Tests infection prevention strategies in people with blood cancers
Compares ways to prevent infection in adults with myeloma, leukemia or lymphoma.
Plain-language title generated from the registry record
Registry title: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
Key facts
- Where
- Adelaide and Melbourne, AustraliaSee the 3 sites
- Phase
- Phase 2/3
Where in Australia
- Royal Adelaide HospitalAdelaide, AustraliaTaking people
- Austin HospitalMelbourne, AustraliaTaking people
- Northern HealthMelbourne, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Monash University
- Trial code
- NCT07202091
- Record updated
- 7 October 2025
- Original description
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.Read full original descriptionShow less
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Stop-Ig)
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.
This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.
The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.
Inclusion: Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months; Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator; Patient is willing and able to comply with each of the treatment arms.
Exclusion: Prior or planned allogeneic haematopoietic stem cell transplantation; Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis); Previous splenectomy; Previous participation in this domain; Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring systemic antimicrobial treatment; Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection; Severe renal impairment (estimated or measured creatinine clearance of < 30 mL/min); Intolerance of all trial antibiotic options in either arm A or arm B; Pregnant or breastfeeding; Treating team deems enrolment in the domain is not in the best interests of the patient.