A trial looking at different ways of giving imatinib to people with CML (GIMI)
Cancer type:
Status:
Phase:
This trial looked at whether varying how imatinib (Glivec) is taken, or adding a drug called G-CSF, improves treatment outcome for chronic myeloid leukaemia (CML).
Most people with chronic myeloid leukaemia have an abnormal 
called the Philadelphia chromosome. This is called Philadelphia positive CML.
Doctors usually treat people with Philadelphia positive CML with a biological therapy called imatinib. But although many people respond well to imatinib, they may have a small number of CML cells left in their body after treatment. These cells are sometimes described as ‘sleeping’ CML cells.
Doctors hoped that by giving imatinib in a different way, or in combination with a growth factor called G-CSF, they may be able to kill the remaining CML cells.
The aims of this trial were to find out
- How well imatinib works when it is given in a different way and with G-CSF
- More about the side effects of giving imatinib and G-CSF together
Summary of results
The research team found that adding G-CSF and giving imatinib in a different way was safe, but not helpful for people with CML.
This trial recruited 45 people into 1 of 3 groups. They had all had some treatment already.
- Group 1 had imatinib for 21 days out of every 28, and G-CSF on days 24, 26 and 28
- Group 2 had imatinib for 21 days out of every 28, but no G-CSF
- Group 3 had imatinib every day (continuous treatment) and no G-CSF
Group 3 was the control group, as continuous imatinib was the standard treatment.
The main aim of this trial was to find out more about the side effects of giving treatment this way, and to find out if it was safe.
The people who had G-CSF in group 1 had more bone pain than the people in groups 2 and 3. But there were no other differences in side effects between the groups. And no other side effects related to the trial treatment.
The research team also looked at how well the treatment worked. They found that within a year the treatment stopped working for
- 6 out of 30 people (20%) in groups 1 and 2
- 1 out of 15 people (nearly 7%) in group 3
Although there was a difference between the trial treatments and the standard treatment, it was not big enough to be significant in statistical terms.
This was a small trial, so it is difficult to draw any firm conclusions. However, the results suggest that giving imatinib intermittently and adding G-CSF is not helpful for people with CML.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Tessa Holyoake
Supported by
Bloodwise
Chugai Pharma France
Chugai Pharmaceutical Co Ltd
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
North Glasgow University Hospitals NHS Trust
Novartis Pharmaceuticals UK
University of Glasgow
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
