Clinical Trials

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Clinical Trials: the application of Biomarker and Discovery processes to clinical bedside healthcare.

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decisionmaking.

The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.

Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. For safety purposes, clinical trials start with small groups of patients (early phase trials) to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach’s risks and benefits.

More information on clinical trials can be found in the FAQ section here.

 

There are currently sixteen clinical trials in epigenetics in development across VEG sites in a variety of haematological malignancies including leukaemia, lymphoma and myeloma.

Short Title Description of Clinical Trials open to recruitment Investigator
BET Inhibitor A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with relapsed, refractory hematologic malignancies M Dawson
M Dickinson
Oral aza +len+dex MM Phase Ib trial of continuous oral azacitidine in combination with lenalidomide and dexamethasone for myeloma patients with relapsed and/or refractory disease who have failed a prior lenalidomide containing regimen A Spencer
Panobinostat MM post transplant A 2-stage Phase II study of panobinostat in myeloma patients with < VGPR following HD chemotherapy conditioned ASCT A Spencer
Pom_Dex_MM A prospective randomised Phase II study of single agent pomalidomide maintenance versus combination pomalidomide and low dose dexamethasone maintenance following induction with the combination of pomalidomide and low dose dexamethasone in patients with relapsed and refractory myeloma previously treated with Lenalidomide A Spencer
POL1 inhib haem malig Phase I, pharmacokinetic, and pharmacodynamic study of CX-5461 in patients with advanced haematological malignancies HM Prince
CDKi portfolio in AML A portfolio of iterative clinical trials of a CDK inhibitor with possible combinations of AZA/ARA-C/lenalidomide/HDACi in high risk MDS and AML D Ritchie
M Dawson
M Dickinson
J Shortt
EZH2i FL Phase II study of EZH2 inhibitor in follicular lymphoma HM Prince

 

Short Title Description of Clinical Trials under development Investigator
PhII RId Phase II study of lenalidomide (Revlimid) and romidepsin (Istodax) for relapsed /refractory Hodgkin lymphoma, mature T-cell lymphoma and multiple myeloma M Dickinson
Brentux+len PTCL A pilot safety study of brentuximab vedotin and lenalidomide in patients with Hodgkin lymphoma and CD30+ T-cell lymphoma. M Dickinson
HM Prince
DinaSaRR A phase 2 study examining the efficacy and safety of dinaciclib salvage in patients with Relapsed/Refractory DLBCL J Shortt
S Opat
Len_ASCT_MM Lenalidomide consolidation post allogeneic stem cell transplant for patients with high risk multiple myeloma failing to achieve stringent CR A Spencer
Pom_Dex_MM2 A 2-stage Phase II study of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated with lenalidomide maintenance post Autologous Stem Cell Transplant A Spencer
Thal_Dex_MM A Phase III trial of thalidomide dexamethasone consolidation versus Thalidomide-dexamethasone-MLN9708 consolidation with ongoing MLN9708 maintenance therapy for transplant eligible multiple myeloma patients undergoing a single ASCT as part of front-line therapy (ALLG MM18) A Spencer
Car_Thal_Dex_MM A multi-centre single arm study of carfilzomib-thalidomide-dexamethasone (TD-K) for newly diagnosed transplant-eligible multiple myeloma patients refractory to initial bortezomib-based induction therapy (ALLG MM17) A Spencer
MEK_Pan_MM2 A single centre 3-stage Phase Ib/II study of MEK162 and panobinostat in patients with poor risk refractory and/or relapsed multiple myeloma A Spencer

 

Short Title Description of Clinical Trials closed to recruitment Publication (Click to access)
Pan_Aza_MDS A Phase Ib/II Clinical Evaluation of The Safety and Efficacy of Combining Panobinostat With 5-Azacytidine In Patients With High-Risk MDS or AML That Are Unsuitable For Standard Induction Chemotherapy A Spencer
mTOR_Aza_AML A Phase Ib/II clinical evaluation of the safety of combining the mTOR inhibitor Everolimus with 5-azacytidine in AML A Spencer
Aza_Len_AML A phase Ib/II clinical evaluation of maintenance 5-Azacytidine combined with Lenalidomide after salvage cytoreductive chemotherapy for relapsed AML A Spencer
Len_Pred_ASCT A Phase II study of lenalidomide and prednisolone as Post-ASCT maintenance therapy for patients with multiple myeloma incorporating residual disease monitoring A Spencer
VCA1 Panobinostat in CTCL. A single arm phase II trial to explore gene expression profiles and immune responses to panobinostat (LBH589) in mature B and T cell lymphoproliferative disorders. <Blank>
VCA2 (Aza-E) A single arm pilot study of 5-azacitidine in myelodysplastic syndrome / acute myeloid leukaemia, with eltrombopag support for thrombocytopenia. Dickinson 2014
RAD001-5aza AML A Phase Ib/II Clinical Evaluation Of The Safety Of Combining the mTOR inhibitor Everolimus With 5-Azacitidine In AML. Wei 2011
ALLG MDS3 A Phase I/II trial to determine safety & efficacy of combination therapy with 5-azacitidine (Vidaza) and Thalidomide in patients with Myelodysplastic Syndromes (MDS) Kenealy 2009
ALLG MDS4 A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML). Kenealy 2013
LBH-aza AML/MDS A phase Ib/II clinical evaluation of the safety and efficacy of combining panobinostat with 5-azacitidine in patients with high-risk MDS or AML that are unsuitable for standard induction chemotherapy. Spencer 2014
aza-lenmaint AML A phase Ib/II clinical evaluation of maintenance azacitidine combined with lenalidomide after cytoreductive chemotherapy for AML. Wei 2012
(BCell-I131) NHL Panobin+RIT A Phase I/II trial to determine the Safety, Toxicity and Efficacy of Iodine-131-Rituximab and the Histone Deacetylase Inhibitor panobinostat in Relapsed and Refractory Indolent B-cell Lymphoma Bishton
(VCA13) VEIL Vorin+eltrom NHL A pilot study of oral vorinostat plus oral eltrombopag support in patients with cutaneous T-cell lymphoma <blank>