RecruitingPhase 2Phase 3NCT07202078

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

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

Sponsor

Monash University

Enrollment

900 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Leukemia Myeloma Non Hodgkin's Lymphoma

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 starting immunoglobulin (antibody) replacement therapy — given intravenously — can reduce serious infections in people with blood cancers who have low antibody levels but are not currently receiving this treatment. It is part of a larger platform trial studying the best way to prevent infections in blood cancer patients. **You may be eligible if...** - You have a blood cancer with low IgG antibody levels and a history of infections, and you are not yet receiving antibody replacement therapy - You have not had a donor stem cell transplant and do not have other conditions that exclude you **You may NOT be eligible if...** - You have had or plan to have a donor stem cell transplant - You are already on systemic antibiotics to prevent bacterial infections - You have received immunoglobulin in the past 3 months - You have a known allergy or severe reaction to immunoglobulin products - You are pregnant or breastfeeding - You have severe kidney disease (creatinine clearance below 30 mL/min) - You have had your spleen removed 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

DRUGTrimethoprim / Sulfamethoxazole

Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.

BIOLOGICALImmune Globulin Intravenous

IVIg every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.