Clinical trial Recruiting at 3 sites Phase2; Phase3 Interventional Ages 18 and up

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.

More Leukemia trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment900 (estimated)
SponsorMonash University
Academic / other
Locations3 sites (Adelaide, South Australia and 2 other locations)
StatusRecruiting
StartedApril 28, 2025
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedOctober 7, 2025
Trial IDNCT07202065 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.