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

NCT07202065 | Recruiting Phase 2 DMC

• 1 other identifier: TRU-RPT-22 Dose-Ig
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Myeloma; Non Hodgkin's Lymphoma; Leukemia

Keywords

immunoglobulin; antibiotics; myeloma; leukaemia; lymphoma; non Hodgkins; infection; infections; blood; cancer; haematology

Outcome Measures

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.

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

Secondary Outcomes (14)

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

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

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

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

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

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

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

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

• Number of microbiologically documented infections from randomisation to 12 months.

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

Study Arms (2)

Arm A: Low dose (IgRT) immunoglobulin replacement therapy

OTHER

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.

Biological: Immune Globulin Intravenous

Arm B: Usual dose

OTHER

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.

Biological: Immune Globulin Intravenous

Interventions

Immune Globulin Intravenous BIOLOGICAL

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

Also known as: IVIG

Arm A: Low dose (IgRT) immunoglobulin replacement therapy; Arm B: Usual dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previous participation in this domain.
• Treating team deems enrolment in the domain is not in the best interest of the patient.

Sponsors & Collaborators

• Monash University: lead

Study Sites (3)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Austin Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Northern Health

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Links

• Study Website

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Leukemia; Lymphoma; Infections; Neoplasms

Interventions

gamma-Globulins; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies

Study Officials

• Zoe McQuilten, Professor

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 1, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)