PRO-DLI: A Phase II Prospective Trial of Prophylactic Donor Lymphocyte Infusions for the Prevention of Relapse post HSCT in patients with High Risk Myeloid Malignancy
Study design/summary: This is a 2 arm, phase II, multicentre, randomised prospective clinical trial in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) who are suitable for a reduced intensity stem cell transplant
Objectives: The primary objective of this study is to determine whether prophylactic donor lymphocyte infusions (DLI) delivered as part of the planned transplant schedule improves the disease free survival of patients with AML or MDS. There are also other objectives in addition to the primary one which include; overall survival; rate at which disease returns (relapse); incidence of acute and chronic graft versus host disease (GvHD); percentage of patients achieving a full number of donor cells; questionnaires about quality of life; freedom from immunosuppression drugs and incidence of complications from infections all at or during one year.
Centres: 11 IMPACT centres
Target Number of patients: 124 patients
Patient population: Patients with AML or MDS who are suitable to undergo a reduced intensity stem cell transplant
Sponsorship/Funding: ProDLI is Sponsored by King’s College Hospital NHS Foundation Trust. The trial management costs for the Pro-DLI trial are funded by a grant from Bloodwise to Dr Victoria Potter and the King’s College Clinical Trials Unit. The trial will be delivered by IMPACT funded research nurses at 11 IMPACT centres.
Trial Status: Open to recruitment
Trial contacts: Irene Chang (Trial Coordinator) – firstname.lastname@example.org
Adrienne Abioye (Trial Coordinator) – email@example.com
Start Date: November 2017
Duration: Approximately 3 years
If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you. A referral from your medical team would be required in order to consider you for treatment on a clinical trial.