A trial looking at acute lymphoblastic leukaemia that has not responded to treatment or has come back (Alcantara Study)

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
Leukaemia

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called blinatumomab for people who have acute lymphoblastic leukaemia that has not responded to treatment or has come back after treatment. This study is for people with acute lymphoblastic leukaemia (ALL) that has the Philadelphia chromosome Open a glossary item.

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 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 aims of this trial are to find out how well blinatumomab works for acute lymphoblastic leukaemia that has the Philadelphia chromosome and how safe it is.

Who can enter

You can join this trial if you have pre (precoursor) B cell acute lymphoblastic leukaemia (ALL) that has the Philadelphia chromosome Open a glossary item and you are in one of the following situations

  • You have had at least one of the following drugs dasatinib, nilotinib, bosutinib or ponatinib and your ALL continued to get worse or came back after treatment
  • You are not able to have dasatinib, nilotinib, bostunib or ponatinib
  • You are not able to have imatinib
  • Your ALL continued to get worse while having imatinib

You must also

  • Have more than 5% leukaemia cells in your bone marrow Open a glossary item
  • Have satisfactory blood test results
  • Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Be willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • Be at least 18 years old

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

  • Have ALL in your brain, spine or testicles
  • Have had a transplant using your own stem cells in the past 3 months
  • Are able to have a transplant using your own stem cells
  • Have had chemotherapy in the past 2 weeks apart from an injection of chemotherapy into the fluid around your spinal cord
  • Still have side effects from previous treatment that are moderate to severe, apart from a drop in blood cells
  • 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 moderate to severe symptoms of Graft versus Host Disease (GVHD) or had treatment for GVHD in the past 2 weeks
  • Have had another cancer in the past 5 years apart from non melanoma skin cancer and some early cancers Open a glossary item (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 immunoglobulin
  • Have any other medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 41 people to join.

Everyone 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.

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 your central line. You can walk around as normal. The pump fits into a small bag that you can attach to a belt. You can have up to 5 treatments.

Hospital visits

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

  • A physical examination
  • Blood tests
  • Lumbar puncture
  • Bone marrow test
  • Urine test
  • MRI scan (if needed)
  • CT scan (if needed)
  • Writing test (you will be asked to write a short sentence)
  • Tests of your nervous system
  • Tests to measure your mental wellbeing

At the start of your first treatment you stay in hospital for at least 2 days. At the start of your further treatments you may need to stay in the hospital for 8 hours only. This is to make sure you don’t have a reaction to blinatumomab.

During treatment you see the doctor every 6 weeks for the same tests, apart from the MRI scan.

After treatment you see the doctor every 3 months for 1½ years.

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

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

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

Amgen

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 12069

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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