CLL Support Association
CLL Trials Portfolio
The following is a review of the CLL Trials open for recruitment in the as of July 2015.
The trials are grouped in relation to patient condition:
Patient Condition / Currently Open Trials / Future Planned TrialsPatients considered fit for FCR
(previously untreated) / FLAIR (CLL10) Phase III trial
(Ibrutinib + Rituximab vs FCR)
LLR TAP CALiBRe (Idelalisib Monotherapy) / FLAIR Amendment
(still in discussion regarding adding another chemotherapy-free arm)
Patients considered unfit for FCR
(previously untreated) / CLL9 RiAltO (Chlorambucil+Ofatumamab vs Bendamustin+Ofatumamab and +/- Idelalisib or placebo)
LLR TAP CALiBRe (Idelalisib Monotherapy)
PCYC-1130 (Chlorambucil + Obinutuzumab vs Ibrutinib + Obinutuzumab) / ACERTA ACE-CL-007
(ACP-196+obinutuzumab vs Chlorambucil + Obinutuzumab)
17p deleted CLL (previously untreated) / Gilead CLL 312-0133 Study (Idelalisb + Rituximab in 17P deleted front line)
CLL210 (OfaDexRev)
Consolidation to achieve MRD -ve / CLL 8 GALACTIC (Obinutuzumab consolidation for MRD positive patients)
Stage A CLL / -
Richter’s Transformation / NCRN 3130: Acerta ACE-CL-001: Phase 1 of ACP-196 in CLL
Relapsed CLL / CLL 212 COSMIC
LLR ICiCLLe amendment (Ibrutinib + Obinutuzumab) to open July 2015
LLR TAP CALiBRe (Idelalisib monotherapy)
Genentech: Randomised Phase III study in relapsed, refractory CLL of GDC-0199 (ABT-199) + Rituximan compared with Bendamustine + Rituximab
NCRN 3130: Acerta ACE-CL-001: Phase 1 of ACP-196 in CLL / LLR CLARITY (formerly IcICLLe 3) (Ibrutinib + ABT 199)
Acerta ACE-CL-006: ACP-196 vs ibrutinib (for patients with 17p and/or 11q deletion only)
Refractory CLL / CLL210 (OfaDexRev)
LLR IcICLLe amendment (Ibrutinib + Obinutuzumab) (to open Aug 2015)
NCRN 460: GP28331 (GDC-0199 + Obinutuzumab)
LLR TAP CALiBRe (Idelalisib monotherapy)
NCRN 3130: Acerta ACE-CL-001: Phase 1 of ACP-196 in CLL / LLR CLARITY (formerly IcICLLe 3) (Ibrutinib + ABT 199)
Acerta ACE-CL-006: ACP-196 vs ibrutinib (for patients with 17p and/or 11q deletion only)
11q delCLL / CLL 210 (OfaDexRev)
LLR IcICLLe amendment (Ibrutinib + Obinutuzumab) (to open Aug 2015) / LLR CLARITY (formerly IcICLLe 3) (Ibrutinib + ABT 199)
Acerta ACE-CL-006: ACP-196 vs ibrutinib (for patients with 17p and/or 11q deletion only)
CLL 8 GALACTIC (was CLARET)
A phase III randomised trial originally to assess the use ofObinutuzumab [GA101] as consolidation therapy in patients with CLL who have responded to previous treatment but have not achieved MRD Negativity.
Patients are eligable if they have achieved a response to their first to third line therapy but remain MRD positive. (MRD testing will be performed at trial entry and MRD negative patients will be followed)
The trial is sponsored by the Leeds Teaching Hospitals. The drug was changed from Alemtuzumab (Campath) to Obinutuzumab [GA101] due to non availability of Alemtuzumab and reopenedin late 2014.
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.
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 is due to run until early 2016.
CLL 10 FLAIR
Phase III randomised trial to assess whether Ibrutinib+Rituximab 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. This randomisation will be 1:1 to either Ibrutinib+R or FCR. Previiously untreated patients are eligable if they are considered fit for FCR.
The trial is sponsored by the Leeds Teaching Hospitals.
CLL 210 (OfaDexRev)
A randomised phase II trial of Ofatumumab, Dexamethasone and Lenalidomide followed by Lenalidomide maintenance or no further treatment in patients with high risk CLL (17p deletion or refractory CLL).
Was CamDexRev but Alemtuzumab (Campath) was changed to Ofatumumab due to non availability of Alemtuzumab and has reopened.
This trial is jointly sponsored by the University of Liverpool, Royal Liverpool and Broadgreen University Hospitals NHS Trust
CLL 212 COSMIC
Phase II randomised trial to assess the rate of complete remission between a combination of Fludarabine and Cyclophosphamide (FC) plus Ofatumumab at a standard dose or FC plus Ofatumumab at a Mega dose in patients who are fit for Fludarabine based chemotherapy.
The sponsor is the Leeds Teaching Hospitals NHS Trust and the trial opened in 2012.
LLR TAP CALiBRePhase II Trial
A feasability study to investigate the mechanism of action of Idelalisib and the biological response to Idelalisib in treatment naive and in relapsed/refractory patients.
This trial is sponsored by the University of Birmingham.
INDUSTRY TRIALS
The following pharmaceutical company trials are supported by the NCRN for recruitment in the UK.
NCRN 460
This is a dose-finding study which will evaluate the safety and pharmacokinetics of GDC-0199/ABT-199, a Bcl 2 Inhibitor, administered in combination with Obinutuzumab/GA101, a monoclonal antibody, to patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia. The anticipated time on study treatment is 6 months.
NCRN 3130
A Phase I study evaluating the safety and efficacy of a new Bruton Tyrosine Kinase inhibitor, ACP-196, in patients who have:
1. relapsed or are refractory after two prior treatments or
2.for patients with 17p deletions if they have had one prior treatment or
3.for patients diagnosed with Richter's Syndrome.
PCYC-1130
A phase III study of Ibrutinib combined with Obinutuzumab versus Chlorambucil in combination with Obinutuzumab in patients with previously untreated chronic lymphocytic leukemia.
GileadCLL-312-0133
A study evaluating the efficacy and safety of Idelalisib (GS-1101) in combination with Rituximab in patients with previously untreated CLL with 17p Deletion.
Genentech Phase III Study
A randomized Phase III study to compare the efficacy of GDC-0199 plus Rituximab (GDC-0199+R) with Bendamustine plus Rituximab (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia.
GWB
July 2015