MAJIC

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 MAJIC Trial Office.

Protocol

• MAJIC Protocol v7.0_14-Jul-2015 [.pdf]
• MAJIC Trial Summary v5.0_28-Jan-2016 [.pdf]

Patient Documents

• Patient Information Sheet [.docx]
• Informed Consent Form [.docx]
• GP Letter  [.docx]
• Release of Medical Information Form [.docx]
• Patient Cards [.pdf]
• Patient Diary [.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.

• ISF Version Control Checklist (SA 16)_10-Sep-2015 [.pdf]
• ISF Version Control Checklist (v5.1)_18-Mar-2015 [.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]
• MAJIC Amendments (opens new page)

 Guidelines

• MAJIC Trial Guidelines  [.pdf]
• Event Form Completion Guidelines  [.pdf]
• MAJIC Sample Collection Guidelines [.pdf]
  • Sample Collection Form - Cambridge v1.5_30-Jan-2015 [.pdf]
  • Sample Collection Form - GSTT v1.6_30-Jan-2015 [.pdf]

Other Trial Documents

• Baseline-MPN-SAF-Booklet v1.0_17-Jul-2012 [.pdf]
• Baseline Quality of Life Questionnaire v1.0_17-Jul-2012 [.pdf]
• Quality of Life Questionnaire v1.1_17-Jan-2013 [.pdf]

Case Report Forms

• Randomisation Form[.pdf]
• Eligibility Form [.pdf]
• On-Study Form  [.pdf]
• Follow Up Form  [.pdf]
• Treatment Form year 1 v3.0_30-Jan-2015 [.pdf]
• Treatment Form BAT arm form years 2-5 v4.0_30-Jan-2015 [.pdf]
• Treatment Form BAT arm form years 2-5 SAE Continuation Sheet v1.0_28-Apr-2014 [.pdf]
• Treatment Form Ruxolitinib arm form years 2-5 v4.0_30-Jan-2015 [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• MAJIC Event Form  [.pdf]

Pharmacy Documents

• MAJIC Pharmacy Manual v3.0_30-Jan-2015 [.pdf]

Pharmacy Version Control Documents

• PF Document Version Control Checklist (SA 16)_08-Oct-2015 [.pdf]
• PF Document Version Control Checklist (v5.0)_25-Mar-2015 [.pdf]

Harrison, C ; Mead, A; Panchal, A; Fox, S; Yap, C; Houlton, A; Aliman, S; Wood, M;  Chen, F; Coppell, J; Panoskaltsis, N; Scherber, R; Geyer, H; Dueck, A; Mesa, R;  McMullin, M. "Ruxolitinib Compared with Best Available Therapy for Essential Thrombocythemia PatientsResistant or Intolerant to Hydroxycarbamide in MAJIC - An Investigator-Led Randomised Trial." European Hematology Association 2016

Harrison, C; Mead, A; Fox, S; Bell, H; Alimam, S; Green, A; Wood, M; Ewing, J; Chen, F; Yap, C; Ahmed, I; Coppell, J; Knapper, S; McMullin, M. "Feasibility of recruitment of hydroxyurea-resistant or intolerant Essential Thombocythaemia and Polycythaemia Vera patients into the MAJIC study." British Society of Haematology 2015

Scherber, R; Fox, S, Kosiorek, H, Shah, M; Abdi-Moradi, S; Mead, A; Bell, H; Dueck, A; Aliman, S; Green, A; Wood, M; Ewing, J; Chen, F; Coppell, J; Knapper, S; McMullin, M; Geyer, H; Mesa, R; Harrison, C. "Baseline Quality of Life and Symptom Burden Characteristics of Patients Intolerant to Hydroxyurea: Preliminary results from the MAJIC Trial." British Society of Haematology 2015

Harrison, C; Mead, A; Fox, S; Bell, H; Alimam, S; Green, A; Wood, M; Ewing, J; Chen, F; Yap, C; Ahmed, I; Coppell, J; Knapper, S; McMullin, M. "Feasibility of recruitment of hydroxyurea-resistant or intolerant Essential Thombocythaemia and Polycythaemia Vera patients into the MAJIC study." NCRI Cancer Conference 2015

Scherber, R; Fox, S, Kosiorek, H, Shah, M; Abdi-Moradi, S; Mead, A; Bell, H; Dueck, A; Aliman, S; Green, A; Wood, M; Ewing, J; Chen, F; Coppell, J; Knapper, S; McMullin, M; Geyer, H; Mesa, R; Harrison, C. "Baseline Quality of Life and Symptom Burden Characteristics of Patients Intolerant to Hydroxyurea: Preliminary results from the MAJIC Trial." NCRI Cancer Conference 2015

No current news or upcoming events

Newletters

• MAJIC Newsletter March 2016 [.pdf]
• MAJIC Newsletter November 2015 [.pdf]
• MAJIC Newsletter August 2015 [.pdf]
• MAJIC Newsletter July 2015 [.pdf]
• MAJIC Newsletter June 2015 [.pdf]
• MAJIC Newsletter May 2015 [.pdf]
• MAJIC Newsletter March 2015 [.pdf]
• MAJIC Newsletter December 2014 [.pdf]
• MAJIC Newsletter June 2014 [.pdf]
• MAJIC Newsletter December 2013 [.pdf]
• MAJIC Newsletter August 2013 [.pdf]
• MAJIC Newsletter December 2012 [.pdf]

Chief Investigator
Name: Professor Claire Harrison
Addresss:
Guy’s Hospital
Great Maze Pond
London, SE1 9RT

Tel:      +44 (0)121 415 9181
Fax:     +44 (0)121 414 6061
Email: majic@trials.bham.ac.uk

MAJIC Trial Office
Trial Coordinator:       Sonia Fox                            
Trial Administrator:       Samuel Bicknell                                
Trial Monitor:       Poonam Patel/Semsem Abdulle                     
Trial Management Team Leader:       Shamyla Siddique
Trial Statistician:       Anesh Panchal               

Cancer Research UK Clinical Trials Unit (CRCTU)
Department of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Telephone: +44 (0)121 415 9181
Fax:              +44 (0)121 414 6061
Email:        majic@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0)800 371 969              (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44  (0)121 414 6061   Or   +44 (0)121 414 3700

Sponsor: The University of Birmingham