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

17p/P53mutated

Consolidation/Maintenance

 

-

 

Stage A CLL

-

OXLORED Study

Richter’s Transformation

Frontline and relapsed

STELLAR:

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

(First patient planned to be recruited Spring 2019)

 

 

Relapsed/Refractory CLL

ACE-CL-110

Phase 1/Phase 2 ATRi + Acalabrutinib study 

Sunesis

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

 

 

 

Relapsed 17p del CLL

ACE-CL-110

ATRi + Acalabrutinib study 

Sunesis

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

BGB-3111-305

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

 

Relapsed11q del CLL (T-PLL)

 

?HOVON T-PLL study

 

 

 

 

 

CLL10 FLAIR

 

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. 

http://medhealth.leeds.ac.uk/info/443/haematological/1662/flair

http://www.cancerresearchuk.org/about-cancer/trials/a-trial-ibrutinib-ri...

https://www.ukctg.nihr.ac.uk/trials

UKCTG Flair

 

STELLAR

 

: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.

 

 

ACE-CL-110

 

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).

 

See: https://clinicaltrials.gov/ct2/show/NCT03328273

 

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