
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at new drugs in combination with cytarabine (Ara C) for acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS).
Doctors often treat acute myeloid leukaemia (AML) and high risk MDS with intensive chemotherapy to try and get rid of it. But some people can’t or don’t want to have intensive chemotherapy. For these people doctors may use the chemotherapy drug cytarabine at a lower dose than in intensive chemotherapy. They know cytarabine works but are always looking for new treatments.
In this trial some people will have cytarabine and others will have cytarabine in combination with newer drugs. The researchers will compare the groups to find out which is best for treating people with AML and high risk MDS.
You may be able to enter this trial if you
You cannot enter this trial if you
You can't have BCT-100 if you have had another drug that works in a similar way. But you may still be able to take part in this trial and have one of the other drugs.
This is a phase 2/3 trial. It will recruit 1,000 people.
It is a randomised trial. You are put into a treatment group by a computer. Neither you nor your doctor can choose which group you are in. The groups are:
Please note: People are no longer been put into the following treatment groups:
Not all of the treatment groups will be available at every centre, all of the time. Your doctor will tell you which ones are available to you.
The treatments repeat every 4 to 6 weeks, depending on the treatment you are having and how your AML responds to treatment. Each 4 to 6 week period is called a cycle of treatment.
You have cytarabine as an injection under the skin. You have it twice a day for 10 days every 4 to 6 weeks. You may be able to have this at home. You can talk to your doctor about this.
You have BCT-100 as a drip into a vein (intravenous). You have it once a week for 4 weeks at the start of each cycle of treatemnt.
You have at least 4 cycles of treatment. You may continue having treatment as long as it is helping you.
You fill in a questionnaire before starting treatment and at 3, 6 and 12 months. It will ask about how you have been and any side effects you have. This is called a quality of life study.
The researchers will also ask your permission to store blood and bone marrow samples. They will take the blood samples when you have your routine samples taken. And the bone marrow samples from when you had your bone marrow test done. These samples will be used in future to find out more about AML. You don’t have to agree to these if you don’t want to. You can still take part in the main trial.
The researchers may also ask for additional blood samples if you are having BCT-100. This is to find out more about the how the drug is working.
You will see the doctor and have some tests before starting treatment. These may include
When you start treatment you continue to have blood tests.
The most common side effects of the drugs used in this trial are
We have more information on cytarabine in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mike Dennis
Bloodwise
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”