Testing if stopping immunoglobulin therapy and using antibiotics can prevent infections in blood cancer patients
A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies.
This study is testing if blood cancer patients can safely stop their immunoglobulin therapy after six months and use antibiotics instead to prevent infections.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 7 sites (Garran, Australian Capital Territory and 6 other locations) |
| Trial ID | NCT05678621 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether patients with blood cancers, who have been receiving immunoglobulin therapy to prevent infections, can safely stop this therapy after six months and instead take oral antibiotics. Participants will be randomly assigned to one of three groups: one group will stop immunoglobulin and take daily antibiotics, another will stop immunoglobulin and take antibiotics only when symptoms arise, and the third group will continue with immunoglobulin therapy as usual. The study will last for 12 months and focuses on patients with acquired hypogammaglobulinaemia due to haematological malignancies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic lymphocytic leukaemia, multiple myeloma, or non-Hodgkin lymphoma who have been on immunoglobulin therapy for more than six months.
Not a fit: Patients who have had recent major infections or are currently receiving daily antibiotic prophylaxis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for immunoglobulin therapy while still effectively preventing serious infections in patients with blood cancers.
How similar studies have performed: While similar approaches have been explored, this specific method of transitioning from immunoglobulin therapy to oral antibiotics in this patient population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Garran, Australian Capital Territory and 6 other locations
- Canberra Hospital — Garran, Australian Capital Territory, Australia (Not_yet_recruiting)
- Concord Hospital — Concord, New South Wales, Australia (Recruiting)
- Royal North Shore — St Leonards, New South Wales, Australia (Not_yet_recruiting)
- Monash Medical Centre — Clayton, Victoria, Australia (Recruiting)
- Austin Hospital — Heidelberg, Victoria, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- Sunshine Hospital — St Albans, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Prof Erica Wood — Monash University
- Study coordinator: Prof Zoe McQuilten
- Email: zoe.mcquilten@monash.edu
- Phone: +61 3 9903 0379
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.