A trial looking at imatinib and dasatinib for newly diagnosed chronic myeloid leukaemia (SPIRIT 2)

This trial is comparing 2 drugs called imatinib and dasatinib for chronic myeloid leukaemia that has been recently diagnosed in chronic phase.

Doctors usually use imatinib (also called Glivec) to treat chronic myeloid leukaemia (CML) when it is in chronic phase. Imatinib is a type of biological therapy called a tyrosine kinase inhibitor or TKI. Most people respond well to this treatment and their CML stays under control for many years.

A new drug called dasatinib (also called Sprycel) can help people who have developed resistance to imatinib, or who cannot take it because of side effects. Dasatinib is also a tyrosine kinase inhibitor.

In this trial, the researchers want to compare dasatinib with imatinib as a first line treatment for chronic phase CML.

The aims of the trial are to

Find out if dasatinib is better than imatinib for people with newly diagnosed CML
Learn more about the side effects

Recruitment

Start 07/08/2008

End 31/12/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with CML in the last 3 months
Have CML which is Philadelphia chromosome positive and is in the chronic phase
Have satisfactory blood test results
Are well enough to take part in the trial (performance status 0, 1 or 2)
Are willing to use reliable contraception during the trial and for 12 months afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years of age

You cannot enter this trial if you

Have already had treatment for CML other than the drugs hydroxycarbamide or anagrelide
Have CML that has spread from your bone marrow to other organs in the body
Have had any other cancer in the last 5 years apart from basal cell skin cancer or carcinoma in situ of the cervix
Have another serious medical condition that cannot be controlled with medication
Have had major surgery in the last 4 weeks or have not recovered from earlier surgery
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

The trial will recruit about 800 people who have recently been diagnosed with CML. 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. There are 2 groups in this trial.

People in group A will have imatinib tablets once a day.

People in group B will have dasatinib tablets once a day.

The trial will last for 5 years, but you will probably need to carry on having treatment indefinitely.

You fill in a questionnaire before you start treatment, every month for the first 3 months, then after 6 months and then once a year until 5 years from joining the trial.

The questionnaire will ask how you are feeling and about any side effects you have had. This is called a quality of life study.