A trial looking at blinatumomab for people with acute lymphoblastic leukaemia (ALL)

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

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers




Phase 2

This trial is looking at a new drug called blinatumomab for people who have pre B cell acute lymphoblastic leukaemia (ALL).

Doctors usually treat ALL with different chemotherapy drugs.

When you finish chemotherapy you have tests to see how it has worked. Although these may show that your ALL has gone away (in remission Open a glossary item), it may start to grow again. Blinatumomab is a new drug that doctors hope will stop ALL from starting to grow again.

Blinatumomab is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cells’ surface.

The aim of this study is to find out if blinatumomab can help stop or slow down the growth of ALL.

Who can enter

You may be able to enter this trial if you

  • Have pre B cell acute lymphoblastic leukaemia that has gone away but some cells remain in your bone marrow (MRD)
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are willing to use reliable contraception during the study and for 3 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

  • Have any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer
  • Have any medical illness that is a cause for concern
  • Have or have had autoimmune disease Open a glossary item
  • Have had a stem cell transplant using donor cells in the past
  • Have had a stem cell transplant using your own cells in the last 6 weeks
  • Have had treatment with monoclonal antibodies eg rituximab and alemtuzumab in the last 4 weeks
  • Have had any treatment in a trial in the last 4 weeks
  • Know you are allergic to blinatumomab or immunoglobulin
  • Have had chemotherapy in the last 2 weeks
  • Have had radiotherapy in the last 4 weeks
  • Have HIV, hepatitis B or hepatitis C
  • Are pregnant or breastfeeding

Trial design

The trial will recruit 100 people from around the world.

Everybody on the trial will have blinatumomab. You have it through a central line (a central venous catheter) into a vein in your chest for 4 weeks out of every 6. Each 6 week period is called a cycle of treatment.

You have blinatumomab through a pump. The pump gives you a continuous dose of blinatumomab over 4 weeks. You go home with the pump attached to you and can walk around as normal. The pump fits into a small bag that you can attach to a belt. You have up to 4 cycles of treatment.

You fill out a questionnaire before you start treatment and once during every cycle. Then you fill one out again a month after your treatment has finished and then every 3 months for a year. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

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

You have these tests repeated frequently while you are on the study.

Each time you have treatment you stay in hospital. This will be for 3 days for your first treatment and then for 2 days each time you have treatment after that. The pump will need changing twice a week. You can go to the hospital or a nurse may come to your home to change it.

You see the trial doctors a month after you finish treatment and then every 3 months for 2 years. The research team will then contact you every 6 months to see how you are.

Side effects

As blinatumomab is a new drug, there may be side effects we don’t know about yet. Possible side effects include

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 Adele Fielding

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8795

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:

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