A trial looking at RO5072759 and rituximab for chronic lymphocytic leukaemia

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)




Phase 3

This trial is looking a new drug RO5072759 or rituximab (Mabthera) with chlorambucil for chronic lymphocytic leukaemia (CLL).

Doctors often treat CLL with a combination of chemotherapy and a biological therapy. One chemotherapy drug they use is chlorambucil. One of the biological therapies they use is rituximab. But they haven’t used chlorambucil and rituximab together before to treat CLL.

RO5072759 is a biological therapy called a monoclonal antibody. It works in the same way as rituximab. The researchers think that RO5072759 may be better than rituximab.

This trial is comparing

  • Chlorambucil alone
  • Chlorambucil and rituximab
  • Chlorambucil and RO5072759

The aim of the trial is to find out more about these combinations of treatment and which is the best to treat CLL.

Who can enter

You may be able to enter this trial if you

  • You have B cell chronic lymphocytic leukaemia (B cell CLL) that tests positive for the protein CD20 – your doctor can confirm this
  • Your kidneys and liver work well enough – your doctor will test for this
  • You have satisfactory blood test results
  • You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if

Trial design

This is a phase 3 trial. It is an international randomised trial. There are 2 stages to this trial. In both stages you are put randomly into treatment groups.

In the first stage the trial the treatment groups  are

  • Chlorambucil
  • Chlorambucil and rituximab
  • Chlorambucil and RO50727259

This is to make sure the treatments are safe. In this stage 118 people will be recruited to have chlorambucil only. When the researchers are sure the treatments are safe, stage 2 will start.

In stage 2 the trial will continue to recruit to a total of 786 people. The treatment groups in this stage are

  • Chlorambucil and rituximab
  • Chlorambucil and RO5072759

Chlorambucil is a tablet. You should swallow the tablets with plenty of water. You have RO5072759 or rituximab as a drip into a vein.  Each takes about 3 to 5 hours to give. You have treatment every 4 weeks. Each 4 week period is called a cycle of treatment. You can have up to 6 cycles in total.

The researchers will ask you to fill in questionnaires before you start treatment and at regular times during and after treatment. These will ask how you have been and about any side effects you may have. This is called a quality of life study.

The researchers will also ask your permission to store your blood samples for a number of years after the end of the trial. They will use them to find out more about CLL. You don’t have to agree to this if you don’t want to. You can still take part in the main trial.

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests include

During treatment you see the doctor regularly for a physical examination and blood test.

When you finish treatment, you see the doctor after 1 and 3 months and then

  • Every 3 months up to 3 years
  • Every 6 months for at least 5 years
  • Every year for at least 8 years

Side effects

RO5072759 is a new drug and there may be side effects we don’t know about yet. But the most common side effects we know of so far are

You may have a reaction to RO5072759 causing fever, chills, changes in blood pressure, feeling or being sick, tiredness or a hot, red face. These happen mainly during, or shortly after, the first time you have it.

The most common side effects of rituximab can include

  • A drop in blood cells
  • Flu like symptoms
  • Feeling sick
  • Diarrhoea
  • Rash
  • Low blood pressure

You may have a reaction to rituximab during infusion, causing flu like symptoms such as a fever, chills and shivering (rigors), a headache and feeling sick – your doctor will give you medicines beforehand to try to prevent a reaction. If you do have a reaction, your nurse will slow or stop your drip for a while.

The most common side effects of chlorambucil can include

  • A drop in blood cells
  • Feeling or being sick
  • Diarrhoea
  • Mouth ulcers

We have more information about rituximab and chlorambucil in our cancer drugs section.

Recruitment start:

Recruitment end:

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.

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

Chief Investigator

Dr Christopher Fegan

Supported by

Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6323

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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