Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Monash University
Registry number NCT05678621
Started 30 November 2022 Today 16 October 2026 Estimated completion 1 April 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Canberra Hospital Garran ACT Not yet recruiting
Concord Hospital Concord NSW Recruiting
Royal North Shore St Leonards NSW Not yet recruiting
Monash Medical Centre Clayton VIC Recruiting
Austin Hospital Heidelberg VIC Recruiting
The Alfred Hospital Melbourne VIC Recruiting
Sunshine Hospital St Albans VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 300

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 30 November 2022
Estimated completion 1 April 2027
Registry last updated 19 April 2024
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 19 April 2024.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.