The new design will become available on 1st August 2010, with the sapacitabine option being available dependent on the supply being in place.
Only sites which provide the following to the Trials Office in Cardiff will be able to randomise to AML16 from August 1st:
- Evidence of local R&D approval
- A signed, amended site agreement
Protocol Version 7 - At present it is not possible for us to place this document on the trial website - please contact Ian Thomas in Cardiff (tel: 02920 745397, e-mail: thomasif@cf.ac.uk) to request a copy.
AML16_PIS 1_v7_Mar_2010
AML16_PIS_V7_Mar_2010 - At present it is not possible for us to place this document on the trial website - please contact Ian as above
GP Letter Int v2 Mar10
GP Letter NonInt v3 Mar 10
MHRA Approval Letter
MHRA Cover Letter
REC Approval
AML16 Summary of changes