RAMO-2: a randomised, phase 3 trial comparing original rituximab with the biosimilar rituximab SAIT101 in people with untreated follicular lymphoma

The aim of this trial is to compare a biosimilar rituximab with the original rituximab in people with untreated follicular lymphoma who do not have troublesome symptoms. 


    Purpose of trial

    The trial is comparing:

    • the safety of the 2 versions of rituximab 
    • how effective they are at treating follicular lymphoma
    • how they affect your immune system.

    Treatments

    A biosimilar is a medicine developed to be highly similar to an existing medicine. Biosimilars are tested to make sure they have the same quality, safety and efficacy (how well they work) as the original medicine. Biosimiliars may be cheaper than the original drug. The money saved could then be used by the NHS for other purposes.

    SAIT101 is a biosimilar of rituximab. Rituximab is widely used for the treatment of many types of non-Hodgkin lymphoma.

    Participants are randomised to receive SAIT101 (biosimilar rituximab) or MabThera® (original rituximab). You can’t choose which treatment you have and neither can your doctor. The trial is ‘double blind’, which means you are not told which treatment you have and neither is your doctor.

    Both medicines are given by intravenous infusion (through a drip into a vein) once a week for 4 weeks. You have regular follow-up appointments as part of the study for 1 year after starting treatment.


    Who can enter

    Your consultant can give you advice on whether this trial might be suitable for you.

    Around 308 people are needed for this trial.

    You may be able to enter if:

    • You have follicular lymphoma with a low tumour burden (the amount of lymphoma in your body is low).
    • Your lymphoma is stage 2 to 4A and grade 1, 2 or 3a.
    • You do not have B symptoms (night sweats, fevers, weight loss).
    • Your lymphoma is measurable by the tests used in the trial.
    • Your blood and other health test results are satisfactory.
    • You have not previously received treatment for your lymphoma unless it was radiotherapy for localised disease (lymphoma in 1 or few places).
    • You are 18 or over.

    You will not be able to enter if:

    • You have received previous treatment with chemotherapy, rituximab or another antibody therapy.
    • You have had radiotherapy in the last 28 days.
    • You are likely to need another anti-cancer treatment while you are participating in the trial.
    • You are being treated with steroids at a dose greater than 20 mg per day of prednisolone or an equivalent dose of another steroid.
    • Your lymphoma has transformed (changed) into a high-grade (fast-growing) type of lymphoma.
    • You have had another cancer in the last 5 years, except certain localised cancers.
    • You have had major surgery in the last 28 days.
    • You have HIV, hepatitis C or hepatitis B or another type of immunodeficiency (low immune system).
    • You have a serious or persistent infection that makes you unsuitable for treatment that affects your immune system.
    • You have tuberculosis.
    • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
    • You have significant heart problems, problems with your blood pressure or have had a stroke.
    • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
    • You’ve had a bad reaction to a similar drug or any of the ingredients of the trial treatment in the past.
    • You have been treated with another experimental treatment in the last 4 weeks.
    • You have had a live vaccine in the last 6 weeks. Your doctor can advise you if this applies to any vaccines you have had.
    • You are pregnant or breastfeeding or plan to become pregnant during treatment or within 1 year of receiving the trial treatment.

    Further information

    More information about this trial is available at clinicaltrials.gov