A trial looking at blinatumomab for acute lymphoblastic leukaemia that has not responded to treatment or has come back after treatment

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers




Phase 2

This trial looked at a drug called blinatumomab for people with acute lymphoblastic leukaemia (ALL). It was for people whose leukaemia hadn’t responded to treatment or it had come back after treatment.

More about this trial

Doctors usually treat acute lymphoblastic leukaemia (ALL) with different chemotherapy drugs. Unfortunately, for some people, these may not work and the ALL continues to grow or comes back after treatment. In this trial, doctors wanted to find out if a drug called blinatumomab could help people in this situation.

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 aims of this trial were to

  • Find out how well blinatumomab works for acute lymphoblastic leukaemia
  • Learn more about the side effects

Summary of results

The trial team found that blinatumomab helped some people with acute lymphoblastic leukaemia that hadn’t responded to treatment or had come back.

189 people took part. Everyone had blinatumomab through a central line (a central venous catheter) into a vein in the chest. They had it through a pump. The pump gave a continuous dose of blinatumomab.

After 2 cycles of treatment, the researchers looked at how well blinatumomab had worked. They found that

  • The leukaemia had completely disappeared in 63 people (they were in remission Open a glossary item)
  • The leukaemia had disappeared in 18 people but blood tests showed levels of blood cells called platelets Open a glossary item and white blood cells Open a glossary item were not back to normal
  • The treatment didn’t work for 90 people
  • They didn’t have the results for 18 people

Of the 81 people whose leukaemia had disappeared, 32 people (40%) went on to have a stem cell transplant.

The researchers followed up the people whose leukaemia had disappeared.  After an average of about 9 months, just over 4 out of 10 people (45%) remained in remission.

The most common side effects of blinatumomab were

  • High temperature (fever) due to a drop in the number of white blood cells
  • A drop in red blood cells Open a glossary item
  • Problems with the central nervous system Open a glossary item such as tremors, dizziness or confusion

The trial team found that blinatumomab helped some people with acute lymphoblastic leukaemia. They suggest that future research looks at having blinatumomab treatment earlier or in combination with other treatments.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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 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 9153

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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