UK CLL Trials Portfolio as of July 2018

Summary of CLL Trials Portfolio ~ July 2018:

 



 

Currently Open or soon to OpenTrials

Future Planned Trials

(The 'future' trials may not happen due to funding, ethics etc.)

Patients considered fit for FCR (previously untreated)

CLL10 (FLAIR amendment) – Phase III FCR vs Ibrutinib+Rituximab vs Ibrutinib monotherapy vs Ibrutinib+venetoclax.

(FCRvR+I arm to close July 2018.)

 

 

-

 

 

Patients considered unfit for FCR (previously untreated)

BGB-3111-304_CLL Phase_3

(BGB-3111 vs Chlorambucil +Obinutuzumab)

Ibruitinib+Venetoclax vs Chlorambucil + Obinutuzumab (GLOW)

17p deleted CLL (previously untreated)

BGB-3111-304_CLL Phase_3

(BGB-3111 vs Chlorambucil +Obinutuzumab)

FLAIR amendment

 

 

Consolidation/Maintenance

 

-

INTERRUPT Trial

Stage A CLL

-

-

Richter’s Transformation

STELLAR: ACP-196 Bloodwise TAP Trial

(First patient planned to be recruited July 2018)

 

 

Relapsed/Refractory CLL

ATRi + Acalabrutinib study (ACE-CL-110)

Bloodwise ACALA CLL Trial

 

 

Relapsed 17p del CLL

ATRi + Acalabrutinib study (ACE-CL-110)

-

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/LICTR/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