CALiBRe

CALiBRe: Assessment of the Mechanism of Action of idelalisib (CAL-101) in B-cell Receptor Pathway Inhibition in CLL

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. 

Trial Documents

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 CALiBRe Trial Office.

Protocol

Patient Documents

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 Investigator Site File Version Control Lists used in this trial are below in reverse date order.

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.

 Guidelines

Other Documents

  • CALiBRe FAQ [.pdf] (coming soon)

Case Report Forms

Case Report Forms

Tools

Pharmacy

Pharmacy Documents

Pharmacy File Version Control Checklists

Publications

Rawstron, A; Howard, D; McParland, L;  de Tute, RM; Collett, L; Phillps, D; Chalmers, A; Varghese, AM; Munir, T; Gregory, WM; Bishop, R; Yates, FJ;  Brock, K; Muñoz-Vicente, S; Hillmen, P. "Compartment Effect on the Prognostic Significance of MRD Detection in CLL: Impact of Treatment Type and Duration of Follow-up". American Society of Haematology, 58th Annual Meeting and Exposition, December 3-6, 2016 (accepted as a poster).

News and Events

CALiBRe News

CALiBRe Substantial Amendment 4 has received full regulatory approval and the trial is now open to recruitment again! 

CALiBRe was temporarily halted on 14 March 2016 due to Urgent Safety Measures.  The trial has been re-written to address the safety concerns raised in a number of other clinical trials involving the use of idelalsib in front-line patients.

The updated protocol and associated documents contain major changes to the inclusion and exclusion criteria and new safety information about idelalisib.   

Trial Milestones

  • CALiBRe opened to recruitment on 13-Jul-2015
  • The first patient was registered to CALiBRe on 06-Aug-2015

Newsletters

Contact Details

Chief Investigator
Professor Peter Hillmen
Department of Haematology
Level 3, Bexley Wing
St.  James’s University Hospital
Beckett Street
Leeds, LS9 7TF

Tel:      +44 (0)113 206 8513

CALiBRe Trial Office
Trial Coordinator:        Dr Francesca Yates                                                    
Trial Monitor:               Semsem Abdulle                   
Trial Management Team Leader:     Shamyla Siddique                          

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

Enquiries
Telephone: +44 (0)121 415 9146
Email:        CALiBRe@trials.bham.ac.uk

Trial Entry
Telephone: +44  (0)121 415 9146 (9:00am to 5:00pm Monday to Tuesday)

Serious Adverse Event Reporting
Fax: +44  (0)121 414 6061 or  +44  (0)121 414 3700

Sponsor: University of Birmingham