VIOLA

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.pdf]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the VIOLA Trial Office.

• Protocol version 5.0 05-Apr-2016 [.pdf]
• Patient Information Sheet version 6.0 04-Feb-2016 [.pdf]
• Informed Consent Form version 6.0 04-Feb-2016 [.pdf]
• GP Letter version 3.0 28-Mar-2014  [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.

• Version Control Checklist - Investigator Site Folder version 6.0 23-Apr-2018 [.pdf]
• Version Control Checklist - Investigator Site Folder version 5.0 10-Oct-2016 [.pdf]
• Version Control Checklist - Investigator Site Folder version 4.0 05-Nov-15 [.pdf]
• Version Control Checklist - Investigator Site Folder version 3.0 08-Jul-14 [.pdf]
• Version Control Checklist - Investigator Site Folder version 2.0 25-Jun-14 [.pdf]

• Version Control Checklist - Pharmacy Folder version 4.0 19-Sep-14 [.pdf]
• Version Control Checklist - Pharmacy Folder version 3.0 30-May-14 [.pdf]
• Version Control Checklist - Pharmacy Folder version 2.0 22-May-14 [.pdf]
• Version Control Checklist - Pharmacy Folder version 1.0 10-Mar-14 [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

Amendment 01 [opens new page]
Amendment 02 [opens new page]
Amendment 03 [opens new page]
Amendment 04 [opens new page]
Amendment 05 - Addition of new site only
Amendment 06 - Update to Reference Safety Information only

Case Report Forms

• Registration Form [.pdf]
• Eligibility Form [.pdf]
• Baseline Form [.pdf]
• AML Disease History Form [.pdf]
• MDS Disease History Form [.pdf]
• Treatment Cycle 1 Form [.pdf]
• Treatment Cycle 2-6 Form [.pdf]
• Subsequent Cycle Form [.pdf]
• 28 Days from End of Treatment Form [.pdf]
• 1 Year from End of Treatment Form [.pdf]
• Adverse Event Form [.pdf]
• Acute GvHD Form [.pdf]
• Chronic GvHD Form [.pdf]
• Immunosuppressant Concomitant Medication Form [.pdf]
• Treatment Discontinuation Form [.pdf]
• Withdrawal Form [.pdf]
• Deviation Form [.pdf]
• Death Form [.pdf]
• SAE Form [.pdf]
• Pregnancy Notification Form [.pdf]

Guidelines

• Sample Collection Guidelines  [.pdf]
• SAE Form Completion Guidelines  [.doc]

Other Trial Documents

• Pharmacy Manual [.pdf]
• SAE Fax Cover Sheet [.pdf]
• SmPCs
  • Azacitidine SmPC [.pdf]
  • Lenalidomide SmPC [.pdf]

Craddock C, Slade D, De Santo C, Wheat R, Ferguson P, Hodgkinson A, Brock K, Cavenagh J, Ingram W, Dennis M, Malladi R, Siddique S, Mussai F, and Yap C. Combination Lenalidomide and Azacitidine: A Novel Salvage Therapy in Patients Who Relapse After Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia. J Clin Oncol 37:580-588.

None at present

Chief Investigator

Professor Charles Craddock
Consultant Haematologist
Centre for Clinical Haematology
Queen Elizabeth Hospital Birmingham
Edgbaston
Birmingham
B15 2TH

Tel: 0121 371 4374
Email: Charles.Craddock@uhb.nhs.uk

Tel:      +44 (0)121 371 4365
Fax:     +44 (0)121 371 7874
Email: VIOLA@trials.bham.ac.uk

VIOLA Trial Office
Trial Coordinator: Mohamed Elhaneid                         
Trial Management Team Leader: Shamyla Siddique  
Trial Statistician: Daniel Slade                         

Centre for Clinical Haematology
Research Office
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Enquiries
Telephone: +44 (0)121 371 4365
Fax:             +44 (0)121 371 7874
Email:         VIOLA@trials.bham.ac.uk

Trial Entry
VIOLA is closed to recruitment

Serious Adverse Event Reporting
Fax: +44 (0)121 371 7874

Sponsor

University of Birmingham

Correspondence to:
Centre for Clinical Haematology
Research Office
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH