IcICLLe

IcICLLe: Assessment of the Mechanism of Action of Ibrutinib (PCI-32765) in B-cell Receptor Pathway Inhibition in Chronic Lymphocytic Leukaemia (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. 

  • Investigator Registration Form [.pdf]
  • Site Staff Registration Form [.pdf]
  • Delegation Log [.pdf]

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 IcICLLe Trial Office.

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

Patient Documents

  • Patient Information Sheet and Informed Consent Form v8.0a [.docx] (Extension Study patients) new!
  • Addendum B(i) to Patient Information Sheet and Consent Form v5.0 [.docx] (monotherapy patients) 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.

  • IcICLLe ISF VC Checklist v13.0_02-Dec-2016 [.pdf] new!
  • IcICLLe ISF VC Checklist v12.0_26-Apr-2016 [.pdf]
  • IcICLLe ISF VC Checklist v11.0_28-Jan-2016 [.pdf]
  • IcICLLe ISF VC Checklists v1.0 to v11.0 [.zip]

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

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

Other Trial Documents

  • IcICLLe FAQ [.pdf] (coming soon)

Case Report Form

Case Report Form

  • Registration Form[.pdf]
  • Eligibility Form [.pdf]  new!
  • Baseline Form  [.pdf] new!
  • Treatment Form Day 0 [.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]
  • Treatment Form Month 6 [.pdf] new!
  • Treatment Form Month 9 [.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]  new! right click and select 'save link as...' to download
  • SAE Fax Cover [.pdf] new! right click and select 'save link as...' to download

Tools

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

Sample Request Forms - new

  • Belfast City Hospital:   Main Trial [.pdf] and Extension Study [.pdf]
  • QEH Birmingham:   Main Trial [.pdf] and Extension Study [.pdf]
  • UHW Cardiff:   Main Trial [.pdf] and Extension Study [.pdf]
  • The Christie:   Main Trial [.pdf] and Extension Study [.pdf]
  • Hammersmith Hospital:   Main Trial [.pdf] and Extension Study [.pdf]
  • Kings College Hospital:   Main Trial [.pdf] and Extension Study [.pdf]
  • St James's Hospital Leeds:   Main Trial [.pdf] and Extension Study [.pdf]
  • The Royal Liverpool:   Main Trial [.pdf] and Extension Study [.pdf]
  • Nottingham City Hospital:   Main Trial [.pdf] and Extension Study [.pdf]

Pharmacy

Pharmacy Documents

  • Pharmacy Manual [.pdf] new!
  • Ibrutinib order form [.pdf]
  • Ibrutinib SPC [opens a new window]
  • Obinutuzumab order form [.pdf]
  • Obinutuzumab SPC [opens a new window]
  • Ibrutinib IMP deviation form [.docx] new!
  • Obinutuzumab IMP deviaton form [.docx] new!

Pharmacy File Version Control Checklists

  • IcICLLe PF VC Checklist v9.0_02-Dec-2016  [.pdf] new!
  • IcICLLe PF VC Checklist v8.0_18-Dec-2015  [.pdf]
  • IcICLLe PF VC Checklists v1.0 to v8.0  [.zip]

Publications

IcICLLe has been presented at the following meetings:

Rawstron, A; Munir, T; Muñoz-Vicente, S; Brock, K; Yates, FJ; Bishop, R; Dalal, S; de Tute, RM; Bloor, A; Sheehy, O; Pettit, A; Fox, C; Fegan, C; Devereux, S; Macdonald, D; Hillmen, P. "Addition of Obinutuzumab to Ibrutinib Enhances Depletion of CLL Cells in the Peripheral Blood and Bone Marrow after 1 Month of Combination Therapy: Initial Results from the Bloodwise TAP Iciclle Extension Study".  American Society of Haematology, 58th Annual Meeting and Exposition, December 3-6, 2016 (accepted as a poster).

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).

