A trial of tocilizumab for chronic lymphocytic leukaemia

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Open

Phase:

Phase 1

This trial is looking at tocilizumab before obinutuzumab with chlorambucil for people who haven’t had treatment for B cell chronic lymphocytic leukaemia (CLL).

More about this trial

Doctors can treat CLL with a chemotherapy drug called chlorambucil and a biological therapy Open a glossary item drug called obinutuzumab.

You might have an inflammatory Open a glossary item reaction to obinutuzumab causing a high temperature (fever), sickness, chills and weakness. If you have a bad reaction it might delay or stop your treatment.

You can have steroids, paracetamol and an antihistamine Open a glossary item before obinutuzumab. This is called pre medication. You have this to try and stop the reaction happening.

We know from research that when you have obinutuzumab the body releases a protein. And this protein causes the inflammatory reaction. Tocilizumab blocks this protein.

Researchers think that giving tocilizumab and the pre medication before obinutuzumab might be better than just the pre medication. In this trial the researchers will compare:

  • tocilizumab, pre medication, obinutuzumab and chlorambucil
  • dummy drug (placebo Open a glossary item), pre medication, obinutuzumab and chlorambucil 

The aims of the trial are to find:

  • how safe it is to have tocilizumab before the pre medication and obinutuzumab
  • how well it works

Who can enter

The following bullet points list 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.

You may be able to join this trial if you have chronic lymphocytic leukaemia (CLL) that is B cell type and has the CD20 protein.

You haven’t had treatment but need to start treatment because you are in one of the following situations. You have:

  • A drop in red blood cells Open a glossary item and platelets Open a glossary item that shows your bone marrow Open a glossary item is failing
  • A continuing drop in a type of white blood cell called lymphocytes Open a glossary item and you don’t have an infection
  • A very large spleen Open a glossary item that is getting worse or causing symptoms
  • Very large lymph nodes Open a glossary item that are getting worse or causing symptoms
  • Had an unintentional loss of 10% or more of your body weight in the past 6 months
  • Continuously had a high temperature for the past 2 weeks or more 
  • Had night sweats Open a glossary item for the past month or more without having an infection

And all of the following apply:

  • Your kidneys aren’t working very well or you have various other health problems that mean you are suitable for the trial
  • Your other blood test results are satisfactory
  • You are willing to use reliable contraception during treatment and for up to at least 18 months afterwards
  • You are at least 18 years old

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

Cancer related

Medical conditions

  • Have had another cancer in the past 5 years apart from some early cancers Open a glossary item that were successfully treated
  • Have a viral infection of the brain called PML
  • Have had a heart attack in the past 6 months or any other major heart problem such as unstable angina
  • Have severe lung problems such as obstructive pulmonary disease
  • Have other severe health problems such as liver disease
  • Have a current infection or an infection that keeps coming back apart from a fungal infection of the nail beds
  • Have had an infection in the month before starting treatment in this trial and you needed to have antibiotics through a drip (intravenous infusion Open a glossary item)
  • Have had treatment for tuberculosis (TB) in the past 3 years. You will have a test for this
  • Have HIV, hepatitis B, hepatitis C or human T-lymphotropic virus 1 (HTLV 1)
  • Have an inherited bleeding disorder such as haemophilia
  • Have had major surgery in the past 4 weeks

Other

  • Have already had treatment with tocilizumab
  • Have had a severe allergic reaction to any other drug similar to tocilizumab (a monoclonal antibody Open a glossary item)
  • Are allergic to the drugs or their ingredients used in this trial
  • Have had steroids in the past 2 weeks or in the past 4 weeks if treatment was more than for 5 days, unless they were skin creams
  • Are taking medication that affects how the immune system Open a glossary item works
  • Have had a live vaccine Open a glossary item or weakened (attenuated) vaccine within the month before starting treatment
  • Are taking another experimental drug as part of a clinical trial
  • Are taking medication that affects how your blood clots such as aspirin, warfarin or heparin unless you are able to stop taking it
  • Have had any other treatment that affects the B cells
  • Are pregnant or breastfeeding

Trial design

This is a phase 1b trial. The researchers need 60 people to join.

This is a randomised trial. Everyone taking part is put into 1 of 2 groups. Neither you nor your doctor can choose which group you are or know which group you are in. This is a double blind trial. The 2 groups are:

  • tocilizumab, standard pre medication, obinutuzumab and chlorambucil
  • dummy drug (placebo), standard pre medication, obinutuzumab and chlorambucil

Every 2 out of 3 people are put into the tocilizumab group.

Diagram showing trial randomisation

The first day of treatment is called day 1. You have tocilizumab or the dummy drug as a drip into a vein. You only have this once at the start of treatment. You have it 2 to 4 hours before obinutuzumab.

You have obinutuzumab as a drip into a vein. When you first start treatment you have it on:

  • day 1 and day 2
  • a week later on day 8
  • a week after this on day 15

You then have it once every 4 weeks. Each 4 week period is called a cycle of treatment. You have a total 9 doses of obinutuzumab over 6 cycles of treatment.

Chlorambucil is a tablet. When you start treatment you have chlorambucil on day 1 and day 15.  After this you have it on day 15 of each cycle of treatment. You take it for 6 cycles.

Quality of life
You fill in a questionnaire before each treatment, 1 month and 2 months after you finish treatment. The questions will ask about any symptoms you have and how you feel. This is called a quality of life study.

Samples
The researchers will ask for blood samples and samples of bone marrow. They use these to look for substances (biomarkers Open a glossary item) that might show how well the treatment is working. And to find what happens to obinutuzumab in the body.

Hospital visits

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

  • a physical examination
  • blood tests
  • urine test
  • chest x-ray
  • heart trace (ECG Open a glossary item)
  • bone marrow test unless one has been done in the past 3 months
  • CT scan

You see the doctor before each treatment for a physical examination and blood tests.

A month and 2 months after finishing treatment you see the doctor for a physical examination and blood tests. At 2 months you might have another CT scan and bone marrow test. 

Side effects

In this trial you have only 1 dose of tocilizumab. The most common side effects reported when tocilizumab has been used for a longer time 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)
  • a drop in white blood cells causing an increased risk of infection
  • a drop in platelets causing an increased risk of bruising and bleeding
  • an increase in the amount of cholesterol in the blood
  • breakdown of tumour cells (tumour lysis syndrome) which can cause high levels of certain chemicals in your body

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) Open a glossary item
  • 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

We have information on the side effects of chlorambucil.  

Location

London

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

Professor John Gribben

Supported by

Experimental Cancer Medicine Centre (ECMC)
F.Hoffmann-La Roche Ltd (Roche)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14051

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.”

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