CEP-701 Forms
Patient Information Sheet 2b, Version 06/07/2007
Consent Form 2b, Version 1, March 2006
CEP-701 14 Day Assessment Form
CEP-701 Drug Accountability Form
CEP-701 Subsequent Course Order Form
When a patient is randomised to receive CEP-701 Cardiff will arrange for a supply of CEP-701 to be delivered to the centre's pharmacy department.
2 bottles will be provided to the patient/caregiver for each treatment course
Centres should use the CEP-701 Subsequent Course Order Form above to order CEP-701 supplies for Courses 2, 3 and 4.
FLT3 Laboratories
AML15 Centres and Designated FLT3 Analysis Laboratories
FLT3 and CEP-701 Information
Picture of CEP-701 consumables and 100ml bottle
Urgent Update Newsletter November 2006
CEP-701 Investigator's Brochure - A copy of this must be added to your Site File. Please contact the AML Trials office if you require a copy
MHRA Amendment Approval of CEP-701 packaging change (Feb 2007)
CEP-701 Request for Substantial Amendment Letter 18.12.06
MHRA Amendment Approval Letter 13.02.07 (please contact Trials Unit for pdf)
Notes
Samples for FLT3 mutation analysis are sent to the London or Cardiff reference laboratories by participating AML15 centres. (Please see list above for which laboratory is designated to your centre)
When the FLT3 mutation analysis has been performed the Randomising Consultant will receive an email stating whether the patient is either 'FLT3 Mutant', 'FLT3 Wild Type' or 'FLT3 Analysis Failed'
If the patient is 'FLT3 Mutant' the email will invite the Randomising Consultant to enter the patient into the CEP-701 randomisation
Only patients who have a confirmed FLT3 mutation are eligible to enter the CEP-701 randomisation
The CEP-701 randomisation will only take place in non-APL patients aged over 15 yrs old
The CEP-701 randomisation will only take place in UK AML15 centres who have acknowledged receipt of the AML15 Version 5 March 2006 amendment
Patient Information Sheet 2B and Consent Form 2B should be used
Patients should be randomised immediately following the end of the 1st course of chemotherapy so as the treatment can start 2 days after the completion of the allocated chemotherapy
If randomised to CEP-701 patients should commence 2 days after the completion of each course (1-4) of chemotherapy and should continue until 2 days before the commencement of the next chemotherapy course, or for a maximum of 28 days after the end of the chemotherapy course, whichever is sooner
Treatment with CEP-701 must stop 2 days before the first administration of the next course of chemotherapy because elevated CEP-701 plasma concentrations may interfere with the effect of chemotherapy
CEP-701 must not be administered concurrently with other chemotherapy
Mylotarg in consolidation will be evaluated in patients who do not enter the CEP-701 randomisation
No patient will receive CEP-701 treatment after course 5
It is expected that CEP-701 will be administered at home and investigators must ensure that the patient has received adequate instruction in preparing the drug. An instruction sheet is given above which supersedes the instructions given in Appendix D of the AML15 protocol Version 5 March 2006. The instruction in the Protocol appendix will be amended in due course
CEP-701 syringes now comply with the necessary regulations. The new dispenser (or syringe) cannot fit onto intravenous needles
Blood samples (20ml) and some information about compliance, azole treatment and tolerability will be requested on day 14 of CEP-701 treatment after each course. Sites will automatically be contacted about that, and the necessary sample bottles will be supplied to the site as part of the initial sample kit
For full details please refer to the current AML15 Protocol
Information from Professor Burnett from August 2007 Newsletter FLT-3 Inhibitor (CEP-701) Treatment
Some patients are finding CEP-701 is difficult to take because of nausea or other GI symptoms. Interestingly this is mostly restricted to patients who are at the same time receiving Azole antifungal prophylaxis. This is not unexpected as Azole treatment can result in high CEP-701 blood levels. If Azole treatment or prophylaxis is going to be given patients should start on a 40mg dose level and gradually increase if possible. It is important that the day 14 samples for measurement of activity continue to be sent to Cardiff, and that patients receive effective anti-emetic prophylaxis.
