MITHRIDATE

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. Return both documents to the MITHRIDATE Trial Office.

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

Links to the current Protocol and Patient Documents 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. Guidelines, QoL Booklets, Amendments, etc.) can be found by clicking on the other menu items below. If you cannot find what you are looking for, please contact the MITHRIDATE Trial Office. 

• Protocol [.pdf]
• Trial Summary [.pdf]

Patient Documents

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

Guidelines

• Pharmacy Manual [.pdf]
• SAE Form Completion Guidelines [.pdf]
• Tissue sample collection guidelines [.pdf]

 

CRF & eRDC Guidelines:

• CRF and eCRF Completion Guidelines [.pdf]
• eRDC User Manual [.pdf]
• eRDC Randomisation Manual [.pdf]

Other Trial Documents

• Quality of Life Questionnaires:
  • Baseline MPN SAF Booklet [.pdf]
  • Baseline QoL Questionnaire Booklet [.pdf]
  • QoL Questionnaire Booklet (BAT visits) [.pdf]
  • QoL Questionnaire Booklet (Ruxolitinib visits) [.pdf]

• Patient Diaries:
  • Patient Diary Hydroxycarbamide [.pdf]
  • Patient Diary Interferon [.pdf]
  • Patient Diary Ruxolitinib [.pdf]
• Summary of Product Characteristics:
  • Hydroxycarbamide 500mg [.pdf]
  • Interferon (pegasys) 90mcg [.pdf]
  • Ruxolitinib 5mg [.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 04, 12-Jul-2022 (this amendment was not applicable to sites)
• Amendment 03, 22-Sep-2021 [opens new page]
• Amendment 02, 19-Mar-2020 [opens new page]
• Amendment 01, 08-Nov-2019 [opens new page]

Version Control Lists

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

• Version Control List V15 - Investigator Site File [.pdf]
• Version Control List V10 - Pharmacy File [.pdf]

Newsletters

Current Newsletter

• Newsletter - Easter 2023 [.pdf]

Previous Newsletters

• Newsletter - Christmas 2022 [.pdf]
• Newsletter - Autumn 2022 [.pdf]
• Newsletter - Summer 2022 [.pdf]
• Newsletter - Easter 2022 [.pdf]
• Newsletter - Christmas 2021 [.pdf]
• Newsletter - Autumn 2021 [.pdf]
• Newsletter - Summer 2021 [.pdf]
• Newsletter - Easter 2021 [.pdf]
• Newsletter - Christmas 2020 [.pdf]
• Newsletter - Covid-19 Newsletter (Spring 2020) [.pdf]
• Newsletter - Initial Newsletter (Summer 2019) [.pdf]

Chief Investigators

Professor Claire Harrison, Guy's Hospital, Great Maze Pond, London, SE1 9RT

Email: Claire.Harrison@gstt.nhs.uk

Professor Jean-Jacques Kiladjian (France), Clinical Investigations Centre, Saint-Louis Hospital, Paris, France

Email: jean-jacques.kiladjian@aphp.fr

MITHRIDATE Trial Office

Senior Trial Coordinator: Yolande Jefferson-Hulme
Trial Coordinator: Alex Hainsworth 
Trial Administrator: Diana Santiago

Trial Monitor: Vitalis Nwokorie
Trial Management Team Leader: Claire Gaunt
Senior Trial Statistician: Aimee Jackson
Trial Statistician: Fitsum Ghebretinsea

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

Enquiries

Email (primary point of contact): Mithridate@trials.bham.ac.uk
Tel: +44 (0)121 414 2535

Serious Adverse Event Reporting

Email: reg@trials.bham.ac.uk

Sponsor

University of Birmingham