A trial looking at idasanutlin and cytarabine for acute myeloid leukaemia

 Acute myeloid leukaemia / Posted 1 year ago

This trial is for people whose acute myeloid leukaemia (AML) has come back or continued to grow following their first or second treatment.

  • Inclusion Criteria :
    • Have AML that has come back (relapsed) for a first or second time or has continued to grow following 1 or 2 courses of treatment
    • Have had no more that 2 induction treatments. One of these must have included treatment with cytarabine and an anthracycline drug, or anthracenedione such as mitoxantrone
    • 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 6 months afterwards if there is any chance that you or your partner could become pregnant
    • Are willing and able to have blood products
    • Are at least 18 years old
  • Exclusion Criteria :
    • You are younger than 60 years of age (including age 60),
    • You had a complete remission for over 1 year following your first treatment and your AML has now come back (relapsed)
    • You have extramedullary AML
    • Your AML has affected your brain or spinal cord (CNS) and it is causing symptoms
    • Your AML has continued to grow (refractory) or come back (relapsed) within 3 months of treatment with a total dose of over 18g/m2 of cytarabine
    • You have had a transplant using stem cells from a donor (an allogeneic transplant) within 3 months of joining this trial
    • You have had treatment to suppress your immune system for graft versus host disease in the last 2 weeks
    • You have had treatment in a trial in the last month
    • Your AML developed because you had previous chemotherapy for another type of cancer
    • You have already had treatment with a drug similar to idasanutlin
    • You are having any other type of treatment for your AML within 3 months of starting treatment in this trial. You can still take part if you are having hydroxyurea or leukapherisis to keep the levels of white blood cells stable in your blood (although this must be stopped 24 hours before starting treatment in this trial)
    • You have any serious side effects from your previous treatment for your AML which are still causing you problems
    • You have had any other cancer in the last 5 years unless this cancer has not caused any problems and has not needed treatment in the last 2 years
    • You have another haematological condition such as myelodysplastic syndrome, aplastic anaemia, or myeloproliferative disease
    • You are taking drugs that target enzymes in the body called CYP2C8, OATP1B1/3 or CYP3A4 and this treatment can’t be stopped
    • You take blood thinning medication such as warfarin or aspirin and this can’t be stopped, you may be able to take part if you are taking low dose heparin
    • You have any other medical condition that is severe or uncontrolled. For example, hypertension or diabetes mellitus not properly controlled with medication
    • You have had a heart attack or stroke in the last 6 months
    • You have a heart condition called QTc prolongation, or a family history of QT syndrome, or you are taking drugs that cause QT prolongation
    • You have an infection which needs treatment, or you have recently had treatment for an infection
    • You have active or chronic hepatitis unless blood tests show you are clear from infection
    • You have significant liver scarring (cirrhosis) with Child-Pugh B and C
    • You have problems with very low or very high levels of electrolytes in your blood. Electrolytes include potassium, calcium and magnesium. You might be able to take part if you have treatment to correct this during the time the doctors are doing tests for you to be able to take part in the trial
    • You have HIV
    • You are allergic to the drugs used in this trial
    • You are pregnant or breastfeeding
  • Study start date : 01/09/2016
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : Dr Steve Knapper

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