A trial comparing different doses of ofatumumab in chronic lymphocytic leukaemia (COSMIC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is looking at different doses of ofatumumab in combination with chemotherapy for people with chronic lymphocytic leukaemia (CLL).

More about this trial

Doctors usually treat chronic lymphocytic leukaemia (CLL) with chemotherapy. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat.

In this trial, doctors want to use bendamustine or a combination of fludarabine and cyclophosphamide, with either the standard dose or a higher dose of ofatumumab.

Ofatumumab (pronounced off-ah-too-moo-mab) is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.

The aims of this trial are to find out

The best dose of ofatumumab to use in combination with chemotherapy
More about the side effects

Who can enter

You may be able to enter this trial if you

Have chronic lymphocytic leukaemia (CLL) that has come back following treatment
Have had at least 1 type of chemotherapy in the past
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are willing to use reliable contraception during treatment and for 12 months afterwards if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Are not well enough to have fludarabine chemotherapy or you have had it in the past and it did not help you - you can ask your doctor about this
Have CLL that has come back (relapsed) within 12 months of having treatment with fludarabine, cyclophosphamide and rituximab (FCR)
Have a change to a gene called 17p the doctor will test your bone marrow for this
Have had ofatumumab before
Have an infection that cannot be controlled or any other condition that could make it unsafe for you to take part in this trial
Have taken part in a drug trial in the last month
Have had another type of cancer, apart from carcinoma in situ or non melanoma skin cancer or any other cancer that was successfully treated at least 2 years ago
Have had a monoclonal antibody that targets the CD20 protein, such as rituximab, in the last 3 months
Have had a monoclonal antibody called alemtuzumab in the last 3 months
Have certain heart problems
Are HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding
Have blood test results that could make it unsafe to take part in the trial

Trial design

This trial will recruit 82 people from around the UK.

Everybody taking part has either bendamustine or a combination of fludarabine and cyclophosphamide to begin with. Your doctor will decide which of these treatments is best for you.

If you have bendamustine, you have it through a drip into a vein on the first two days of every 4 weeks. If you have fludarabine and cyclophosphamide, you have it daily for 5 days every 4 weeks. You may have these through a drip into a vein or as tablets. Each 4 week period is called a cycle of treatment.

Everybody taking part then has ofatumumab through a drip into a vein. This part of the trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. Everybody has treatment for up to 24 weeks (6 cycles).

People in group 1 have the standard dose of ofatumumab. You have this twice in your first cycle of treatment, and then once every 4 weeks after that.

People in group 2 have the higher dose of ofatumumab. You have it once a week for 8 weeks, and then once every 4 weeks after that.

If you agree to take part in this study, the researchers will ask for extra samples of blood and spit (saliva). If you don’t want to give extra samples for this trial you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

Blood tests
Physical examination
Heart trace (ECG )
CT scan
Bone marrow test
Chest X-ray

You see the doctors and have blood tests frequently while you are having treatment and again when you stop treatment.

When you stop treatment, you see the trial doctor 3 months later and have a physical examination, blood tests, a bone marrow test and a CT scan.

You then see the doctor every 6 months up to 2 years, then once a year. At these visits you will have a physical examination and blood tests. You may also need to have a CT scan and your doctor will discuss this with you.

Side effects

The most common side effects of fludarabine are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
A cough
Diarrhoea
Feeling or being sick
Fever
Tiredness (fatigue)

The most common side effects of cyclophosphamide are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Hair loss
Sore mouth
Changes in skin colour
Changes in taste
Feeling or being sick

The most common side effects of bendamustine are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
A rash
Tiredness (fatigue)
Sore mouth

The most common side effects of ofatumumab are

A cough
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
A rash
Fever and chills

Some people have an allergic reaction to ofatumumab. You will have some medication before each treatment to help stop this happening. And your nurse will keep a close eye on you while you are having treatment.

There is more information about bendamustine, fludarabine, cyclophosphamide and ofatumumab in our cancer drugs section.

Recruitment start:

02/10/2012

Recruitment end:

31/03/2016

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Hillmen

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Leeds Institute of Clinical Trials Research (University of Leeds)
Leeds Teaching Hospitals NHS Trust
Novartis
NIHR Clinical Research Network: Cancer