There are currently 5 clinical trials underway at Anthony Nolan
1. Pre-DLI lymphoreduction trial
Donor leukocyte infusions (DLI) are given to patients who have mixed chimerism after transplant, or to those who have disease relapse. DLI are not always successful. The aim of this study is to investigate whether reducing the lymphocyte count before the DLI helps patients to respond better to the DLI. We are studying both clinical and research parameters to assess response.
Type of study: Phase II, investigator led, 2 centres
Number of patients: 18 (16 recruited)
Principal/Chief Investigator: Shaw
Sponsor: Institute of Cancer Research
Funding: No specific funding
Staff: Shaw/Tulpule (research laboratory analysis)
Outcomes: ASH abstract (poster presentation)
2. Cord Blood Transplant Immune reconstitution Study
The aim of this study is investigate the speed and diversity of recovery of all the different cells in the immune system after a cord blood transplant. This is important as it will help us to predict and treat the complications (especially infection) which are common after these type of transplants.
Type of study: Multicentre. Sample and data collection.
Number of patients: All cord blood transplant recipients in the UK (3 years). 150-200 patients.
Principal/Chief Investigator: Shaw, Madrigal, Navarette
Sponsor: Anthony Nolan/NHSBT
Funding: Anthony Nolan/NHSBT
Staff: Shaw/Madrigal/Tulpule/Ahyee
Outcomes: EBMT abstract (submitted)
3. Patient/donor project
The aim of this study is to understand the impact of genetic factors on the outcome and complications of stem cell transplantation. Samples are processed and stored in pairs with unique numbers (de-identified). We have developed a large and comprehensive biobank and performed extensive analysis both internally and as part of larger collaborations. We have extensive analysis of HLA and especially the clinical impact of HLA-DPB1. In addition we have studied other immune response genes and systems such as: KIR, NOD2/CARD15, TGF-beta, TNF-alpha, IL12, Caspase 8.
Type of study: Multicentre. Sample and data collection.
Number of patients: All UD transplant recipients in the UK receiving a transplant from an Anthony Nolan donor. Longstanding study (>10 years). >2000 pairs included to data.
Principal/Chief Investigator: Madrigal/Marsh/Shaw
Sponsor: Anthony Nolan
Funding: Anthony Nolan
Staff: Madrigal/Marsh/Shaw/ Mayor/Schellekens/Cooke
Outcomes: Numerous presentations and publications. Several PhDs. (see website)
4. Extracorporeal photopheresis in GVHD
The aim of this study is to investigate the impact of ECP in patients with GvHD using a fixed schedule and protocol for the withdrawal of immunosuppression.
Type of study: Single-centre, investigator lead, prospective study
Number of patients: All patients receiving ECP at St Thomas’s Hospital (2 years ~ 100)
Principal/Chief Investigator: Scarisbrick/Shaw/Dignan
Sponsor: Guys and St Thomas NHS Trust
Funding: Therakos (corporate grant)
Staff: Shaw/Madrigal/Dignan
Outcomes: ASH, EBMT abstract and publication (submitted)
5. GCSF Chromosomal study
The aim of this study is to investigate whether the use of GCSF may be associated with any damage to the chromosomes which may predispoe to leukaemia (as had been reported by one study). So far samples have been analysed from 50 normal people, 50 previous bone marrow donors and 50 previous PBSC donors. In this analysis there is no evidence of any increase in chromosomal abnormalities in donors who have received PBSC.
Type of study: retrospective/prospective, multicentre
Number of patients: 150
Principal/Chief Investigator: Madrigal/Navarette/Pamphilon/Goldman
Sponsor: UCL
Funding: Corporate
Staff: Madrigal/Ahyee
Outcomes: EBMT presentation and publication (submitted)