UK CLL Clinical Trials Portfolio as of May 2019

Summary of CLL Trials Portfolio ~ May 2019:

 

 

 

Currently Open or soon to Open Trials

Future Planned Trials

Patients considered fit for FCR (previously untreated)

CLL10 (FLAIR) – Phase III

FCR vs Ibrutinib monotherapy vs Ibrutinib+venetoclax.

(FCRvR+I arm closed in July 2018.)

Recruitment scheduled to close late 2019

 

 

Acerta ACE-CL-007

 

 

Patients considered unfit for FCR (previously untreated)

 

 

 

 

Acerta ACE-CL-007

17p deleted CLL (previously untreated)

 FLAIR I+V arm for 17p/P53mutated

 

 

Consolidation/Maintenance

 

-

INTERRUPT Trial (Ibrutinib)

Stage A CLL

OXLORED Observational Study

Planned to open for recruitment late 2019

 

Richter’s Transformation

Frontline and relapsed

STELLAR: CHOP-R vs CHOP-R in combination with ACP-196 Bloodwise TAP Trial

(First patient planned to be recruited Spring 2019)

 

 

Relapsed/Refractory CLL

Beigene BGB-3111-305_CLL_Phase_3

Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic

Lymphoma

 

Relapsed/Refractory CLL

Phase 1/Phase 2 ATRi + Acalabrutinib study (ACE-CL-110)

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

 

Zuma-8 CAR-T Cell Trial

Relapsed 17p del CLL

Phase 1/Phase 2 ATRi + Acalabrutinib study (ACE-CL-110)

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

 

Zuma-8 CAR-T Cell Trial

 

Relapsed 11q 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-rituximab-chronic-lymphocytic-leukaemia-flair

NIHR Flair

 

 

STELLAR

 

A Phase 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 acalabrutinib and other 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.

 

Recruiting is scheduled to include:

 

Oxford Churchill Hospital

St James Hospital Leeds

Beatson WOSCC

Belfast City Hospital

Clatterbridge Cancer Centre

Kings College Hospital

Leicester Royal Infirmary

Nottingham City Hospital

Queen Elizabeth Birmingham

Royal Bournemouth Hospital

Sheffield Hallam Hospital

Southampton General

St Bartholomew’s Hospital

The Christie

University Hospital of Wales

University College London

 

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 oral ATR kinase inhibitor.

Acalabrutinib is a new generation oral BTK inhibitor.

 

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

 

An International Trial sponsored by Acerta Pharma BV and 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

 

 

 

OXLORED Study

 

This is a study to identify the clinical, genomic and immunological predictive markers of progression to malignant disease.

It will be open to individuals diagnosed in the last 2 years with high count MBL, Binet Stage A CLL, IgG/ IgG/ IgM MGUS, asymptomatic WM not requiring treatment, and smouldering myeloma not requiring treatment.

 

The study is being undertaken by the University of Oxford and recruitment is planned to commence in 2019.

 

 

GWB

May 2019