The RATIONALISE Trial

Blood cancer patients can be at an increased risk of infection due to low levels of antibodies circulating in their blood. To reduce the likelihood of serious infection, patients are often administered immunoglobulin (Ig) made from donated plasma. The RATIONALISE trial aims to determine if Ig replacement therapy can be stopped when patients are free of major infection, and if oral antibiotics (taken prophylatically) are effective for ongoing infection management. It is a Phase II/III randomised controlled trial enrolling participants with chronic lymphocytic leukaemia (CLL), multiple myeloma (MM), or non-Hodgkin’s lymphoma (NHL) who have been receiving Ig replacement for more than six months.

The RATIONALISE trial is a key study in the Blood Synergy’s Immunoglobulin Use stream, and integral to our objective of ‘developing new evidence to inform immunoglobulin use, and improve management of infectious risks’. The trial is managed by Monash University in partnership with the Australasian Leukaemia and Lymphoma Group (ALLG), and supported by an NHMRC Clincial Trials and Cohort Studies grant together with the Blood Synergy.

To find out more about the trial and its sub-studies, visit rationalisetrial.com