Summary
You may be eligible for this study if you are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have received immunoglobulin (Ig) treatment for over 6 months.
Eligible participants will be randomly allocated to one of three treatment groups:
- To stop Ig, and be given oral antibiotics to take every day
- To stop Ig, and be given oral antibiotics to keep at home and use only if infection symptoms occur
- To continue receiving their usual Ig treatment.
The duration of each treatment is 12 months.
Over the course of the 13 month study participation period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period.
Types of assessments and data collected will include: medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.
It is hoped that this study will confirm if Ig used to prevent infections can be safely stopped, and if oral antibiotics should be given as an alternative, thus improving treatment for people with blood cancer.