Antibiotics versus immunoglobulin to prevent infections in people with blood cancers
Official title: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)
Run by Monash University · NCT07202065 · Data updated 2026-11-12
This trial tests whether taking preventive antibiotics instead of regular IV immunoglobulin can prevent infections in people with myeloma, non-Hodgkin lymphoma, or leukemia.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Monash University Academic / other |
| Locations | 3 sites (Adelaide, South Australia and 2 other locations) |
| Status | Recruiting |
| Started | April 28, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07202065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with myeloma, non-Hodgkin lymphoma, or leukemia who have received standard-dose IVIg for at least six consecutive months and whose treating clinician believes they cannot currently stop Ig are the intended participants.
✕Probably not a fit
Patients who have had or plan to have allogeneic stem cell transplant, recent major infection, prior splenectomy, known bronchiectasis, or other reasons the treating team deems unsafe are excluded and unlikely to benefit from this domain.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This domain of an adaptive platform compares prophylactic antibiotics with ongoing intravenous immunoglobulin (IVIg) replacement to prevent bacterial infections in patients with blood cancers. The platform design lets researchers run multiple comparisons at once, adapt allocations based on incoming results, and add new questions during the trial. Participants are those already receiving standard-dose IVIg for at least six months who are not considered suitable to stop Ig by their treating clinician. Key outcomes include infection rates, safety, and healthcare use such as hospital admissions and antibiotic courses.
Why it matters
Potential benefit: If successful, the approach could allow some patients to avoid regular IVIg infusions while keeping similar protection against infections, reducing clinic visits and treatment burden.
How similar studies have gone: While prophylactic antibiotics and immunoglobulin each have evidence for reducing infections in immunodeficient patients, directly substituting antibiotics for regular IVIg in this patient group within an adaptive platform is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months. 2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator. Exclusion Criteria: 1. Prior or planned allogeneic haematopoietic stem cell transplantation. 2. Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment. 3. Previous splenectomy. 4. Known history of bronchiectasis. 5. Previous participation in this domain. 6. Treating team deems enrolment in the domain is not in the best interest of the patient.
Where it's running
-
Royal Adelaide Hospital
Adelaide, South Australia, Australia Recruiting -
Austin Hospital
Melbourne, Victoria, Australia Recruiting -
Northern Health
Melbourne, Victoria, Australia Recruiting
Study contacts
- Principal investigator: Zoe McQuilten, Professor — Monash University
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Stopping immunoglobulin replacement with or without antibiotics to prevent infections in blood cancer patients
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Comparing antibiotics and immunoglobulin to prevent infections in blood cancers
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.