Stopping immunoglobulin replacement with or without antibiotics to prevent infections in blood cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This adaptive platform trial randomizes adults with myeloma, leukemia, or non-Hodgkin's lymphoma who have been on Ig replacement for at least six months to different infection-prevention strategies, including continuing Ig, stopping Ig alone, or stopping Ig plus prophylactic antibiotics. The platform design allows multiple strategies to be compared within the same trial, lets researchers add new arms over time, and adapts allocation based on accumulating results. Key outcomes include infection rates, serious infections, and healthcare use such as hospital admissions and antibiotic use, with follow-up at participating Australian hospitals. Standard antibiotics used in the trial include trimethoprim‑sulfamethoxazole or amoxicillin‑clavulanic acid and Ig is given per local IV or SC practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
2. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
3. Patient is willing and able to comply with each of the treatment arms.

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. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
4. Intolerance of all trial antibiotic options in either arm A or arm B.
5. Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.
6. Pregnant or breastfeeding.
7. Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
8. Previous splenectomy.
9. Previous participation in this domain.
10. Treating team deems enrolment in the domain is not in the best interests 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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• Telehealth music therapy for cognitive difficulties in blood cancer survivors

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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.