

As obinutuzumab is a new drug there may be side effects that are not known about. Known side effects include

An immediate reaction during the obinutuzumab drip. You may feel hot, flushed, shivery, dizzy, tired, or short of breath, or you may feel or be sick and your blood pressure may go up or down
A severe allergic reaction (anaphylaxis)
An increased risk of infection
Bruising more easily due to a drop in the number of blood cells called platelets which can cause nosebleeds, bleeding gums after brushing your teeth, or lots of tiny red spots or bruises on your arms or legs (known as petechiae )
Breakdown of tumour cells (tumour lysis syndrome) which can cause high levels of certain chemicals in your body
Hepatitis B (a viral infection affecting the liver) can flare up (reactivate), but this is rare
A rare brain infection called progressive multifocal leukoencephalopathy (PML). You must tell your doctor or nurse straight away if you have memory loss, trouble communicating, difficulty walking or loss of vision
Existing heart conditions can get worse