A trial comparing treatments for acute lymphoblastic leukaemia (ALL-RIC)

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

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is looking at a new combination of treatment for acute lymphoblastic leukaemia (ALL).

It is for people:

who have no signs of leukaemia in the blood or bone marrow (complete remission)
over the age of 40 and under 70

More about this trial

Doctors are looking for new ways to treat people with acute lymphoblastic leukaemia (ALL) to stop the leukaemia coming back. In this trial, they are comparing a usual treatment with a new combination of treatment.

The usual (standard) treatment in this trial is a combination of drugs called FMA. It includes:

fludarabine – a chemotherapy drug
melphalan – a chemotherapy drug
alemtuzumab – a targeted drug

The new combination of treatment includes:

cyclophosphamide – a chemotherapy drug
alemtuzumab – a targeted drug
radiotherapy to the whole body (total body irradiation or TBI)

Everyone then goes on to have a stem cell transplant with stem cells from another person (an allogeneic stem cell transplant). The chemotherapy and radiotherapy in this trial are low intensity. This is to reduce the possible complications of a transplant.

We know from early research that the new combination of treatment works well and seems to have fewer side effects than FMA. But researchers need to find out for sure, so they are checking this in more people.

The main aim of the study is to compare treatments to see which works best to prevent the leukaemia coming back.

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.

Who can take part

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

You:

have ALL and this is the first time or second time you have had no signs of leukaemia in the blood or bone marrow (complete remission)
have suitably matched cells for the stem cell transplant
are suitable to have low intensity treatment and an allogeneic stem cell transplant
have satisfactory blood test results
are well enough to be up and about for at least half the day (performance status 0,1 or 2)
are willing to use reliable contraception during treatment and for 12 months afterwards if there is any chance you or your partner could become pregnant
are between 40 and 70 years old (you might be able to join if you are under the age of 40 if you aren’t suitable to have high dose chemotherapy and a stem cell transplant)

Who can’t take part

You cannot join this trial if any of these apply.

You:

can’t have a low intensity stem cell transplant
have had radiotherapy in the past
have side effects from past treatment apart from your bone marrow not making enough blood cells such as red cells or white cells (bone marrow suppression)
have problems with your heart or lung unless your doctor says you are suitable to have total body irradiation when you join the trial
have another type of cancer
had another type of cancer in the past unless there is a low risk of it coming back
have a problem with the way your kidneys and liver work
have an active infection
have HIV
have an active hepatitis A or hepatitis C infection
are pregnant or breastfeeding

Trial design

This phase 2 trial is taking place in the UK. The researchers need 247 people to join.

It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

You have 1 of the following treatments:

fludarabine, melphalan and alemtuzumab (usual treatment)
cyclophosphamide, alemtuzumab and total body irradiation (new treatment)

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Fludarabine, melphalan and alemtuzumab (FMA)

You have a combination of the drugs fludarabine, melphalan and alemtuzumab. You have them as a drip into a vein over 7 days. You then have your stem cell transplant.

Cyclophosphamide and TBI

You have:

cyclophosphamide and alemtuzumab as a drip into a vein
4 doses of total body irradiation

You have this over 7 days before your transplant.

A radiotherapist Open a glossary item

will give the total body irradiation (TBI). You have this twice a day over 2 days as part of the 7 day treatment before the transplant.

You may also have a CT scan Open a glossary item

or test dose before the TBI. This allows the radiotherapists to work out the correct dose to give to protect your organs.

You then have your stem cell transplant.

Quality of life

The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study Open a glossary item

The questionnaires shouldn’t take longer than 20 minutes to complete. You may find some of the questions distressing. Please speak to your doctor or nurse if you find any of the questions distressing. They’ll be able to support you.

Hospital visits

You’ll see a doctor and have some tests before you can take part. These include:

physical examination
blood tests
breathing tests (lung function tests)
bone marrow test

You have all your treatment in the hospital. You will stay in for about 2 to 4 weeks.

After you are discharged from the hospital you have check ups as follows.

Blood tests:

every week for 1 month
every 3 months for 2 years
every 6 months to a year for 3 years

A bone marrow test:

at 100 days
at 6 months
every 3 months for 2 years
every 6 months for 3 years

A lumbar puncture test:

at 100 days
at 6 months in the first year
every 3 months for 2 years

Side effects

Having cyclophosphamide, alemtuzumab and TBI is a new treatment for ALL. So, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The most common side effects of cyclophosphamide are:

an increased risk of infection
hair loss
blood in the urine
bladder inflammation
fever

The most common side effects of alemtuzumab include:

an increased risk of infection
an allergic reaction to the drug, for example, flu like symptoms such as fever and chills

The possible short term side effects of total body irradiation are:

feeling sick
tiredness
diarrhoea
a dry, sore mouth
hair and body hair loss
sensitive skin (your skin may go pink, darken and be itchy and more sensitive to the sun)
an increased risk of infection
an increased risk of bleeding

The possible long term side effects of total body irradiation are:

sensitive skin
developing clouding of the lens of the eye (cataracts)
fertility problems for women and men
the risk of getting other cancers
changes to lung tissue which can cause breathlessness, coughing or wheezing
an underactive thyroid which can cause weight gain, tiredness, constipation and dry skin

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