Purpose of trial
The aim of the trial is to find out if a combination of new treatments, ublituximab and umbralisib (also called ‘TGR-1202’), is as safe and effective as a standard combination of obinutuzumab and chlorambucil for people with chronic lymphocytic leukaemia (CLL) that needs treatment.
Ublituximab and obinutuzumab are newer antibodies to CD20, the target for rituximab, which is an antibody treatment that is widely used for CLL. Obinutuzumab may be more effective than rituximab for some people and is now also being used to treat CLL. Ublituximab is being tested to see if it is more effective than obinutuzumab.
Umbralisib is a type of treatment called a cell signal blocker. It blocks signals that B cells send to help them stay alive and divide. It works in a similar way to idelalisib, which is a cell signal blocker that is already used for CLL.
Chlorambucil is a chemotherapy drug widely used to treat CLL.
This is a randomised trial. Participants are randomly assigned to one of two groups:
- group 1 have ublituximab and umbralisib
- group 2 have obinutuzumab and chlorambucil.
You can’t choose which group you are in and neither can your doctor. You are told which treatment you are receiving and given information about it.
Some people in this trial are having ublituximab or umbralisib alone but the trial is now only recruiting people to have the combination treatments.
If you are group 1, you have:
- ublituximab given intravenously (into a vein) 3 times in the first month of treatment then given once a month for 5 more doses. After this, you have ublituximab once every 3 months.
- umbralisib tablets, which you take orally (by mouth) every day.
You continue to have ublituximab once every 3 months and to take umbralisib tablets every day for as long as the treatment is helping you.
If you are in group 2, you have treatment for 6 months. You have:
- obinutuzumab given intravenously 3 times in the first month of treatment then given once a month for up to 5 more doses
- chlorambucil tablets, which you take orally twice a month for 6 months.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 450 people are needed for this trial.
You may be able to enter if:
- You have CLL and need treatment. Both people who have had no previous treatment and those who have received previous treatment but need more treatment are eligible for this trial.
- You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work.
- You are 18 or over.
You will not be able to enter if:
- Your lymphoma has transformed (changed) into a faster-growing type of lymphoma. You might hear this called ‘Richter’s syndrome’.
- You have previously been treated with obinutuzumab, chlorambucil or a PI3K delta inhibitor like idelalisib.
- You have had major surgery, chemotherapy or immunotherapy (for example antibody treatment) in the last 3 weeks.
- You have had an autologous stem cell transplant in the last 3 months.
- You have ever had an allogeneic stem cell transplant.
- You have HIV, hepatitis B or hepatitis C.
More information about this trial is available at clinicaltrials.gov.