SeluDex: For Investigators

International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexmaethasone for the treatment of replapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia

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 Site Signature and Delegation Log is updated. Return both documents to the SeluDex Trial Office.

Trial Documents

Links to the current Protocol, Patient Information Sheets and Informed Consent Forms 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 Forms, 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 SeluDex Trial Office.

Patient Documents

Patient Information Sheets 

Pre-trial Genetic Assessment (RAS mutation testing)
Phase I (Dose Finding)
Phase II (Dose Expansion)
Phase I & II (Dose Finding & Expansion)

Informed Consent Forms

Pre-trial Genetic Assessment (RAS mutation testing)
Phase I (Dose Finding)
Phase II (Dose Expansion)

GP Letters

Patient Diaries

Other 

Serious Adverse Event / Dose Limiting Toxicity Reporting

Investigator Brochure & Summaries of Product Characterisitics

The latest Investigator’s Brochures and Summary of Product Characteristics provided to the SeluDex Trial Office are available below. Please ensure the latest versions are available in both the Investigator Site File and Pharmacy File. Whilst all the latest Investigator’s Brochures and Summary of Product Characteristics are provided to sites immediately for their reference, these will be submitted yearly to the MHRA by substantial amendment ahead of the DSUR deadline in May.

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.

Regulatory Approvals

Below is a link to a new page containing all of the regulatory approval documents including information on all amendments which have been made for this trial. 

Case Report Form

Sample Collection

Site specific versions of Sample Collection Forms, further supplies of Laboratory Consumables and Sample Labels are available from the SeluDex Trial Office.

Guidelines & Other Trial Documents

Publications

To date there are no publications available for this trial

News and Events

There is no current news or events for this trial

Contact Details

Chief Investigator

Dr Tobias Menne
Consultant Haematologist
Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK, NE7 7DN

Tel: +44 (0)191 213 8659

International Lead Investigator

Professor Josef Vormoor
Consultant Paediatric Haematologist
Princess Maxima Center for Pediatric Oncology, 3584 EA Utrecht, The Netherlands

SeluDex Trial Office

Trial Coordinator                                 

Sarah Johnson

Senior Trial Coordinator

Siraj Takolia

Trial Monitor                                       

Jennifer Keely

Trial Management Team Leader

Joshua Savage

Trial Statistician

Ayesha Ali

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

Enquiries

Telephone: +44 (0) 121 414 6754
Fax: +44 (0) 121 414 3529
Email: seludex@trials.bham.ac.uk

Trial Entry Registration

Telephone: 0121 414 6754 (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

Fax: 0121 414 3529 (Primary)
Fax: 0121 414 3700 (Secondary)

Sponsor

University of Birmingham, Edgbaston, Birmingham, UK, B15 2TT

CRCTU Home Page

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