CALiBRe

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. 

• 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 CALiBRe Trial Office.

Protocol

• Protocol [.pdf] new!
• Trial Summary [.pdf] new!

Patient Documents

• Patient Information Sheet and Consent Form [.docx] new!
• GP Letter [.docx] new!
• Release of Medical Information Form [.docx]
• Patient Diary  [.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 Investigator Site File Version Control Lists used in this trial are below in reverse date order.

• CALiBRe ISF VC Checklist v9.0_14-Jun-2017 [.pdf] new!
• CALiBRe ISF VC Checklist v8.0_19-Apr-2016 [.pdf]
• CALiBRe ISF VC Checklist v7.0_28-Jan-2016 [.pdf]
• CALiBRe ISF VC Checklist v6.0_ 21-Dec-2015 [.pdf]
• CALiBRe ISF VC Checklist v5.0_05-Oct-2015 [.pdf]
• CALiBRe ISF VC Checklist v4.0_21-Sep-2015 [.pdf]
• CALiBRe ISF VC Checklist v3.0_26-Aug-2015 [.pdf]
• CALiBRe ISF VC Checklist v2.0_27-Jul-2015 [.pdf]
• CALiBRe ISF VC Checklist v1.0_15-May-2015 [.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.

• Summary of Amendments [.pdf]
• CALiBRe Amendments (opens new page)

 Guidelines

• CRF Completion Guidelines  [.pdf] new!
• SAE Form Completion Guidelines  [.pdf]
• Informed Consent Guidelines [.pdf]
• Sample Collection Guidelines  [.pdf] new!
• HMDS Report Interpretation Gudielines [.pdf]

Other Documents

• CALiBRe FAQ [.pdf] (coming soon)

Case Report Forms

• Registration Form [.pdf] new!
• Eligibility Form [.pdf] new!
• Baseline Form  [.pdf] new!
• Treatment Form Day 1 [.pdf]  new!
• Treatment Form Day 2 [.pdf] new!
• Treatment Form Day 8 [.pdf] new!
• Treatment Form Day 15 [.pdf] new!
• Treatment Form Month 1 [.pdf] new!
• Treatment Form Month 3 [.pdf] new!
• Treatment Form Month 6 [.pdf] new!
• Treatment Form Ongoing  [.pdf] new!
• Concomitant Medication Form [.pdf] new!
• Adverse Events Form  [.pdf] new!
• Treatment Discontinuation Form  [.pdf] new!
• Disease Response Form  [.pdf] new!
• Withdrawal Form  [.pdf]
• Notification of Death Form  [.pdf]
• Deviation Form  [.pdf]
• Follow Up Form  [.pdf]
• Pregnancy Notification Form [.pdf]
• SAE Form (electronic) [.pdf] right click and select 'save link as...' to download

• SAE Fax Cover Sheet [.pdf]

Tools

• Sample Collection Record [.pdf] new!
• Clinic Checklist [.pdf] new!

Pharmacy Documents

• Pharmacy Manual  [.pdf] new!
• Idelalisib order form  [.pdf]
• Idelalisib SPC (opens a new window)

Pharmacy File Version Control Checklists

• CALiBRe PF VC Checklist v3.0_14-Jun-2017 [.pdf] new!
• CALiBRe PF VC Checklist v2.0_27-Jul-2015  [.pdf]
• CALiBRe PF VC Checklist v1.0b_30-Jun-2015  [.pdf]

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).

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

• CALiBRe Newsletter 10 - March 2017 [.pdf] new!
• CALiBRe Newsletter 9 - November 2016 [.pdf]
• CALiBRe Newsletter 8 - October 2016 [.pdf]
• CALiBRe Newsletter 7 - March 2016 [.pdf]
• CALiBRe Newsletter 6 - January 2016 [.pdf]
• CALiBRe Newsletter 5 - December 2015 [.pdf]
• CALiBRe Newsletter 4 - November 2015 [.pdf]
• CALiBRe Newsletter 3 - October 2015 [.pdf]
• CALiBRe Newsletter 2 - September 2015 [.pdf]
• CALiBRe Newsletter 1- July 2015 [.pdf]

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