RecruitingPhase 2Phase 3NCT07202065

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)


Sponsor

Monash University

Enrollment

900 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether patients with blood cancers who are already receiving standard-dose immunoglobulin (antibody) replacement therapy to prevent infections can safely receive a different (potentially lower or adjusted) dose. The goal is to find the optimal dose that keeps patients protected while potentially reducing side effects and costs. **You may be eligible if...** - You have been receiving standard-dose intravenous immunoglobulin (IVIg) for at least 6 consecutive months to prevent bacterial infections - Your doctor does not think you are ready to try stopping immunoglobulin therapy altogether **You may NOT be eligible if...** - You have had or plan to have a stem cell transplant from a donor - You have had a major infection (grade 3 or higher) in the past 3 months, or you have an active infection - You have had your spleen removed, or you have a history of bronchiectasis (chronic lung disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALImmune Globulin Intravenous

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).


Locations(3)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Hospital

Melbourne, Victoria, Australia

Northern Health

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07202065


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