Clinical Trials

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
Principal/Chief Investigator: Shaw
Sponsor: Institute of Cancer Research
Funding: Internal

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: AN/NHSBT
Funding: AN/NHSBT

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 ANT donor. Longstanding study (>10 years). >2000 pairs included to data.
Principal/Chief Investigator: Madrigal/Marsh/Shaw
Sponsor: AN
Funding: AN

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