A trial looking at ibrutinib for chronic lymphocytic leukaemia (HELIOS)

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)
Non-Hodgkin lymphoma




Phase 3

This trial is looking at ibrutinib with bendamustine and rituximab for chronic lymphocytic leukaemia (CLL).

If you have chronic lymphocytic leukaemia (CLL), white blood cells called lymphocytes are cancerous. If the cancerous lymphocytes are in your lymph nodes Open a glossary item rather than in your blood, your doctors may call it small lymphocytic lymphoma (SLL). The treatments for CLL and SLL are the same.

When CLL stops responding to treatment or has come back after treatment, doctors may use a biological therapy drug and chemotherapy to treat it. They can use the biological therapy drug rituximab and the chemotherapy drug bendamustine. These can help but doctors are always looking for ways to improve treatment.

Ibrutinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

We know from research that ibrutinib can help people with CLL. The researchers think that giving ibrutinib with rituximab and bendamustine might be better than using just rituximab and bendamustine to treat CLL.

The aim of this trial is to compare ibrutinib, rituximab and bendamustine with rituximab and bendamustine to find out which is best to treat CLL. The researchers also want to find out how safe it is to give ibrutinib with rituximab and bendamustine.

Who can enter

You may be able to enter this trial if you have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) and you have at least one of the following

  • Your doctors can see your bone marrow Open a glossary item is getting worse because your red blood cell and platelet counts are dropping
  • You have a very enlarged spleen
  • You have very swollen lymph nodes
  • The number of white blood cells called lymphocytes Open a glossary item in your blood has doubled in the last 6 months
  • You have lost more than 10% of your body weight without dieting or any other explanation for the weight loss
  • You have had high fevers for at least 2 weeks without any sign of an infection
  • You have had night sweats Open a glossary item for at least a month


  • Your CLL or SLL continued to get worse during treatment or has come back after treatment
  • One of your white blood cells Open a glossary item called a B cell Open a glossary item has the CD5 protein and at least one of the CD19, CD20 or CD23 proteins
  • Your blood test results are satisfactory
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if

  • You have leukaemia or lymphoma of your brain or spine
  • You have Richter’s syndrome
  • Your cancer cells have part of the 17th chromosome Open a glossary item missing (17p13.1) – your doctor will test for this
  • You have had chemotherapy in the past 3 weeks – or 6 weeks if you’ve had chemotherapy drugs called nitrosoureas Open a glossary item
  • You have had radiotherapy in the past 3 weeks
  • You have had a monoclonal antibody as part of your cancer treatment in the past 4 weeks – your doctor can confirm this
  • You have had a monoclonal antibody that carries cancer drugs or radiotherapy to the cancer cells – your doctor can confirm this
  • You have had an anti cancer treatment that triggers your immune system to fight cancer in the past 10 weeks – your doctor can confirm this
  • You have had major surgery in the past month
  • You are taking an experimental drug as part of a clinical trial
  • You have already had bendamustine and your CLL didn’t respond to it or came back within 2 years
  • You have already had ibrutinib or a similar drug – your doctor can confirm this
  • You are to have a stem cell transplant or have already had one
  • You have a condition called autoimmune haemolytic anaemia Open a glossary item or a low platelet count (thrombocytopenia) that is not controlled
  • You are taking more than 20mg of steroids a day
  • You have had another cancer apart from successfully treated non melanoma skin cancer, carcinoma in situ of the cervix or another cancer that was treated to try and cure it, and there has been no sign of it for at least 3 years
  • You have had a stroke or a bleed in your brain in the past 6 months
  • You have had heart failure or a heart attack in the past 6 months or any other serious heart problem
  • You are taking blood thinning medication such as warfarin or a similar drug
  • You are taking medication that affects the CYP3A4 or CYP3A5 enzymes
  • You are known to be HIV, hepatitis B or hepatitis C positive
  • You have an infection that is not controlled or any other medical condition that could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit 580 people from different countries around the world. It is a randomised trial. 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. And neither of you will know which group you are in. This is called a double blind trial.

The groups are

  • Bendamustine, rituximab and a dummy drug (placebo)
  • Bendamustine, rituximab and ibrutinib

HELIOS trial diagram

Ibrutinib and the dummy drug are capsules. You take 3 capsules daily. You take them with a glass of water at the same time each day. You take them at least 30 minutes before eating or at least 2 hours after a meal. On the day you have your bendamustine and rituximab you shouldn’t take your capsules in the morning. You take them with you to the clinic and have them when told to.

Bendamustine and rituximab are liquids. You have them as an injection into a vein. You have them every 4 weeks. Each 4 week period is called a cycle of treatment.

You have up to 6 cycles of bendamustine and rituximab. You continue to have ibrutinib (or the dummy drug) as long as the treatment is helping you and the side effects aren’t too bad.

The researchers will ask for a number of blood samples on 2 occasions before your treatment starts. They will use these to find out how much of the drug is in your blood. You must agree to these blood samples if you want to take part in the trial.

They will also ask for a blood sample to look for a substance (biomarker Open a glossary item) that could tell them how well the drug is working.

The trial team will ask you to fill out a questionnaire before you start treatment and then at regular times during the trial. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to 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 tests. You have a CT scan every 3 months.

After treatment you see the doctor every 3 months for a physical examination, blood tests and bone marrow test. You have a CT scan every 3 months for 2 years and then every 6 months.

If your cancer gets worse you then see the doctor every 4 months.

Side effects

The most common side effects of ibrutinib include

Your doctor will talk to you about the possible side effects before you agree to take part in the trial.

We have information about rituximab and bendamustine 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

Professor Paul Moss

Supported by

Johnson and Johnson
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9942

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page