A trial looking at alemtuzumab after chemotherapy for chronic lymphocytic leukaemia (CLL) - CLL207 MRD Eradication Study

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

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is trying to find out if the drug alemtuzumab (Mabcampath) can reduce the small number of leukaemia cells that may be left in your blood after treatment for chronic lymphocytic leukaemia (CLL).

Doctors often treat CLL with chemotherapy. But unfortunately there are sometimes a small number of leukaemia cells still in the blood after the treatment has finished. This is called minimal residual disease (MRD). If these cells start to grow again, your leukaemia will come back (recur).

Alemtuzumab is a type of biological therapy, called a monoclonal antibody. At the moment, it is used to treat some people with CLL who have not responded to treatment with chemotherapy.

This trial will treat people who still have a small number of leukaemia cells left after chemotherapy (MRD positive). And people who had no leukaemia cells at the end of their chemotherapy (MRD negative), but who become MRD positive again later on.

The aims of this trial are to find out

  • How well alemtuzumab works for people who are MRD positive
  • More about the side effects

Who can enter

You can enter this trial if you

  • Still have B cell chronic lymphocytic leukaemia (CLL)
  • Have only a small number of leukaemia cells in your blood after your treatment, or there are no leukaemia cells in your blood after treatment
  • Finished your last treatment at least 6 months ago, but no more than 1 year ago
  • Have satisfactory blood test results
  • Are prepared to use reliable contraception while you are taking part in the trial if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have a lot of leukaemia cells in your blood after your last treatment
  • Have lymph nodes that are 2cm in diameter or bigger
  • Have leukaemia cells in the brain or spinal cord
  • Have had more than 3 different treatments for your chronic lymphocytic leukaemia
  • Have had a stem cell transplant using cells from someone else (allogeneic transplant)
  • Have had an experimental treatment within the last 6 weeks as part of another clinical trial
  • Have mantle cell lymphoma
  • Have an infection
  • Have ever had a serious allergic reaction to this or a similar monoclonal antibody
  • Have had alemtuzumab before and it hasn’t worked for you
  • Have any other serious medical condition
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit up to 54 people. Everyone taking part will be monitored to see if they have leukaemia cells remaining in their blood after their leukaemia treatment. If they do, they will have alemtuzumab (Mabcampath).

If you have a small number of leukaemia cells in your blood (MRD positive) you will start treatment straight away.

If you have no leukaemia cells in your blood at the moment (MRD negative), you won’t start the treatment at this time. You will see the doctors and have blood tests every 3 months. If the tests ever show that some leukaemia cells have come back, you will then start the treatment.

You will have alemtuzumab as an injection under the skin (subcutaneous injection) 3 times a week for 6 weeks. You will have some tablets, including steroids before you have the alemtuzumab. These help reduce side effects.

You will have a blood test each week. After 6 weeks of treatment, you will also have a bone marrow test.

If the tests show that the treatment is working, but there are still some leukaemia cells in your blood, you will have another 6 weeks of treatment.

If the tests show that you still have the same amount of leukaemia cells (or more) in your blood, you will stop the injections. Your doctor will discuss further treatment options with you.

If the tests show that there are no leukaemia cells in your blood (MRD negative), you will stop the injections. If you have no leukaemia cells in your blood for at least 6 months, but then blood tests show that some have come back again, you may have another 6 weeks of treatment.

Hospital visits

You will go to the hospital to see the doctors and have some tests before you take part in the trial. These include

You may also have a CT scan.

You will have blood tests every week while you are having treatment and a bone marrow test after 6 weeks. If you have a further 6 weeks of treatment, you will have another bone marrow test at the end of it.

You will have to go to the hospital 3 times a week for the alemtuzumab injection.

After the first 2 weeks, you may be able to give yourself the injections at home. But you will still need to go to hospital once a week to see your doctor and have the blood tests.

After you finish treatment, you will see the trial doctors every week for the first 4 weeks, every 2 weeks for the next 8 weeks, and then every 3 months after that. You will have blood tests each time.

Side effects

Some of the common side effects of alemtuzumab include

  • Flu like symptoms
  • A drop in blood cells causing an increased risk of infection, shortness of breath, tiredness and bleeding or bruising problems

You will take antibiotic tablets for at least 6 months after the treatment to try to prevent infections.

There is more information about alemtuzumab and its less common side effects on CancerHelp UK.

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

Prof Peter Hillmen

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Genzyme Therapeutics
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/06/038.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 826

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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