CLL 5 Trial
The Value of Autografting Younger Patients with High Risk Chronic Lymphocytic Leukaemia (CLL)
Introduction
Chronic Lymphocytic Leukaemia (CLL) is a common type of adult leukaemia which although incurable, often doesn’t
affect an individual’s life expectancy as it tends to be diagnosed in older people. However, around 20% of
patients are younger with fairly widespread and advanced disease which, if left untreated, will inevitably
shorten their life. If you have been asked to participate in this trial your CLL must be considered by your
doctor to be advanced. This is sometimes known as high risk CLL. In the case of high risk CLL the symptoms can
be controlled fairly well by treatment and remission can be achieved but it is highly likely that the disease will
come back (relapse).
How is this Trial Run?
This trial is known as a randomised control trial. A randomised control trial is a trial in which patients with
similar disease traits are selected by a computer to be placed in different groups that are comparing different
treatments. There is no way at the time for researchers to know which of the treatments is best and neither you
nor your doctor get to choose which treatment you have.
Do I have to take part?
No. You are a key member of the health care team and it is completely up to you whether you want to be involved
in this trial. You have a right to say no or withdraw at any time without your ongoing care or treatment being
affected. If you do choose to take part you will be given lots of information and asked to sign a consent form.
What is the aim of this trial?
At the moment the standard approach for high risk CLL is to give chemotherapy treatment to induce remission but
then not to give further treatment until such times as the disease comes back (relapse). At this point the treatment
of choice would normally be an autologous stem cell transplant (using stem cells from your own body rather than a
donor).
What isn’t known is whether it is of advantage to patients to have an autologous stem cell transplant at the earlier
stage before relapse. So this trial looks to compare no further treatment until relapse and an autologous stem cell
transplant at the point of remission to see whether early transplantation makes a difference to survival. Patients
in the no further treatment group may still receive a transplant at a later stage.
What is an autologous stem cell transplant?
Stem cells are very young blood cells in your body which develop into red blood cells, white blood cells and
platelets. The high dose chemotherapy which is necessary to kill off your leukaemia cells also destroys these
healthy blood forming cells and the collected stem cells help your body to recover.
How are stem cells collected?
In order to collect your stem cells you will be given a dose of chemotherapy and a seven day course of a drug
called G-CSF. G-CSF is given as an injection under your skin once a day and your nurse can teach you how to do
this yourself or arrange for a district nurse to give the injection. G-CSF works by increasing the number of stem
cells in your blood. Your stem cells will then be collected by filtering your blood through a special machine.
The stem cells can then be cooled and stored ready for use when you need them.
Who can enter this trial?
You may be asked to enter this trial if you meet the following criteria:
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You are aged over 18
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You have a confirmed diagnosis of B CLL CD5+/CD23+
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Your disease has responded to treatment so far
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You have a reasonable heart, liver and kidney function
What might stop me from entering this trial?
You won't be asked to enter this trial for the following reasons:
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If you are too unwell to take part in the trial
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If you have another serious illness such as HIV
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If you are pregnant
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If it is already planned for you to have a stem cell transplant from a donor
What might being entered in this trial mean to me?
Before you enter the trial you will have a number of tests. This will tell your health care team about your general
health and whether you are eligible for the trial or not.
The investigations may include:
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A CT scan
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Blood tests
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A bone marrow biopsy
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Physical examination
This trial will mean some overnight hospital stays for you. The number of nights depends on the phase of the trial
you are in and the group you are randomized to.
For both groups the initial chemotherapy will mean regular visits to the hospital as an outpatient in order to have
chemotherapy. This chemotherapy is designed to control your disease (remission).
As stated before there is a strong chance that your disease will come back after remission. This is called relapse.
At the point of relapse you will have further chemotherapy which will again mean you have to come to the hospital
as an outpatient for treatment.
At this point you will be randomised to either no further immediate treatment or stem cell transplant.
Regardless of the group you are in you will have your stem cells collected.
What happens if I am randomised to the no further treatment group?
If you are in this group the doctors will collect your stem cells and observe you closely with a view to giving
you a stem cell transplant in the future if/when your disease comes back.
What happens if I am randomised to the autologous transplant group?
After you have recovered from the stem cell collection you will go onto the stem cell transplant. During this phase
you will receive high dose chemotherapy (and in some centres radiotherapy). These treatments are given at a higher
dose than your previous chemotherapy/radiotherapy combinations.
Approximately a week after you start your high dose therapy you will be given back your stem cells through an
infusion. This is painless and will look and feel like having a blood transfusion. In total the high dose
chemotherapy and stem cell transplant should keep you in hospital for about a month.
What happens next?
Regardless of the group you are in you will be followed up closely by your doctor. As a minimum you will have
an appointment every 4 months in the first year and then every six months for the following two years. Both
groups will have blood tests and examinations at this time. If you have had a transplant you will also need
to give a bone marrow sample at each visit
Side effects
As with other treatments there are some side effects which you should know about. Your doctor or nurse can give
you much more detailed information on these effects and how you might manage them.