PHAZAR

Figure 1: PHAZAR Interventional component actual and target recruitment

 

Figure 2: PHAZAR Observational component actual and target recruitment

Site Name	Principal Investigator	Number of patients recruited
Guy's Hospital, London	Professor Claire Harrison	8
Beatson West of Scotland Cancer Centre, Glasgow	Dr Mark Drummond	5
The Queen Elizabeth Hospital, Birmingham	Dr Fiona Clark	4
University Hospital of Wales, Cardiff	Dr Steven Knapper	4
Southamptom General Hospital	Dr Srivinasan Narayanan	4
Nottingham City Hospital	Dr Jenny Byrne	3
Addenbrooke's Hospital, Cambridge	Dr Anna Godfrey	2
Churchill hospital, Oxford	Professor Adam Mead	2
Hammersmith Hospital, London	Dr Dragana Milojkovic	2
Christie Hospital, Manchester	Dr Tim Somervaille	2
St James's University Hospital, Leeds	Professor David Bowen	2
St Bartholomew's Hospital, London	Professor Jamie Cavenagh	0
University College London Hospital	Dr Mallika Sekhar	0

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 PHAZAR Trial Office.

Protocol

• Protocol v5.0a - Aug-2018 [.pdf]
• PI Protocol Signature Page v5.0a [.pdf]
• Trial Summary [.pdf]

Patient Documents

• Patient Information Sheet - Interventional (v6.0) [.docx]
• Patient Information Sheet - Observational (v4.0) [.docx]
• Patient Information Sheet - Donating Tissue Research [.docx]
• Informed Consent Form - Interventional (v5.0a) [.docx]
• Informed Consent Form - Observational (v4.0) [.docx]
• Informed Consent Form - Donating Tissue Research [.docx]
• GP Letter (v2.0) [.docx]
• Release of Medical Information Form [.docx]
• Patient Cards [.pdf]
• Patient Diary (v2.0) [.pdf]
• Quality of Life Booklet - Interventional patients (v2.0) [.pdf]
• Quality of Life Booklet - Observational patients (v2.0) [.pdf]

• GDPR Nortification vA 18-Jul-2018 [.pdf]
• Patient GDPR Notification Log v1.0 08-Oct-2018 [.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 v8.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v7.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v6.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v5.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v4.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v3.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v2.0 - Investigator Site Folder [.pdf]
• Version Control Checklist v1.0 - Investigator Site Folder [.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.

• Summary of Amendments [.pdf] 
• PHAZAR Amendments  (opens new page)

 Guidelines

• SAE Form Completion Guidelines (v2.0) [.pdf]
• Guidelines for Site Staff on Informed Consent Procedure (v1.0) [.pdf]
• PHAZAR eCRF User Manual (v1.0) [.pdf]
• Sample Collection Guidelines (v2.0) [.pdf]

 

Case Report Forms

Interventional

• Registration Form (v3.0) [.pdf]
• Eligibility Form (v3.0) [.pdf]
• Baseline Form (v2.0) [.pdf]
• Treatment Cycle 1 Form (v2.0a) [.pdf]
• Treatment Cycle 2-6 Form (v2.0a) [.pdf]
• Subsequent Cycle Treatment Form (v2.0a) [.pdf]
• 28 day Follow Up Form (v2.0a) [.pdf]
• 1 Year Follow Up Form (v3.0) [.pdf]
• Adverse Event Form (v3.0) [.pdf]
• Treatment Discontinuation Form  (v3.0) [.pdf]
• Withdrawal Form [.pdf]
• Deviation Form [.pdf]
• Death Form [.pdf]
• Transfusion Form [.pdf]
• Response Assessment less than 20% blasts Form (v2.0) [.pdf]
• Response Assessment more than 20% blasts Form (v2.0) [.pdf]
• Concomitant Medication Form (v2.0) [.pdf]

 Observational

• Registration Form (v4.0) [.pdf]
• Eligibility Form (v3.0) [.pdf]
• Baseline Form (v2.0) [.pdf]
• Follow Up Form (v2.0a) [.pdf]
• Withdrawal Form (v1.0) [.pdf]
• Deviation Form (v1.0) [.pdf]
• Death Form (v1.0 )[.pdf]

• SAE Form (v2.0) [.pdf]
• SAE Fax cover sheet (v3.0) [.pdf]
• SAE Form coded list [.pdf]

Tools

• PHAZAR Patient Screening Enrolment Log (v.1.0) [.pdf]
• Sample Collection Form - Baseline only samples (v3.0) [.pdf]
• Sample Collection Form - Blood and BM (v3.0) [.pdf]
• Sample collection supplies Order Form (v3.0) [.pdf]

Pharmacy Documents

• Pharmacy Manual (v3.0) [.pdf]
• Ruxolitinib order form [.pdf]
• Azacitidine SPC [.pdf]
• Ruxolitinib SPC [.pdf]
• IDOS User Access request form - Non-Celgene user (v3.0) [.pdf]
• 5-azacitidine Master Accountability Log (v1.0a) [.pdf]
• Ruxolitinib 5mg Master Drug Accountability Log (v1.0) [.pdf]
• Ruxolitinib 15mg Master Drug Accountability Log (v1.0) [.pdf]
• Ruxolitinib 20mg Master Drug Accountability Log (v1.0) [.pdf]
• Phazar Temperature Deviation Form (v1.0) [.pdf]

Pharmacy File Version Control Checklists

• PHAZAR PF VC Checklist v6.0 [.pdf]
• PHAZAR PF VC Checklist v5.0 [.pdf]
• PHAZAR PF VC Checklist v4.0 [.pdf]
• PHAZAR PF VC Checklist v3.0 [.pdf]
• PHAZAR PF VC Checklist v2.0 [.pdf]
• PHAZAR PF VC Checklist v1.0 [.pdf] 

To date there are no publications available for this trial.

None at present

Chief Investigator
Dr Mark Drummond
Consultant Haematologist and Honorary Senior Lecturer
Haematology, Beatson Oncology Centre
Haematology Laboratory
21 Shelley Road, Gartnavel Hospital
Glasgow, G12 0XL

Tel:      +44 (0) 141 301 7712
Fax:     +44 (0) 141 301 7718

PHAZAR Trial Office
Trial Coordinator:               Mirjana Sirovica                     
Trial Monitor:                      Davina Scott
Trial Management Team Leader:    Sonia Fox
Trial Statistician:                Iklaaq Ahmed

Cancer Research UK Clinical Trials Unit (CRCTU)
Centre for Clincal Haematology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH

Enquiries
Telephone: +44 (0)121 371 7866
Fax:             +44 (0)121 371 7874
Email:          Phazar@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)121 371 7866                        (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44 (0)121 371 7874                          Or                         0121 371 4398

Sponsor

University of Birmingham
Correspondence to:
Cancer Research UK Clinical Trials Unit (CRCTU)
Centre for Clincal Haematology
Queen Elizabeth Hospital
Edgbaston,
Birmingham B15 2TH