CLL Support Association
UK CLL Trials Portfolio
The following is a review of the CLL Trials open for recruitment in the UK as of July 2017.
The trials are grouped in relation to patient condition:
CLL 9 RIALtO
A Phase III randomised trial to compare Ofatumumab plus Chlorambucil (O-Ch) with Ofatumumab and Benamustine (O-B) plus Idealisib or placebo for previously untreated patients not considered fit for FCR. The idelalisib arms have been stopped due concerns over safety and the trial continues to recruit participants into the O-Ch versus O-B arms.
This trial is jointly sponsored by the University of Liverpool and The Royal Liverpool & Broadgreen University Hospital NHS Trust. The trial opened in December 2011 and planned recruitment close date : 30 April 2017. (May be extended by 12 months)
CLL 10 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 trial is sponsored by the Leeds Teaching Hospitals.
Bloodwise TAP CLARITY Phase II Trial
Ibrutinib + Venetoclax (GDC-0199; ABT-199)
This is a prospective, single arm, multicentre study to assess the eradication of detectable minimal residual disease using the combination of Ibrutinib and Venetoclax, a selective BCL2 inhibitor.
CLARITY opened to recruitment in June 2016.
Bloodwise TAP CALiBRe Phase II Trial (formerly LLR TAP)
A feasibility study to investigate the mechanism of action of Idelalisib and the biological response to Idelalisib in treatment naive and in relapsed/refractory patients.
Recruiting currently on hold. Planned to reopen on early 2017 for Relapsed/Refractory CLL patients only and those who are intolerant of, or relapse whilst taking, Ibrutinib.
Multi-centre feasibility study of Ibrutinib in two separate cohorts of patients; i) treatment naïve and ii) relapsed/refractory CLL
The original IcICLLe Trial completed recruitment but now an amendment has opened to study the combination of Ibrutinib plus Obinutuzumab and is due to close at the end of April 2017.
This trial is sponsored by the University of Birmingham and run by the Bloodwise-funded Trials Acceleration Programme
A proposed Phase 2, Randomised study of CHOP-R in Combination with Acalabrutinib (ACP 196) followed by Acalabrutinib maintenance compared to CHOP-R followed by Acalabrutinib at disease progression for patients with newly diagnosed Richter’s Syndrome.
The following pharmaceutical company trials are supported by the NCRI for recruitment in the UK.
A phase 3, Randomised study to evaluate the combination of Ublituximab (a monoclonal antibody that targets CD20 on B Lymphocytes) and TGR 1202 (a novel PI3K delta inhibitor) compared to Obinutuzumab and Chlorambucil)