Status:
RECRUITING
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)
Lead Sponsor:
Monash University
Conditions:
Myeloma
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. ...
Detailed Description
This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of stopping Ig replacement with or without prophylactic antibiotics compare to continuing Ig replacement.
Eligibility Criteria
Inclusion
- Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
- Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
- Patient is willing and able to comply with each of the treatment arms.
Exclusion
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring systemic antimicrobial treatment.
- Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
- Intolerance of all trial antibiotic options in either arm A or arm B.
- 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.
- Pregnant or breastfeeding.
- Severe renal impairment (estimated or measured creatinine clearance of \< 30 mL/min).
- Previous splenectomy.
- Previous participation in this domain.
- Treating team deems enrolment in the domain is not in the best interests of the patient.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07202091
Start Date
May 6 2025
End Date
March 31 2027
Last Update
October 7 2025
Active Locations (3)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Austin Hospital
Melbourne, Victoria, Australia, 3004
3
Northern Health
Melbourne, Victoria, Australia, 3004