"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of vosaroxin with cytarabine for acute myeloid leukaemia (VALOR)
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 vosaroxin in combination with cytarabine to treat acute myeloid leukaemia (AML) that has not responded to treatment or has come back after the first treatment.
Vosaroxin is a new chemotherapy drug. Doctors want to find out if vosaroxin and cytarabine are better at treating AML than cytarabine alone.
The aims of the trial are to
- Find out if vosaroxin and cytarabine together is better at treating AML that has not responded to treatment or has come back after the first treatment than cytarabine alone
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have acute myeloid leukaemia (AML) that has not responded to treatment or has come back after your first treatment
- Are well enough to be up and about for at least half the day (performance status 0, 1, or 2)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the study and for 30 days afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have a type of AML called acute promyelocytic leukaemia (APL)
- Have AML in your brain or spinal cord (
central nervous system)
- Have had more than 2 cycles of chemotherapy to try to get rid of AML (induction chemotherapy)
- Have had cytarabine in the last 3 months
- Have had treatment with hydroxyurea in the last 24 hours
- Have had vosaroxin before
- Have had treatment as part of another trial the last 2 weeks
- Have had a bone marrow or stem cell transplant in the last 3 months
- Have had drugs to dampen down your
immune systemin the last 2 weeks
- Need kidney dialysis
- Are known to be HIV positive
- Have an infection that cannot be controlled with medication
- Have heart problems that are a cause for concern
- Are still having side effects from earlier treatment, unless they are very mild
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least a year ago
- Are pregnant or breastfeeding
This trial will recruit about 675 people from around the world. 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 either. This is called a double blind trial.
You have treatment every 2 to 8 weeks, this is called a cycle of treatment. The length of a treatment cycle depends on how quickly you recover from any side effects.
People in group 1 have cytarabine on days 1 to 5, and vosaroxin on day 1 and day 4 of each cycle. You have both drugs through a drip into a vein.
People in group 2 have cytarabine on days 1 to 5 and a dummy drug (
You may have up to 4 cycles of treatment.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine tests
- Bone marrow test
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
During your treatment you see the doctors frequently. You have regular blood, urine and bone marrow tests.
When you finish the treatment, the research team will contact you or your doctor to find out how you are
- Every month for a year
- Every 2 months for the next year
- Then every 3 months
The most common side effects of vosaroxin and cytarabine are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Tiredness (fatigue)
- Hair loss
- Feeling or being sick
- Sore mouth
- A decrease in appetite
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 Jonathan Kell
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sunesis Pharmaceuticals Inc