N.B. Principal Investigators, please inform your R&D department of this latest AML16 amendment.
AML 16 Protocol Version 6.1, November 2007
Please note this minor typographical error has been approved by MREC. Please click on the link below to dowload a copy of the MREC acknowledgment letter for this minor amendment.
MREC Approval Letter for typo 17th February 2009
MREC Amendment cover letter 30th January 2009
AML16 Protocol Version 6, Nov 2007 (ATO typo corrected)
N.B. 02/09/08 Professor Burnett has asked that a copy of the AML16 protocol version 6 November 2007 with the ATO typing error corrected be published on the AML16 website. A letter has been sent to MREC informing them of the typing error on 1st September 2008.
MREC Approval Letter for typo 13th October 2008
Patient Information Sheet 1 and Consent Form 1
1st Intensive Randomisation (Version 5 Nov 2007)
Patient Information Sheet 2 and Consent Form 2
Non-Intensive Randomisation (Version 5 Nov 2007)
Patient Information Sheet 3 and Consent Form 3
Storage of Excess Material (Version 4 Nov 2007)
Patient Information Sheet 4 and Consent Form 4
2nd Intensive Randomisation (Version 4 Nov 2007)
Summary of Current Versions of AML16 Trial Documentation
MREC Amendment Covering Letter 14th December 2007
MHRA Amendment Covering Letter 27th December 2007
MREC Notification of Substantial Amendment December 2007
MHRA Notification of Substantial Amendment 27th December 2007
MREC Amendment Approval Letter 31st January 2008
MHRA Amendment Approval Letter 25th February 2008
MHRA Covering Letter 10th June 2008
MHRA Notification of Substantial Amendment 10th June 2008
MHRA Amendment Approval Letter 10th July 2008
Summary of Changes
Summary of Actions Needed
Confirmation of Notification Form
New Randomisation Notepads
Randomisation Notepad, Intensive 1st Randomisation (DA+/-Mylotarg v DClo+/-Mylotarg) Version 3
Randomisation Notepad, Non-Intensive Randomisation (LD Ara-C v LD Ara-C + Mylotarg v LD Clofarabine v LD Ara-C + ATO) Version 5