RATIONAL Platform Trial & 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 RATIONAL platform trial aims to address evidence gaps in Ig use and infection prevention in patients with blood cancer. This is examined through three domains - Start-Ig, Stop-Ig and Dose-Ig - each designed to examine a different question around the use of immunoglobulin replacement therapy, or prophylatic antibiotics for infection prevention.

The RATIONALISE trial forms one domain of the platform (Stop-Ig domain), and 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 RATIONAL platform trial and RATIONALISE trial are key studies 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 trials are managed by Monash University in partnership with the Australasian Leukaemia and Lymphoma Group (ALLG), and supported by an MRFF grant (RATIONAL platform trial) and NHMRC Clincial Trials and Cohort Studies grant (RATIONALISE) together with the Blood Synergy.

To find out more, visit rationalisetrial.com