AVENuE

  • Research type

    Research Study

  • Full title

    Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study

  • IRAS ID

    242136

  • Contact name

    Graham Collins

  • Contact email

    Graham.collins@ouh.nhs.uk

  • Sponsor organisation

    University College London

  • Eudract number

    2018-002227-42

  • Clinicaltrials.gov Identifier

    NCT03617666

  • Duration of Study in the UK

    2 years, 7 months, 1 days

  • Research summary

    This study is to test a drug called avelumab, in addition to standard chemotherapy, for advanced Hodgkin lymphoma.

    So far, avelumab has only been used in people with Hodgkin lymphoma that has come back after earlier treatment. Research shows that it can reduce disease in this situation.

    Although standard chemotherapy works for lots of people, doctors now wonder whether adding avelumab from the beginning of treatment might make it better. It may increase the number of people cured and reduce the rate of relapse. It may reduce the amount of chemotherapy needed, and therefore reduce risk of long term side effects.

    Patients will have the same treatment that they would have otherwise PLUS the extra drug, avelumab, which is given first. This will mean two months of extra treatment before they begin chemotherapy.
    They will be treated with a new drug, avelumab. It has already been tested on people who have had chemotherapy before. However, it has not been tested on newly diagnosed people before chemotherapy.
    Their total treatment time will be 2 months longer than usual – about 8 months instead of 6.

    In this study, 47 adult patients with untreated classical Hodgkin lymphoma will be given avelumab before chemotherapy. Patients will be seen regularly during treatment, every 3 months until a year after treatment and then annually until the last patient completes a year of follow up.

    The study will be conducted at NHS hospitals and is expected to last 5.5 years.

  • REC name

    South Central - Berkshire Research Ethics Committee

  • REC reference

    18/SC/0644

  • Date of REC Opinion

    24 Dec 2018

  • REC opinion

    Favourable Opinion