
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people whose acute myeloid leukaemia (AML) has come back or continued to grow following their first or second treatment.
Chemotherapy is the main treatment for acute myeloid leukaemia (AML). Cytarabine is one of the chemotherapy drugs used.
Cancer cells can switch off an important protein. This protein would normally signal that a faulty cell, such as a cancer cell, should die. When the protein is switched off, the cancer cells continue to multiply.
Idasanutlin is designed to switch this protein back on which means the cancer cells will stop growing and die.
Everyone in this trial has treatment with cytarabine. Some people also have treatment with idasanutlin and some have a dummy tablet (placebo).
The aims of this trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
Other
This is a phase 3 trial. The researchers need 36 people in the UK to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
• One group has cytarabine and idasanutlin
• The other group has cytarabine and a dummy tablet (placebo)
Twice as many people are in the cytarabine and idasanutlin group.
You have idasanutlin or a dummy tablet twice a day. You have a tablet in the morning. Then your second tablet in the evening, about 10 to 14 hours later.
You have cytarabine through a drip into a vein after your morning tablet. This takes between 1 to 3 hours.
You have your tablets twice a day and cytarabine once a day for 5 days. Then you have no treatment for the next 23 days. These are called rest days.
Each period of 28 days (or 3 weeks) is one cycle of treatment.
Your first cycle of treatment aims to get rid of all the leukaemia cells. This is the induction cycle.
Your cancer is in remission if tests show there are no leukaemia cells. You then have 1 or 2 further cycles to stop the AML coming back. These are called consolidation cycles. For consolidation cycles, you have idasanutlin or a dummy tablet once a day (instead of twice a day).
Your doctor might recommend you have a second induction cycle if the treatment has shown some signs of working. But you are not completely in remission.
Your doctor will discuss other treatment options with you if your AML has not responded to induction treatment.
Blood and tissue samples
You have extra blood tests as part of this trial. Where possible these are done at the same time as your routine blood samples. The researchers would also like to collect a sample of your bone marrow whenever this is tested as part of your routine care. For example, when you have a bone marrow aspirate to check for AML.
These blood and bone marrow samples are used to find out what happens to the treatment in your body (pharmacokinetics). And to look for substances called biomarkers to find out why treatment might work for some people and not for others.
The researchers will use some of the samples for genetic research. They want to find more about the role of genes in AML.
Quality of Life
The trial team ask you to fill out a questionnaire before you start treatment and every week while you have treatment. Then every 3 months after you have finished treatment in this trial. The questionnaires ask about side effects and how you are feeling. It looks at your quality of life.
You see the doctors and have some tests before you start treatment. The tests include:
You see a doctor and have blood tests every week during treatment. You have a bone marrow test after each cycle of treatment.
About 4 weeks after your finish treatment you see the doctor again and have some of the same tests as above. You then see a trial doctor every 3 months. They will ask about side effects and about any further treatment you might have had.
If your leukaemia comes back, the researcher would like a sample of any bone marrow tests you have.
As idasanutlin is a new drug, there may be side effects we don’t know about yet. Possible side effects include:
Cytarabine can cause cytarabine syndrome in the first 24 hours following your treatment. Symptoms include:
Your doctor or nurse will give you a contact number to ring if you have any concerns or questions.
Common side effects of cytarabine also include:
Blood tests results might show changes to the way your liver works These liver changes are usually mild and tend not to cause symptoms. These usually go back to normal when treatment is finished. You have regular blood tests to monitor this
We have more information about cytarabine.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Steve Knapper
Roche
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”