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. 

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.

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 Trial Documents

  • IcICLLe FAQ [.pdf] (coming soon)

Case Report Form

Case Report Form

  • SAE Fax Cover [.pdf] new! right click and select 'save link as...' to download

Tools

Sample Request Forms - new

Pharmacy

Pharmacy Documents

Pharmacy File Version Control Checklists

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

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