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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myeloma Non Hodgkin's Lymphoma Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Up to 900 participants will be recruited to the RATIONAL-PT, including up to 300 per domain. The aim of the platform is to determine optimal supportive care interventions for patients with haematological malignancies. The primary outcome for the platform is 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. Data from each domain will contribute to the primary analysis.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.

Study Groups

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Arm A: Low dose (IgRT) immunoglobulin replacement therapy

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.

Group Type OTHER

Immune Globulin Intravenous

Intervention Type BIOLOGICAL

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).

Arm B: Usual dose

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.

Group Type OTHER

Immune Globulin Intravenous

Intervention Type BIOLOGICAL

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).

Interventions

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Immune Globulin Intravenous

Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).

Intervention Type BIOLOGICAL

Other Intervention Names

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IVIG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No