Stopping immunoglobulin replacement with or without antibiotics to prevent infections in blood cancer patients
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Stop-Ig)
This trial tests if stopping immunoglobulin replacement, with or without daily preventive antibiotics, is safe and keeps infections low in people with myeloma, leukemia, or non-Hodgkin's lymphoma who have been on Ig therapy.
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 | NCT07202091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with myeloma, leukemia, or non-Hodgkin's lymphoma who have received IV or subcutaneous Ig replacement for at least six consecutive months and whose treating clinician agrees they are eligible to try stopping Ig.
Not a fit: Patients with recent major infections, current active infection, planned allogeneic stem cell transplant, or those already on systemic antibiotic prophylaxis are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, some patients may be able to stop long-term immunoglobulin replacement, reducing injections and healthcare use while maintaining a low risk of infection.
How similar studies have performed: Smaller studies and clinical experience indicate some selected patients can stop Ig safely, but randomized data directly comparing stopping Ig with or without antibiotic prophylaxis are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.