Purpose of trial
This trial is comparing the combination of ofatumumab and bendamustine with the combination of ofatumumab and chlorambucil for people with chronic lymphocytic leukaemia (CLL) who can’t have more intensive chemotherapy.
CLL is usually treated with chemo-immunotherapy that combines the chemotherapy drugs fludarabine and cyclophosphamide with the antibody treatment rituximab - a combination known as FCR. Although FCR can be very effective, it can cause serious side effects and many people are not well enough to have it. Such people are often given rituximab with a gentler chemotherapy drug like chlorambucil or bendamustine.
Ofatumumab is an antibody treatment that targets the same protein (CD20) as rituximab. It is already used to treat some people with CLL but researchers want to find out which combination of chemotherapy and ofatumumab is the most effective.
Participants are randomised to decide which of the 2 chemo-immunotherapy regimens they have:
- ofatumumab and chlorambucil
- ofatumumab and bendamustine.
You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.
You have ofatumumab and bendamustine intravenously (by a drip into a vein). You take chlorambucil as tablets orally (by mouth).
In both groups you have treatment in 4-week cycles with the drugs given on some days followed by a rest period for your body to recover before the next cycle of treatment.
If you are in the ofatumumab and chlorambucil group, you have up to 12 cycles of treatment.
If you are in the ofatumumab and bendamustine group, you have up to 6 cycles of treatment.
After treatment, you have regular check-ups (follow-up). You are also asked to complete questionnaires during your treatment and follow-up so researchers can track your progress and see how the treatment and your lymphoma affect your quality of life.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 504 people are needed for this trial.
You may be able to enter if:
- You have CLL or small lymphocytic leukaemia (SLL) and need treatment.
- You haven’t had any other anti-cancer treatment for your CLL.
- You can’t have the standard FCR treatment.
- Your health and blood test results show that you are fit enough to have chlorambucil at the dose used in this study.
- You are over 18.
You will not be able to enter if:
- You have low neutrophils (a type of white blood cell that fights infection) or low platelets (which help your blood to clot), unless these are related to your CLL.
- You have autoimmune haemolytic anaemia or thrombocytopenia unless it is well controlled.
- You have an infection.
- You have HIV, hepatitis B or hepatitis C.
- Your CLL is in your central nervous system (CNS; brain and spinal cord).
- Your CLL has transformed into a more aggressive form.
- You have had another cancer in the last 3 years except certain localised cancers.
- You have severe kidney or liver problems.
- You need treatment with steroids (unless under a certain level; ask your doctor for details).
- You have had another antibody treatment in the last 3 months or a treatment as part of another clinical trial in the last 30 days.
- You have had a yellow fever vaccination in the last 4 weeks.
- You have had major surgery in the last 4 weeks.
- You have serious heart problems.
- You have any other health conditions that the doctor thinks makes it unsafe for you to enter the trial.
- You can’t have the study drugs because of allergies or other health problems.
- You are pregnant or breastfeeding or unwilling to use reliable contraception during treatment and for at least a year after treatment.
More information about this trial is available at clinicaltrials.gov.