SPARKLE

 Paediatric Cancers / Posted 1 year ago

A trial looking at ibrutinib and standard treatment for children and young adults with B cell non-Hodgkin lymphoma

This trial is for children and teenagers with a type of acute lymphoblastic leukaemia called pre cursor B cell ALL that has come back after initial treatment.

  • Inclusion Criteria :
    • have B cell non-Hodgkin lymphoma (NHL) such as Burkitt lymphoma, diffuse large B cell lymphoma (DBCL) or other childhood B cell lymphomas
    • have had your first treatment but the lymphoma has come back, or the standard treatments have stopped working
    • have an area of lymphoma that measures at least 1cm across on a scan, you have bone marrow involvement or you have lymphoma in the spinal fluid (CSF )
    • have satisfactory blood test results
    • need quite a lot of help to care for yourself (Karnofsky performance scale 50 or more) or you get dressed but need to lie down for much of the day and only take part in quiet play and activities (Lansky play scale 50 or more)
    • are willing to use reliable contraception during treatment and for 3 months after the last dose of ibrutinib if you are sexually active and there is any chance you or your partner could become pregnant or for at least 1 year after the last dose of RICE or RVICI
    • are between 1 years old and 30 to join part 2 if you were diagnosed with NHL under the age of 18
  • Exclusion Criteria :
    • have had ibrutinib in the past
    • have had a stem cell transplant in the last 6 months
    • developed lymphoma after having a stem cell transplant or an organ transplant (this is called post transplant lymphoproliferative disease or PTLD)
    • have had an experimental treatment or device within 30 days of starting trial treatment
    • are having treatment to thin the blood such as warfarin
    • have a problem with how your blood clots
    • you take medication that blocks a substance called CYP3A4/5
    • have problems with your heart, such as an abnormal heart rhythm or it is weak
    • have a problem with your digestive system that means you can’t absorb ibrutinib properly
    • have had major surgery within 4 weeks of joining the trial, have surgery planned during the trial or you haven’t fully recovered from an operation have HIV
    • have an active hepatitis B or hepatitis C infection
    • have any other medical condition or mental health problem that the trial team think would affect you taking part
    • are pregnant or breastfeeding or planning a pregnancy within 3 months of stopping ibrutinib or within a year of stopping the other drugs in the trial
    • are allergic to ibrutinib, any of the other drugs in the trial or anything they contain
  • Study start date : 17/01/2017
  • Study end date : 30/03/2021
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Prof Amos Burke

No post found