MyeChild 01 Trial: For Investigators

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International Randomised Phase III Clinical Trial in Children with Acute Myeloid Leukaemia -Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination with Induction Chemotherapy

Change of Staff

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 MyeChild 01 Trial Office.

 

Trial Documents

Links to the current protocol, UK 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. UK Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, UK GP Letter, Release of Medical Information Form etc) can also be found below.

If you cannot find what you are looking for please email the MyeChild 01 Trials Office.

For non UK documentation please contact your National Coordinating Centre.  Details can be obtained from the MyeChild 01 Trials office.

Protocol and Trial Synopsis

For the current protocol and trial synopsis, please refer to the home page [link]

Other Trial Related Documents

Guidelines

Case Report Forms

Patient Information Sheets

Informed Consent Forms

GP Letters

Release of Medical Information

Version Control Lists 

Amendments

The links 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 Product Characteristics & Investigator's Brochure

Gemutuzumab Ozogamicin Order Form

This order form can be completed electronically.  Once complete, order forms can be faxed or emailed to the MyeChild 01 Trials Office.

 Please be aware that contrary to the Pharmacy Manual; you do not need to notify the MyeChild 01 Trial Office of drug receipt.  

News and Events

There is currently no news letter for the MyeChild 01 trial.  Once available a link will be provided.

Contact Details

Chief Investigator

Professor Brenda Gibson                                                                                

Cancer Research UK Consultant in Paediatric Oncology

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

Tel: +44 (0) 121 415 1049 

Email: brenda.gibson@ggc.scot.nhs.uk

MyeChild-01 Trial Office
Trial Coordinator:  Colin McAlister
Trial Coordinator:  Sabrina Cronier
Trial Administrator: Christopher Warmington
Data Manager: Eleanor Taylor
Trial Monitor: Kavita Mistry  
Trial Management Team Leader:  Nicola Fenwick
Trial Statistician: Aimee Houlton

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

Enquiries

Telephone: +44 (0) 121 415 1049
Fax: +44 (0) 121 414 9520
Email: myechild01@trials.bham.ac.uk

Trial Entry

Randomisation service supplied by the CRCTU at the University of Birmingham

Randomisation should be performed by sites online at:

https://www.cancertrials.bham.ac.uk/MyeChild01Live

In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on:

Tel: 0800 371 969

Tel: +44 (0) 121 414 3366

Serious Adverse Event Reporting

SAE's should be faxed to the MyeChild-01 Trial Office, CRCTU, University of Birmingham, UK

Fax: +44 (0) 121 414 9520 or +44 (0) 121 414 3700

Sponsor

University of Birmingham

CRCTU Home Page

http://www.birmingham.ac.uk/crctu