UKALL XII
Trial for Patients with Philadelphia-Positive Acute Lymphoblastic Leukaemia (ALL)
What is the aim of this trial?
This trial is designed to find out what the best treatment is for people with a type of Acute Lymphoblastic Leukaemia
(ALL) called Philadelphia positive (Ph+ve) ALL. Most of the drugs used in this trial are well established and have
been used to treat ALL for many years. The only new drug is called Imatinib (sometimes called Glivec) and the trial
seeks to find out whether this drug can improve the normal treatment of Ph+ve ALL.
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 will taking part in this trial mean for me?
There are four parts to this trial. These are called induction, consolidation, bone marrow transplant
and maintenance.
Part One: Induction
The first part of the protocol is called induction. Whether you have Ph positive or negative ALL this phase of
the treatment aims to kill off the leukemia cells in your bone marrow. In order to do this you will need two
courses of intensive chemotherapy which will be given in hospital over an eight week period. Everyone who has ALL
has the same initial treatment as sometimes it takes a couple of weeks after the start of treatment for the doctor
to find out whether you have Philadelphia positive ALL. If the doctors find you have Philadelphia positive ALL
then they will offer you a drug called Imatinib in the second course of induction chemotherapy.
Part Two: Consolidation
The drugs used in the induction phase are usually very good at destroying the leukemia cells in your body.
However, you need further treatment called consolidation to prevent the disease coming back.
This would be four weeks of Imatinib therapy which is given as a tablet once a day. You would not need to be in
hospital for this phase of your treatment.
Part Three: Bone Marrow Transplant
At this point your doctor may ask your permission to test any brothers or sisters you have to see if their bone
marrow matches yours. This would be to prepare for a bone marrow transplant which is the third phase of your
treatment if possible. If you don’t have a match from your siblings your health care team will seek an unrelated
donor for you. If you have no siblings or unrelated match then you would receive an autologous transplant which
uses your own blood cells. There is more information on allogeneic and autologous transplants at the end of this
page.
Part Four: Maintenance
After your transplant you will receive ongoing Imatinib. You will have regular bone marrow biopsies to check that
you are benefiting from Imatinib.
Who can enter this trial?
You may be asked to enter this trial if you meet the following criteria:
-
You have a confirmed diagnosis of Philadelphia positive (Ph +-ve) acute lymphoblastic leukemia.
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You are aged between 20 and 65 (an exception to this is if you are aged between 15 and 20 and have previously
been registered to the UKALL 2003 trial and have been found to be Ph +ve)
-
Your ALL has not been treated (unless you are transferring from the UKALL 2003 trial)
What might stop me from entering this trial?
You won't be asked to enter this trial for the following reasons
-
If you have received chemotherapy or radiotherapy for cancer in the past
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If you have had a previous haematological disorder such as AML, CML or a myelodysplastic syndrome.
-
If you have had previous therapy for ALL other than steroids
(an exception is if you have transferred from the UKALL 2003 trial to this trial)
-
If you have another serious life threatening illness
-
If you are pregnant or breastfeeding
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:
-
A CT scan
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Blood tests
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A bone marrow biopsy
-
Physical examination
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.
What is an allogeneic bone marrow transplant?
Leukemia is a disease of the bone marrow which is the tissue in your body which manufactures blood cells. A bone
marrow transplant uses high dose chemotherapy and/or radiotherapy to destroy your diseased bone marrow and then
replace this with healthy bone marrow. You should expect to be in hospital for 6 to 8 weeks. The replacement marrow
can come from a donor whose cells have to be matched with yours but they can be a sibling, a relative or an
unrelated person found through the bone marrow registry.
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 may 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.