Antibiotics versus immunoglobulin to prevent infections in people with blood cancers
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)
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 |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 3 sites (Adelaide, South Australia and 2 other locations) |
| Trial ID | NCT07202065 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Adelaide, South Australia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.