UK CLL Trials Portfolio as of Nov 2018


Summary of CLL Trials Portfolio ~ November 2018:



Currently Open or soon to OpenTrials


Future Planned Trials


Patients considered fit for FCR (previously untreated)

CLL10 (FLAIR) – Phase III 

FCR vs Ibrutinib monotherapy

vs Ibrutinib+venetoclax.

(FCRvR+I arm to closed in July 2018.)

Acerta ACE-CL-007



Patients considered unfit for FCR (previously untreated)

BGB-3111-304 CLL Phase_3

Zanubrutinib (BGB-3111) vs Chlorambucil+Obinutuzumab

GLOW trial 

Ibruitinib+Venetoclax vs Chlorambucil + Obinutuzumab 

Acerta ACE-CL-007

17p deleted CLL (previously untreated)

BGB-3111-304 CLL Phase_3 of

Zanubrutinib (BGB-3111) vs Chlorambucil+Obinutuzumab

FLAIR I+V arm for






Stage A CLL



Richter’s Transformation

Frontline and relapsed


CHOP-R in combination with ACP-196 Bloodwise TAP Trial

(First patient planned to be recruited Spring 2019)



Relapsed/Refractory CLL


Phase 1/Phase 2 ATRi + Acalabrutinib study 


Phase 1/Phase 2 dose escalation and cohort expansion study of SNS062 (Vecabrutinib) in patients with B cell malignancies




Relapsed 17p del CLL


ATRi + Acalabrutinib study 


Phase 1/Phase 2 dose escalation and cohort expansion study of SNS062 (Vecabrutinib) in patients with B cell malignancies


Randomised Study of Zanubrutinib (BG3111) compared to Ibrutinib in patients with relapsed/refractory CLL


Relapsed11q del CLL (T-PLL)


?HOVON T-PLL study








Phase III randomised trial to assess whether Ibrutinib+Rituximab or Ibrutinib + Venetoclax or Ibrutinib monotherapy is superior to Fludarabine, Cyclophosphamide and Rituximab (FCR) in terms of progression-free survival and secondary objectives overall survival, response, minimal residual disease negativity and relapse, toxicity, quality of life and health economics. Previously untreated patients are eligible if they are considered fit for FCR.


The FCR v Ibrutinib +Rituximab arm stopped in July 2018


The trial is sponsored by the Leeds Teaching Hospitals.





:APhase II, randomised study of CHOP-R in combination with acalabrutinib compared to CHOP-R in patients with newly diagnosed Richter’s Syndrome (RS) followed by an extension study to evaluate novel therapies in relapsed/refractory RS 


The trial is managed by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

This research is being funded by Bloodwise as part of the Trials Acceleration Program (TAP) and by Acerta Pharma. Acerta Pharma are providing free acalabrutinib for the study.





A Study Investigating AZD6738 Monotherapy (ATR Inhibitor) and Acalabrutinib in Combination With AZD6738 in Subjects With Relapsed or Refractory High-risk Chronic Lymphocytic Leukemia (CLL)


AZD6738 is an ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).




An International Trial currently recruiting in the UK at:


Leeds Teaching Hospitals NHS Trust

University of Oxford
Nottingham University Hospitals NHS Trust
Cardiff and Vale UHB Headquarters
Cambridge University Hospitals NHS Trust

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
King's College London
Barts Health NHS Trust
University College London (UCL) - Cancer Research UK & UCL Cancer Trials Centre
University of Southampton
University of Birmingham
University of Liverpool


BGB-3111-304 see attachment below