Trial Documentation For Download
AML Protocol
New (updated January 2013)
- WCTU Covering Letter dated 28 Nov 2012
- Notification of Sub Amendment - Version 8.0
- MREC Approval Letter - Version 8.0 dated 14 Dec 2012
- MHRA Approval Letter - Version 8.0 dated 7 Jan 2013
- Summary of Changes - Version 7.2 to Version 8.0
- Notification of the Release of AML17 Protocol Version 8.0
- monitor vs no monitor QOL - 3 month
- monitor vs no monitor QOL - 6 month
- monitor vs no monitor QOL - 12 month
Version 7.1, 7.2
- AML17 Protocol version 7.2 (June 2012)
- WCTU Covering Letter dated 5 December 2011
- MREC Approval Letter date 14 December 2011
- MREC Approval Letter GP 1 dated 24 October 2011
- MREC Approval Letter dated 06 June 2012
- WCTU Covering Letter dated 01 June 2012
- MREC Notification of Substantial Amendment
Versions 6.0, 7.0 amendment, August 2011
Patient Information Sheets & Consent Forms - Updated August 2011
N.B. These are editable Word documents approved by MREC. No text in the documents must be altered. Please use the Word documents to enter your local contact details as appropriate and insert on your local headed paper.
- Patient Information Sheet 1 (v7.0 Nov 2012)
- Patient Information Sheet 2 (v6.0 Nov 2012)
- Patient Information Sheet 3
- Patient Information Sheet 3a v1.0 Feb 2011
- Patient Information Sheet 4
- Patient Information Sheet 5
- Patient Information Sheet 6
- Patient Information Sheet 7
- Patient Information Sheet 8
- Patient Information Sheet 9
- 1A Induction info consent parent 13-15
- 1A Info 0-8 years
- 1A Info patients-13-15
- 1A Information over 16
- 1A Parent Info consent 0-8
- 1A Parent Info consent 8-12
- 1A Patients 8-12
- 2A Induction 0-8 patient
- 2A Induction info and consent-parent 0-8
- 2A Induction info and consent-parent 8-12
- 2A Induction info and consent-parent 13-15
- 2A Induction over 16
- 2A Induction-patient 13-15
- 2A Patient induction 8-12
- 4 Patient information Sheet 0-7
- 4 Parent information Sheet 0-7
- 4 Patient Information Sheet 8-12
- 4 Parent Information Sheet 8-12
- 4 Patient Information Sheet 13-15
- 4 Parent Information Sheet 13-15
- 7A Consolidation 8-12*
- 7A Consolidation patient 0-8*
- 7A Consolidation_over16*
- 7A Parent consolidation 0-8*
- 7A Parent consolidation 13-15*
- 7A Parent consolidation 8-12*
- 7A Patient 13-15*
- 8 Patient Information Sheet 0-7
- 8 Parent Information Sheet 0-8
- 8 Patient Information Sheet 8-12
- 8 Parent Information Sheet 8-12
- 8 Patient Information Sheet 13-15
- 8 Parent Information Sheet 13-15
- 9 Patient Information Sheet 0-7
- 9 Parent Information Sheet 0-7
- 9 Patient Information Sheet 8-12
- 9 Parent Information Sheet 8-12
- 9 Patient Information Sheet 13-15
- 9 Parent Information Sheet 13-15
GP Letters
N.B. These are editable Word documents approved by MREC. No text in the documents must be altered. Please use the Word documents to enter your local contact details as appropriate and insert on your local headed paper.
- GP Letter 1 Version 2
- GP Letter 2
- GP Letter 3
- GP Letter 4
- GP Letter 5
- GP Letter 6
- GP Letter 6a
- PAED GP letter induction
- PAED GP letter consolidation
- PAED GP letter FLT 3
Ethics & Other Documentation
- MREC Amendment Approval Letter 17 July 2009 (additional information)
- Response from Prof-Burnett dated 21 July 2009
- AML17 A Form
- AML17 Cytogenetic Form
- NRES application
- AML Serious Adverse Event Report Form Version 2.0
- Notification of approval from Wales REC*
- Clinical Trials Authorisation
- Letter from Sponsor (Cardiff University)
- Latest letter from ethics to be updated
- Statement on Excess Treatment Costs
- APL Sample Flow Chart (PDF)
- AML17 Advice on Gemtuzumab Ozogamicin (Mylotarg) (PDF)
- AML 17 Sample Flow
- AML 17 Section B Form
- AML 17 CEP70 Assessment Form
- AML 17 mTOR Assessment Form
Pharmacist's Section
- AML 17 Clofarabine Request Form
- AML 17 mTOR Assessment Form
- AML 17 Everolimus Request Form
- Arsenic Trioxide Request Form
- CEP 701 Drug Accountability Form
- Mylotarg Request Form #Updated to v2
- CEP-701 Request Form #Updated to v4.2
- AML17 Stability Storage Information*
- CEP70/Placebo Accountability Form
- NCRI-AML17 Trial Clofarabine Accountability
- NCRI-AML17 Trial Mylotarg Accountability
- Rad001 Accountability Form
- Trisenox Drug Accountability
- AML 17 Clofarabine Request Form
- AML 17 Everolimus Request Form
* Not available on website, contact Trials Office for information
