ANIMATE

 Classic Hodgkin lymphoma / Posted 1 year ago

A trial of nivolumab for Hodgkin lymphoma

This trial is looking at whether nivolumab can improve treatment before a stem cell transplant for people with Hodgkin lymphoma.

  • Inclusion Criteria : You may be able to join part 1 of this trial if all of the following apply.
    • have Hodgkin lymphoma that has come back after your first chemotherapy treatment or it didn’t work very well
    • are due to have, are having or have had (within 14 days), 2 cycles of chemotherapy as your first or second salvage treatment
    • are well enough to have a stem cell transplant with your own cells
    • are willing to use reliable contraception if there is any chance you or your partner could become pregnant
    • are at least 16 years old
    • You might be able to join part 2 and have nivolumab if the following apply.
    • joined part 1 of this trial
    • have had 2 cycles of salvage chemotherapy for Hodgkin lymphoma (or 4 cycles of treatment if you had a drug called brentuximab vedotin) had the salvage chemotherapy but a PET-CT scan showed it didn’t work well enough to go on and have a stem cell transplant
    • are well enough to have more chemotherapy
    • are well enough to take part and to carry out all your normal activities apart from heavy physical work (performance status of 0 or 1)
    • are willing to use reliable contraception during treatment with nivolumab and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
    • have satisfactory blood test results
  • Exclusion Criteria :
    • have a type of Hodgkin lymphoma called nodular lymphocyte Hodgkin lymphoma
    • have inflammation of the bowel or lung
    • have an autoimmune condition apart from vitiligo, diabetes, or a problem with your thyroid gland that doesn’t need treatment
    • are allergic to drugs called monoclonal antibodies
    • have had surgery within 4 weeks of joining the trial
    • have had a heart problem such as a heart attack in the last 6 months
    • have had any other cancer in the last 3 years apart from basal cell skin cancer , squamous cell skin cancer or certain early cancers
    • have an active hepatitis B or hepatitis C infection have HIV
    • are pregnant or breastfeeding
    • had salvage chemotherapy and the chemotherapy worked well had chemotherapy, radiotherapy or steroids of more than 10mg a day within 14 days of having a PET-CT scan
    • have an active infection that needs treatment
    • are having treatment to dampen down your immune system apart from creams, nose sprays or low dose steroids
    • are having or have had an experimental treatment as part of another trial with 28 days of starting nivolumab
    • have side effects from treatment that haven’t got better apart from hair loss or moderate tiredness
    • are pregnant or breastfeeding
  • Study start date : 03/12/2018
  • Study end date : 03/12/2021
  • Wales-Based Study Contact : Not recruiting in Wales
  • Principal Investigator : Dr Graham Collins

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