BREVITY

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 BREVITY Trial Office.

• 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 BREVITY Trial Office.

Protocol

• Protocol [.pdf]
• Trial Sumary [.pdf]

Patient Sheets

• Patient Information Sheet [.pdf]
• PIS Addendum B [.pdf]
• GP Letter  [.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.

Investigator Site Folder

• Version Control Checklist - v10.0 27-Aug-2015 [.pdf]
• Version Control Checklist - v9.0 26-Mar-2015  [.pdf]
• Version Control Checklist - v8.0 08-Jan-2015  [.pdf]
• Version Control Checklist - v7.0 16-Dec-2014  [.pdf]
• Version Control Checklist - v6.0 05-Aug-2014 [.pdf]
• Version Control Checklist - v5.0 28-Apr-2014 [.pdf]
• Version Control Checklist - v4.0 03-Apr-2014 [.pdf]
• Version Control Checklist - v3.0 18-Feb-2014 [.pdf]
• Version Control Checklist - v2.0 27-Jan-2014  [.pdf]
• Version Control Checklist - v1.0 30-Jul-2013 [.pdf]

Pharmacy Folder

• Version Control Checklist - v4.0 07-May-2014  [.pdf]
• Version Control Checklist - v3.0 01-Apr-2014 [.pdf]
• Version Control Checklist - v2.1 06-Feb-2014  [.pdf]
• Version Control Checklist - v2.0 Jan-2014  [.pdf]
• Version Control Checklist - v1.0 30-Jul-2013  [.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.

• Amendments (opens new page)

 

 Guidelines

• BREVITY Trial Guidelines  [.pdf]
• BREVITY PET-CT manual [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Brentuximab Spc [.pdf]

Case Report Forms

• Registration Form[.pdf]
• Eligibility Form [.pdf]
• Baseline Form  [.pdf]
• Treatment Form - Cycle 1  [.pdf]
• Treatment Form - Cycle 1 Day 15 bloods [.pdf]
• Treatment Form - Cycle 2-16 [.pdf]
• Cycle 4 Cheson Resposne form [.pdf]
• Concomitant Medication Form  [.pdf]
• Adverse Events Form  [.pdf]
• End of Treatment form 30 day assessment Form [.pdf]
• Non-progressed patient Follow-up From [.pdf]
• Progressed patient Follow-up Form  [.pdf]
• Progression-Relaspe Form [.pdf]
• Treatment Discontinuation Form  [.pdf]
• Pregnancy Notification Form  [.pdf]
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• PET 4 form  [.pdf]
• SAE Form  [.pdf]

All CRFs [.zip]

To date there are no publications for this trial.

An abstract has been submitted to ISHL 10 for October 2016

The BREVITY trial is now fully recruited.  Site closure will occur once all patients have completed treatment and follow-up. 

Newsletters

June 2016 [.pdf]

Christmas 2015 [.pdf]

March 2015 [.pdf]

Christmas 2014 [.pdf]

September 2013 [.pdf]

Chief Investigator
Prof John Radford
Department of Medical Oncology, Christie Hospitals NHS Foundation Trust, Wilmslow Raod, Mancheter, M20 4BX

Email:  BREVITY@trials.bham.ac.uk 

Tel:      +44 (0)161 446 3753

BREVITY Trial Office
Trial Coordinator:                               Dr Eszter Nagy                                   
Trial Management Team Leader:    Miss Shamyla Siddique
Trial Statistician:                                 Miss Sarah Pirrie

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

Enquiries
Telephone: +44 (0)121 414 7673
Fax:             +44 (0)121 414 6061
Email:        BREVITY@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

University of Birmingham