UK CLL Trials Portfolio as of July 2017.

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:

 

Patient Condition

Currently Open Trials

Future Planned Trials

Patients considered fit for FCR

(previously untreated)

CLL10 FLAIR Phase III trial

(FCR vs Ibrutinib + Rituximab vs Ibrutinib + Venetoclax vs Ibrutinib monotherapy)

 

 

Patients considered unfit for FCR

(previously untreated)

CLL9 RiAltO (Chlorambucil+Ofatumamab vs Bendamustin+Ofatumamab

 

Unity Trial - UTX-TGR-304 (Ublituximab [TG1101] + TGR 1202 vs Obinutuzumab + Chlorambucil)

 

17p deleted CLL (previously untreated)

--

Clarity Amendment

 

BGB-3111-304_CLL_Phase_3

(BGB-3111 vs Chlorambucil+Obinutuzumab)

Consolidation to achieve MRD -ve

--

--

Stage A CLL

--

--

Richter’s Transformation

--

STELLAR Acalabrutinib ACP-196 Bloodwise TAP trial

Relapsed CLL

Acerta ACE-CL-006: Acalabrutinib (ACP-196) vs Ibrutinib

 

Bloodwise TAP (CALiBRe [Idelalisib]) recruiting on hold

 

Bloodwise IcICLLe amendment (Ibrutinib +

Obinutuzumab)

 

Bloodwise CLARITY (Ibrutinib + Venetoclax)

 

Unity Trial UTX-TGR-304 Ublituximab [TG1101] + TGR 1202 vs Obinutuzumab + Chlorambucil)

 

--

Refractory CLL

Acerta ACE-CL-006: Acalabrutinib (ACP-196) vs Ibrutinib

 

Bloodwise TAP CALiBRe (Idelalisib) recruiting on hold

 

Bloodwise IcICLLe amendment (Ibrutinib +

Obinutuzumab)

 

Bloodwise CLARITY (Ibrutinib + Venetoclax)

--

11q del CLL

--

--

Relapsed 17p deleted CLL

Acerta ACE-CL-006: Acalabrutinib (ACP-196) vs Ibrutinib

 

Bloodwise TAP CALiBRe (Idelalisib) recruiting on hold

 

Bloodwise IcICLLe amendment (Ibrutinib + Obinutuzumab)

 

Bloodwise CLARITY (Ibrutinib + Venetoclax)

--

 

 

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)

Cancer Research UK 

UK CRM 

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.

Leeds 

Cancer Research UK 

UK CRN 

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.

The trial is sponsored by the University of Birmingham and run by the Bloodwise-funded Trials Acceleration Programme

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.

This trial is sponsored by the University of Birmingham and run by the Bloodwise-funded Trials Acceleration Programme

Bloodwise IcICLLe

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

STELLAR:

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.

See Also:

NIHR UK Clinical Trials Gateway 

Cancer Research UK 

INDUSTRY TRIALS

The following pharmaceutical company trials are supported by the NCRI for recruitment in the UK.

Acerta ACE-CL-006

A trial of Acalabrutinib (ACP-196), a new Bruton Tyrosine Kinase inhibitor, compared with Ibrutinib in relapsed or refractory CLL.

UNITY UTX-TGR-304

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)

GWB

July 2017