About this trial

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.

This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.

The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.

Patient is not 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 systemic antimicrobial treatment.

Previous splenectomy.

Known history of bronchiectasis.

Trial design

Design model

Parallel

Treatments tested in this trial

Immune Globulin Intravenous
Biological/Vaccine
Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).

Treatment groups

900 Participants

are divided into 2 treatment groups

Group A: Arm A: Low dose (IgRT) immunoglobulin replacement therapyOther 1 intervention

Group B: Arm B: Usual doseOther 1 intervention

Trial outcomes

Primary outcomes

1

Event-free survival (EFS).

Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) 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 randomisation (or, in domains with a single treatment arm, time from registration)

Secondary outcomes

1

Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.

Time frame

12 months following randomisation (or, in domains with a single treatment arm, time from registration).

2

Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.

Time frame

12 months following randomisation (or, in domains with a single treatment arm, time from registration).

3

Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.

Time frame

12 months following randomisation (or, in domains with a single treatment arm, time from registration).

4

Occurrence of one or more microbiologically documented infections from randomisation to 12 months.

Time frame

12 months following randomisation (or, in domains with a single treatment arm, time from registration).

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts