Chronic Lymphocytic Leukaemia (CLL) / Posted 3 years ago

ALL-RIC:A trial comparing treatments for acute lymphoblastic leukaemia
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.

  • Inclusion Criteria :
    • have ALL and this is the first 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 65 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)
  • Exclusion Criteria :
    • can’t have a low intensity stem cell transplant
    • 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
  • Study start date : 17/09/2018
  • Study end date : 17/09/2022
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Professor David Marks

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