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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, Version 5, October 2008 1 of 6 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 Patient Information and Consent form 6, Version 5, October 2008 2 of 6 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. Patient Information and Consent form 6, Version 5, October 2008 3 of 6 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. Patient Information and Consent form 6, Version 5, October 2008 4 of 6 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. Patient Information and Consent form 6, Version 5, October 2008 5 of 6 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_____________________ Patient Information and Consent form 6, Version 5, October 2008 6 of 6