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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMonash University
NCT05678621 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections. Patients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months. Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: * Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A) * Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B) * Continue receiving immunoglobulin (IVIg or

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged greater than or equal to 18 years of age 2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL). 3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months. 4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator. 5. Life expectancy greater than 12 months. 6. Able to give informed consent, and 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 antimicrobial treatment. 3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and Pneumocystis jirovecii pneumonia (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 less than 30 mL/min). 8. Previous splenectomy. 9. Previous participation in this trial. 10. Treating team deems enrolment in the study is not in the best interests of the patient.
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What it tests

  • trimethoprim-sulfamethoxazole (co-trimoxazole)
  • amoxycillin/clavulanic acid and ciprofloxacin
  • Immunoglobulins
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Where

7 sites
Canberra Hospital
Garran, Australia
Concord Hospital
Concord, Australia
Royal North Shore
St Leonards, Australia
Monash Medical Centre
Clayton, Australia
Austin Hospital
Heidelberg, Australia
The Alfred Hospital
Melbourne, Australia
Sunshine Hospital
St Albans, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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