FIGARO

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 and 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 etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the Figaro Trial Office.

• Protocol version 8.0 [.pdf]
• Patient Information Sheet version 7.0 [.pdf]
• Informed Consent Form version 4.0 [.pdf]
• GP Letter version 3.0 [.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 File v5.0 [.pdf]
• Version Control Checklist - Pharmacy Folder v2.0 [.pdf]

Amendments

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 [opens new page]
• Amendment 06 [opens new page]
• Amendment 07 [opens new page]

Case Report Forms

Current Case Report Forms:

• Eligibility Form [.pdf]
• Randomisation Form [.pdf]
• Disease History – AML Form [.pdf]
• Disease History – MDS Form [.pdf]
• Pre-transplant Form [.pdf]
• Transplant Form [.pdf]
• FBA Control Arm Treatment Form [.pdf]
• FB-ATG Control Arm Treatment Form [.pdf]
• FMA Control Arm Treatment Form [.pdf]
• FLAMSA-BU Arm Treatment Form [.pdf]
• Follow-up Form [.pdf]
• Acute GvHD Form [.pdf]
• Chronic GvHD Form [.pdf]
• Donor lymphocyte infusion Form [.pdf]
• Relapse Form [.pdf]
• Death Form [.pdf]
• Trial Discontinuation Form [.pdf]
• Withdrawal of consent Form [.pdf]
• Adverse Event Form [.pdf]

• Serious Adverse Event Form [.pdf]
• SAE Fax Cover Sheet [.pdf]

Guidelines

• CRF Completion Guidelines  [.doc]
• SAE Form Completion Guidelines  [.doc]
• Sample guidelines and calculator [.xls]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Quality of Life Questionnaire [.pdf]
• Summary of Product Characteristics
  • Fludarabine SmPC [.pdf]
  • Melphalan SmPC [.pdf]
  • ATG SmPC [.pdf]
  • Cytarabine SmPC [.pdf]

To date there are no publications for this trial.

• Figaro newsletter June 2016 [.pdf]
• Figaro newsletter March 2016 [.pdf]
• Figaro newsletter July 2015 [.pdf]

Chief Investigator

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

Tel: +44 (0)121 371 4374
Fax: +44 (0)121 371 4398
Email: Charles.Craddock@uhb.nhs.uk

FIGARO Trial Office

Trial Coordinator: Andrea Hodgkinson                       
Trial Administrator: John Mason                                 
Trial Management Team Leader: Shamyla Siddique 
Trial Statistician: Aimee Jackson                            

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:         figaro@trials.bham.ac.uk

Trial Entry

FIGARO is now 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