Download patient information sheet 6

AML 17 TRIAL: PATIENT INFORMATION SHEET 6
(Ref: ISRCTN55675535)
Randomisation to mTOR Inhibitor
Introduction
You have already agreed to enter this trial and have completed your first course of
chemotherapy. You will now go on to receive course two as planned which will be the same
chemotherapy combination (DA OR ADE) but without the Mylotarg. Some information is
now available which means that you are eligible for an additional treatment option which we
wish to evaluate within the trial.
What makes leukaemic cells different from normal cells is that some of the chemical signals
inside the cells don’t work properly and are continuously telling the cell to grow or not to die
when it should. These chemical signals are organised into pathways and one of these
pathways involves a protein chemical called mTOR. There is some indication that this may
be active in leukaemia cells, but not in normal cells.
After the next and subsequent courses of chemotherapy we wish to test the addition of a
new drug which can turn off, or inhibit, the protein mTOR. This is called Everolimus, or
RAD001. This has been successful in other cancers for example kidney cancer, where the
same pathway as in leukaemia cells may be involved in kidney cells. We know from that
experience that the drug is well tolerated when given by mouth or intravenous infusion. We
also know that it is well tolerated when combined with the chemotherapy given for
leukaemia although the number of patients who have received it so far is quite small. It has
also been given with several other chemotherapy drugs used in other cancers.
Patient Information and Consent form 6,
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In the AML17 trial patients will be allocated at random to receive or not to receive the drug
Everolimus in tablet form each day for up to 28 days after each course of chemotherapy for
a total of three courses. The treatment will start after you have finished each course of
chemotherapy and will continue for 28 days, or until it is decided to give you the next course
of chemotherapy, whichever is the shorter.
So what is being tested is standard treatment versus standard treatment with Everolimus
(RAD001).
Why are we doing this study?
We wish to find out whether giving you treatment with this mTOR inhibitor (EverolimusRAD001) in addition to chemotherapy reduces the risk of future relapse.
What will happen?
If you agree, you will be allocated by computer to receive the Everolimus or not. The
treatment is given in tablet form to be taken each day for up to 28 days for a total of three
courses. Two out of every three patients entering this part of the study will be allocated
Everolimus.
This treatment is well tolerated and is not usually associated with nausea which you might
have experienced with chemotherapy. Your medical team will be keeping a close eye on
you to look out for any other side effects. In the unlikely event of you having unexpected
side-effects a decision will be taken either to reduce the dose of Everolimus in subsequent
treatments or to stop it altogether.
.At the beginning of Everolimus treatment and after about 14 days of each course of the
drug, you will be asked to give a blood sample which will be used to find out whether blood
levels of Everolimus are adequate. On that day you should delay taking your dose until after
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the blood sample has been taken. In addition it is possible that the fat and sugar levels in
your blood may rise, but your doctor will test for that.
Will you have side effects?
There is a small chance that your appetite will be reduced and you may experience some
mild stomach symptoms such as nausea which can be treated with anti-sickness
medication if required. Your doctor will also check your blood chemistry because in some
patients the lipid and glucose content of the blood may increase, but you will not feel these
effects.
Will you benefit from the treatment?
We do not know if using this drug will improve the outcome, so if you are allocated to it you
are not guaranteed to benefit.
What are the alternatives?
The mTor inhibitor (Temsirolimus-RAD001) is not available outside the trial for treating
leukaemia because it has not received a licence to be used outside trials.
Can I withdraw from the trial?
You do not have to enter this randomisation. You are also free to withdraw from the
Everolimus (RAD001) treatment at any time. If you wish to do so you can continue in the
AML17 trial and enter the next part of the trial if you wish to do so.
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Contact for Further Information
Further information can be obtained from your local organiser (Principal Investigator) or the UK
organiser (Chief Investigator) whose addresses are given below.
Chief Investigator:
Prof Alan Burnett
Department of Haematology
University Hospital of Wales
Cardiff
CF14 4XW
Tel: 029 2074 2375
e-mail: [email protected]
Thank you for considering participation in this part of the Trial.
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WRITTEN CONSENT FORM 6
FOR
Acute Myeloid Leukaemia 17 Trial
(Trial Reference ISRCTN55675535)
Randomisation to mTOR Inhibitor
(Please initial)
1.
I have read the attached Information Sheet version 5 dated October 2008
2.
I have had an opportunity to discuss this study and ask questions
3.
I have received satisfactory answers to all of my questions
4.
I have received enough information about the study
5.
I have spoken with Dr./ Mr./ Ms.____________________________
6.
I understand that I am free to withdraw from the study:

at any time

without having to give reasons

without affecting my future medical care
7. I understand that sections of my medical records relating to my participation in the study
may be inspected by responsible individuals from the trial Sponsor who is Cardiff University.
All personal details will be treated as STRICTLY CONFIDENTIAL. The information will be
used for medical research only and I will be identified only by trial number, initials and date
of birth. I will not be identified in any way in analysis and reporting of the results.
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I give permission for these individuals to have access to my records and to have my clinical
details recorded in this way
8.
I agree to participate in this study
9.
I give permission to tell my GP about my participation in the study
Patient’s Signature:_____________________________________
Name in block letters:___________________________________
Date_____________________
Doctor’s Signature:_____________________________________
Name in block letters:___________________________________
Date_____________________
Patient Representative’s Signature:
(if appropriate)_________________________________________
Name in block letters:___________________________________
Relationship to patient: __________________________________
Date_____________________
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