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.

• UK Investigator Registration Form (PDF 200KB)
• UK Site Staff Registration Form (PDF 171 KB)
• Site Signature and Delegation Log (PDF 46KB)

 

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

• MyeChild 01 Laboratory Manual v3.0 21-Nov-2016 (PDF 563KB)
• MyeChild-01 Pharmacy Manual v3.0 22-Nov-2016 (PDF 743KB)
• For the Laboratory Manual for PK and ADA Assessments, please email the MyeChild 01 Trials Office.

Guidelines

•  SAE Form Completion Guidelines_v1.0_17Mar16 (PDF 164KB)
• CRF Completion Guidelines v2.0 19-Jul-2017 (PDF 477KB)
• eRDC User Manual v1.0 29-Sep-2016 (PDF 1539KB)

Case Report Forms

• MyeChild 01 Case Report Forms (current)

• Pharmacovigilance (SAEs, etc) [link]

Patient Information Sheets

• MyeChild 01 Patient Information Sheets [link]

Informed Consent Forms

• MyeChild 01 Informed Consent Forms [link]

GP Letters

• GP Letters [link]

Release of Medical Information

• Release of Medical Information (MS Word Document 699KB)

Version Control Lists 

• Investigator Site File and Pharmacy File Version Control Lists [link]

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.

• Substantial Amendment 01 [link]
• Substantial Amendment 02 [link]
• Substantial Amendment 04 [link]
• Substantial Amendment 07 [link]
• Substantial Amendment 08 [link]

Summary of Product Characteristics & Investigator's Brochure

• Summary of Product Characteristics & Investigator's Brochure [link]

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.

• Gemtuzumab Ozogamicin Order Form_v2.0_25-Aug-2017_editable (PDF 462KB)

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

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

Chief Investigator

Professor Brenda Gibson                                                                                

Cancer Research UK Consultant in Paediatric Oncology

Cancer Research UK Clinical Trials Unit (CRCTU)
Department of Cancer and Genomic 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:  Aaron Greene and Mahnoor Muzaffar
Senior Trial Coordinator: Paul Wetherell
Data Manager: Chloe Southall
Trial Monitor: Vidushi Chugh
Trial Management Team Leader: Anna Lawson
Trial Statistician: Aimee Houlton and Shanna Maycock

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
Email: myechild01@trials.bham.ac.uk

Trial Entry

MyeChild01 is now closed to trial entry. The trial is open for the minor dose finding study, please do contact the MyeChild01 trial office to enquire and register a patient:

E-mail: MyeChild01@trials.bham.ac.uk

Tel: +44 (0) 121 414 3366

Serious Adverse Event Reporting

SAE's should be e-mailed to the reg mailbox at the MyeChild-01 Trial Office, CTCTU, University of Birmingham, UK

reg@trials.bham.ac.uk

Sponsor

University of Birmingham

CRCTU Home Page

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