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

Monash University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Non Hodgkin's Lymphoma; Myeloma; Leukemia

Treatments: Biological: Immune Globulin Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT07202065

TRU-RPT-22 Dose-Ig

Details and patient eligibility

About

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.

Full description

This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.

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 systemic antimicrobial treatment.
3. Previous splenectomy.
4. Known history of bronchiectasis.
5. Previous participation in this domain.
6. Treating team deems enrolment in the domain is not in the best interest of the patient.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Arm A: Low dose (IgRT) immunoglobulin replacement therapy

Other group

Description:

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum (IgG) immunoglobulin G levels is required.

Treatment:

Biological: Immune Globulin Intravenous

Arm B: Usual dose

Other group

Description:

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum (IgG) immunoglobulin G reference range.

Treatment:

Biological: Immune Globulin Intravenous