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AML 16

There will be a central shutdown of IT systems on Tuesday 10th and Wednesday 11th April.  Network connectivity will be unavailable and as a consequence there will be online no access to any of the trial databases during this time.

For recruiting trials we will be maintaining a paper-based randomisation service during the hours of 9am – 5pm during this period – for this call 0800 953 0274. Randomisations out with this time will be unavailable.  We apologise for the inconvenience this may cause but these circumstances are out with our control.


National Cancer Research Institute Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome Trial 16

Please use the buttons at the top, or the menu on the left to navigate our site and find out more about the AML16 trial.

Latest News!

As communicated to Principal Investigators and research nurses at the start of October 2011, the sapacitabine option in the non-intensive arm is now available to all participating sites.  Details of the delivery of this treatment have been clarified in protocol version 7.1.

The maintenance option in the intensive arm reached its target accrual in September 2011.  The option remains open to patients who entered the trial prior to 05 September 2011; patients entering the trial after this date will not be eligible for maintenance randomisation.  The consolidation randomisation (2v3 courses) will remain open to all patients until trial closure, expected in early 2012.

For information on the options available to your site, and individual patients, or a copy of the current approved protocol please contact Angela Grech (grecha2@cardiff.ac.uk) or Ian Thomas (thomasif@cardiff.ac.uk) on 02920 745397.

If your site has already joined AML16, your Principal Investigator will have received the necessary documents to obtain R&D approval for this protocol.  Should your R&D department require further documentation, please contact Ian Thomas at the Trials Office in Cardiff (tel: 02920 745397, thomasif@cf.ac.uk).

A summary of previous AML16 amendments can be accessed by clicking on the link below:

OverallAML16AmendmentSummary

Should you require further information relating to these amendments for your site file, contact Ian.

Click here to access randomisation notepads

AML16 randomisation option notes

Trial Drugs

Click here for information on how your centre can join AML16

Randomisation

If you wish to enter a patient into the AML16 trial please use the online randomisation and data entry system:

 https://www.trials.bham.ac.uk/aml16 or telephone: 0800 953 0274 (Monday - Friday 9.00am - 5.00pm, except Bank Holidays).