NCT05678621 Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension
| NCT ID | NCT05678621 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Monash University |
| Condition | Haematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2022-11-30 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 SCIg) - this is the usual care group (ARM C) The duration of each treatment is for 12 months from study entry. Participants will be asked to attend a screening/baseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups. Once randomised, active participation in the study will last for 13 months. During this period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period. Types of assessments and data collected will include: Medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.
Eligibility 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.
Contact & Investigator
Prof Erica Wood
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT05678621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Haematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05678621 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05678621 currently recruiting?
Yes, NCT05678621 is actively recruiting participants. Contact the research team at zoe.mcquilten@monash.edu for enrollment information.
Where is the NCT05678621 trial being conducted?
This trial is being conducted at Garran, Australia, Concord, Australia, St Leonards, Australia, Clayton, Australia and 3 additional locations.
Who is sponsoring the NCT05678621 clinical trial?
NCT05678621 is sponsored by Monash University. The principal investigator is Prof Erica Wood at Monash University. The trial plans to enroll 300 participants.