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Opting out of drug trial

Hi, i was wondering if anyone has opted out of the Spirit 2 drug trial? I am currently 9 months in to the trial,and dissapointed at my rather slow response to Imatinib. (currently 20% PH+ and 17% PCR) I am wondering whether to ask to come off the trial, and do not know if that would automatically result in me being put on a different drug. When i was first diagnosed the doctor said if i was not in the trial he would have put me on one of the other drugs, but i can't remember which one, as it was all all blur at the time with the shock of diagnosis and i had not read much info on the options. I really wish i was on one of the other drugs now but he has said it is not an option and i am doing fine on Glivec as the target is to get below 35%. I would really appreciate some opinions on this as i have an appointment soon and intend to ask, but don't want to upset the team at the hospital. Thanks

Hello gizmos mum.

If im reading correctly, you have had CML 9 months (Same as me) and have been on the Spirit 2 drug trial since you were diagnosed?
What was your PH+(Cytogenetics) and PCR at the time of diagnosis and what have your trends been like?

Teddy

Hi, I understand why you are tempted to leave the SPIRIT 2 trial. I have looked at the primary endpoint of the trial and that is PFS (progression free survival) at 5 years. However, there is a point that you could use to argue your case.... the Secondary endpoint is: the level of cytogenetic or molecular response at 3 months.

As your current levels is still at 17% bcr/abl at 9 months then you could stress that you are not happy with this rate of response and cite the publication by Marin et al:
A response of less than (<) 10% bcr/abl at 3 months gives an improved chance of progression free survival (PFS) over the longer term (at 8 years I think).

I am not sure that SPIRIT 2 allows cross over.... you need to ask the investigator or your doctor. I think if I had a slow or suboptimal response to IM then I too would ask to either cross over to the dasatinib arm, or leave the trial and request treatment with nilotinib- which is currently the same price as imatinib (IM) and is available as either 1st or second line.
We are waiting to hear whether NICE has given dasatinib a positive recommendation during the review or the drug this month (15th)- the review considered whether dasatinib- as now offered with a PAS - would be cost effective in 1st and 2nd line. We are keeping fingers crossed that NICE will now give the thumbs up.

So if you cannot cross over to dasatinib on SPIRIT 2 (your reason being that you have not had a Complete Cytogenetic Response (2%-1.5%) at 9 months- remember the secondary endpoint of the trial allows for a good response at 3 months-) then you should discuss your options with your doctor. You should not be made guilty for wanting a better response (given all the recently published articles esp. Marin et al) and leaving the trial.

Hope this is helpful- you can find the link to the SPIRIT trials inc. 2 and 3 on the clinical trials page- bottom of main menu. Scroll down to SPIRIT 2 where you will find the outline of the trial. There is a link on there to the SPIRIT Website.

Sandy

Hi Sandy and teddyb

Thank you both for your replies. At the moment i feel a bit fed up with it, I will discuss at my next appointment as Sandy sugggests but I think I will have to wait for the year before i can change treatment unfortunately. Will keep you posted on here next month. I just feel I am being left behind others who are doing so much better and its hard sometimes to try and stay positive, and accept that I am just one of the slow responders!