"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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
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.
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
- 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
- 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(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
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.
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.
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
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- A change to the way your liver works
- Feeling or being sick
- Flu like symptoms
- Fluid retention causing swelling
- Itching, skin rash
- Reddening (flushing) of the skin
- Difficulty breathing
- Confusion and feeling agitated
- Difficulty speaking and understanding words
- Difficulty writing
- Difficulty walking
- Loss of memory
- Fitting (seizures)
- Pain in the back, chest or muscles
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
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.
Dr Adele Fielding