A trial comparing blinatumomab with chemotherapy for acute lymphoblastic leukaemia (TOWER)

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 3

This trial is comparing a drug called blinatumomab with chemotherapy for people who have acute lymphoblastic leukaemia (ALL). It is for people with ALL that has not responded to treatment or has come back after treatment.

Doctors usually treat ALL with different chemotherapy drugs. Unfortunately for some people, these may not work and their ALL continues to grow or comes back after treatment. Blinatumomab (pronounced blin-at-oo-mow-mab) is a new drug that doctors hope will help these people.

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 trial is to find out how well blinatumomab works for acute lymphoblastic leukaemia when compared to chemotherapy.

Who can enter

You can join this trial if

  • You have a type of ALL called pre (precursor) B cell acute lymphoblastic leukaemia
  • Your leukaemia cells do not have a gene change called the Philadelphia chromosome Open a glossary item
  • You have had chemotherapy to treat your ALL
  • Your ALL is not responding to chemotherapy or has come back after treatment
  • You have more than 5% leukaemia cells in your bone marrow Open a glossary item
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have ALL in your brain, spine or testicles
  • Only have ALL outside of your bone marrow
  • Have had a transplant using your own stem cells in the past 6 weeks
  • Have had a transplant using donor stem cells in the past 3 months
  • Have moderate to severe symptoms of graft versus host disease (GVHD)
  • Have had treatment for GVHD in the past 2 weeks
  • Have had chemotherapy in the past 2 weeks apart from an injection of chemotherapy into the fluid around your spinal cord
  • Have had radiotherapy in the last 2 weeks
  • Have had a drug that triggers the immune system, for example rituximab, in the past month
  • Have had an anti CD19 treatment (your doctor can tell you this)
  • Have already had blinatumomab
  • Have or have had epilepsy, a stroke, dementia, Parkinson’s disease or another condition that affects your central nervous system (CNS) Open a glossary item (your doctors can advise you about this)
  • Have been diagnosed with Burkitt’s lymphoma
  • Have or have had an autoimmune disease Open a glossary item
  • Have had another cancer in the past 5 years apart from some early cancers that were successfully treated (the trial team can tell you about this)
  • Are known to have HIV
  • Have tested positive for hepatitis B or hepatitis C
  • Have had an experimental drug as part of a clinical trial in the past month
  • Are allergic to blinatumomab or immune system proteins called immunoglobulins
  • Have any other medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This phase 3 trial is an international study. In total the researchers will need about 400 people to take part. People taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in. This is called randomisation. Of all those joining the trial

  • 2 out of 3 people will have blinatumomab
  • 1 out of 3 people will have standard chemotherapy

12064 Trial Diagram


If you are in the blinatumomab group you have the drug through a line into a vein in your chest (a central line). You have blinatumomab through a pump. The pump gives you a continuous dose of blinatumomab over 4 weeks then you have 2 weeks with no treatment. Each 6 week period is called a cycle of treatment.

After 2 cycles of treatment, your doctors will check to see if the treatment is working. If your doctor thinks the drug is helping you, you have a further 3 cycles of blinatumomab. If the drugs continue to work, you can continue with treatment for another 12 months. During this time your treatment will be over 4 weeks with 8 week breaks between treatments.

If you are in the group having chemotherapy your doctor will choose the best treatment for you. We have information about the most common chemotherapy drugs used to treat ALL.

You will have 2 cycles of chemotherapy. The doctors then check to see if it helping you. If it is you have a further 3 cycles of treatment. Your doctors will then decide if they think you will benefit from more chemotherapy. You could then have treatment for another 12 months.

Treatment with blinatumomab will stop after 2 cycles if

Treatment will also be stopped if

  • Acute lymphoblastic leukaemia (ALL) cells are found outside your bone marrow, for example in your testicles, breasts, brain or spine
  • You decide you don’t want to continue with the trial or
  • Your trial doctor feels its best for you to stop the trial

If you are in the group having chemotherapy your doctors will explain if they need to change your treatment and why.

The trial team will ask people in both groups to fill out a couple of questionnaires before you start treatment and at set times during the trial. The questionnaires will ask about side effects and how you’ve been feeling. One questionnaire is called a quality of life study  and the other is the Acute Lymphoblastic Leukemia Symptom Scale (ALLSS).

Hospital visits

You see the doctor to have some tests before taking part. These tests may include

You have these tests repeated frequently while you are taking part in the trial.

If you are in the blinatumomab group you will be asked to write a short sentence that includes the date, the location of the clinic and the time. You will need to save your written sentences and take them in for every appointment so the doctors can check them and monitor your writing.

If you are having blinatumomab you will stay in hospital for a couple of days for your first treatment. After that you go home with the pump attached to your central line. You can walk around as normal. The pump fits into a small bag that you can attach to a belt. The pump will need changing regularly during treatment. You can go to the hospital, or a nurse may visit you at home to change it.

If you are having chemotherapy you will probably be in hospital for the time you are having your treatment. How long this is for will vary depending on what drugs you are having. You may be in hospital for up to 1 month each time.

When you finish treatment, you will see the trial team again about a month later. After that, they will check how you are every 3 months. This may be at a hospital appointment or they may contact you by phone.

Side effects

Blinatumomab is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

The most common side effects associated with the chemotherapy drugs used for ALL include

We have more information about the drugs used for ALL and their side effects.

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

NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 12064

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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