Talha Munir, AndyC. Rawstron, Kimone Eccleston, Surita Dalal, Ruth M. de Tute, Kristian Brock, Francesca Yates, Adrian Bloor, Christopher P. Fox, Chris Fegan, Donald Macdonald, Peter Hillmen. "The TAP IcICLLe trial assessing biological response to ibrutinib in CLL: immediate disease redistribution precedes cell cycle arrest by 2 weeks with reduced bone marrow infiltration by 6 months."  36th World Congress of the International Society of Haematology, hosted by the British Society for Haematology, Apr 2016 (accepted as a poster)

Rawstron, A; Munir, T; Dalal, S; Thompson, J; de Tute, R; Brock, K; Yates, F; Bloor, A; Fox, C; Fegan, C; MacDonald, D; Hillmen, P. The LLR TAP IciCLLe trial assessing biological response to ibrutinib in CLL: Immediate disease redistribution precedes cell cycle arrest by 2 weeks with reduced bone marrow infiltration by 6 months." National Cancer Research Institute 2015 (accepted as poster)

Rawstron, A; Munir, T; Dalal, S; Thompson, J; Yap, C; Brock, K; Yates, F; Ogburn, E; Fox, C; MacDonald, D; Fegan, C; Bloor, A; Hillmen, P. The LLR TAP IciCLLe trial assessing biological response to ibrutinib in CLL: Immediate disease redistribution precedes cell cycle arrest by 2 weeks with reduced bone marrow infiltration by 6 months." European Haematology Association 2015, Abstr. 4163 (accepted as oral presentation).

Rawstron, A; Munir, T; Eccleston, K; Dalal, S; de Tute, RM; Brock, K; Yates, F; Bloor, A; Fox, C; Fegan, C; Macdonald, D; Hillmen, P. “The LLR TAP IciCLLe Trial: Detailed assessment of the response to Ibrutinib provides insights into the mode of action and pattern of response in treatment naïve and refractory CLL”. XVI International Workshop on CLL 2015 (accepted as poster).

News and Events

IcICLLe News

IcICLLe Substantial Amendment 8 has just received approval.  The protocol and associated documents have been updated with safety information about both IMPs.  

15-Mar-2017 - 3 slots left!

We have 3 remaining slots available for the IcICLLe Extension Study - please contact us to reserve a place before giving out an information sheet to a potential patient.

Trial Milestones

  • The initial phase of IcICLLe opened on 12-Jun-2016 and recruitment of all 40 patients was completed in March 2015!
  • The IcICLLe Extension Study opened on 04-Dec-2016
  • The first patient was registered to the IcICLLe Extension Study on 22-Jan-2016
  • Patient 10 was registered on 27-Apr-2016
  • Patient 20 was registered on 13-Jun-2016 
  • Patient 30 was registered on 23-Aug-2016

Newsletters

  • IcICLLe Newsletter - February 2017 [.pdf] new!
  • IcICLLe Newsletter - December 2016 [.pdf] 
  • IcICLLe Newsletter - October 2016 [.pdf] 
  • IcICLLe Newsletter - August 2016 [.pdf]
  • IcICLLe Newsletter - June 2016 [.pdf]
  • IcICLLe Newsletter - March 2016 [.pdf]
  • IcICLLe Newsletter - January 2016 [.pdf]
  • IcICLLe Newsletter - December 2015 [.pdf]
  • IcICLLe Newsletter - November 2015 [.pdf]
  • IcICLLe Newsletter - October2015 [.pdf]
  • IcICLLe Newsletter - July 2015 [.pdf]
  • IcICLLe Newsletter - April 2015 [.pdf]
  • IcICLLe Newsletter - January 2015 [.pdf]
  • IcICLLe Newsletter - December 2014 [.pdf]
  • IcICLLe Newsletter - November 2014 [.pdf]
  • IcICLLe Newsletter - October 2014 [.pdf]
  • IcICLLe Newsletter - September 2014 [.pdf]
  • IcICLLe Newsletter - August 2014 [.pdf]

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

IcICLLe Trial Office

Trial Coordinator:         Dr Francesca Yates                            
Trial Monitor:                Saika Kauser                               
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 9176
Email:         IcICLLe@trials.bham.ac.uk

Trial Entry
Telephone: +44  (0)121 415 9176 (9:00 to 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