RecruitingPhase 2Phase 3NCT07202091

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)

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

Sponsor

Monash University

Enrollment

900 participants

Start Date

May 6, 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 it is safe to stop immunoglobulin (antibody) replacement therapy in blood cancer patients who have been receiving it to prevent infections. Some patients may no longer need it, and this study aims to find out whether stopping therapy leads to more infections. **You may be eligible if...** - You have been receiving immunoglobulin replacement therapy (intravenous or under the skin) for at least 6 months to prevent bacterial infections - Your doctor thinks you are a candidate to try stopping the therapy - You are willing and able to comply with both treatment options in the trial **You may NOT be eligible if...** - You have had or plan to have a donor stem cell transplant - You have had a serious infection (grade 3 or higher) in the past 3 months, or you have an active infection - You are already taking antibiotics to prevent bacterial infections - You have had your spleen removed, or you have bronchiectasis 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.

DRUGAmoxycillin/clavulanic acid

Patients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical.

BIOLOGICALImmune Globulin Intravenous

Participants will continue treatment with their current Ig replacement schedule. Participants will receive monthly (every 4 weeks ± 1 week) intravenous immunoglobulin 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. For patients who have already had their Ig dose titrated to IgG trough level, they may continue on their current monthly dose of Ig replacement. 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.