Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged greater than or equal to 18 years of age
Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL).
Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months.
Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Disqualifiers
Prior or planned allogeneic haematopoietic stem cell transplantation.
Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment.
Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and Pneumocystis jirovecii pneumonia (PJP) prophylaxis).
Intolerance of all trial antibiotic options in either arm A or arm B.
Trial design
Design model
Parallel
Treatments tested in this trial
trimethoprim-sulfamethoxazole (co-trimoxazole)
DrugDoxycycline is an alternative for participants with hypersensitivity to co-trimoxazole.
amoxycillin/clavulanic acid and ciprofloxacin
Drugclindamycin is an alternative to amoxycillin/clavulanic acid for participants with hypersensitivity to penicillin.
Immunoglobulins
DrugIntravenous monthly immunoglobulin or subcutaneous weekly immunoglobulin
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: ARM A: Stop immunoglobulin (Ig) and commence prophylactic oral antibioticsExperimental treatment 1 intervention
Group B: ARM B: Stop immunoglobulin (without prophylactic antibiotics)Experimental treatment 1 intervention
Group C: ARM C: Continue immunoglobulinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Event-free survival (EFS), defined as time from randomisation until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.
Time frame
12 months following randomisationSecondary outcomes
1
Proportion of patients who develop at least 1 Grade 3 or higher infection(s) from randomisation to 12 months.
Time frame
12 months following randomisation2
Proportion of patients with one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) to 12 months.
Time frame
12 months following randomisation3
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) to 12 months. Data collected from medical records will inform this outcome measure.
Time frame
12 months following randomisation4
Proportion of patients with one or more microbiologically documented bacterial infections.
Time frame
12 months following randomisationSponsors and contacts
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Source ClinicalTrials.gov