Prophylatic and Pre-emptive DLI for myeloid malignancies (PRO-DLI)
Research type
Research Study
Full title
A Phase II Prospective Trial of Prophylactic Donor Lymphocyte Infusions for the Prevention of Relapse post HSCT in patients with High Risk Myeloid Malignancy
IRAS ID
203951
Contact name
Victoria Potter
Contact email
Sponsor organisation
Kings College Hospital NHS Foundation Trust
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndromes (MDS) are blood cancers for which a stem cell or bone marrow transplant is the best chance of cure. Lowering the intensity of the transplant protocol makes the transplant easier to tolerate with less side effects. Using certain drugs to remove some white blood cells decreases the risk that the donor cells will cause an adverse reaction against the person who receives the transplant. This reaction is known as graft versus host disease (GVHD). These improvements means that transplant is now an option for older patients and those with other medical problems. In this context, relapse of blood cancer after transplant is the main factor limiting transplant success. Current therapies fail to treat relapse; therefore it is important to try and prevent relapse. We have demonstrated success in this area with a research programme developing strategies based on using the immune system to prevent blood cancer recurrence. Our data demonstrates impressive rates of survival without relapse for patients receiving lymphocytes (white cells) from the original transplant donor (DLI) early post-transplant. Current published information on outcomes after DLI is limited in the bloods cancers AML and MDS, hence we propose a prospective clinical trial of prophylactic DLI for these conditions. This will enable clinicians to determine the best way of giving DLI. The aims are to assess the benefits of DLI and also how well patients are able to tolerate DLI. Alongside this we aim to assess the impact of DLI on the immune system and the influence of different disease characteristics on how well DLI is able to work. A planned approach to DLI administration will enable evaluation of factors influencing prevention of relapse, providing foundation for future translational and larger scale clinical studies.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0324
Date of REC Opinion
22 Aug 2016
REC opinion
Further Information Favourable Opinion