Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT) Domain Addendum - Dosing Immunoglobulin (Dose-Ig)

Phase 2

• Conditions: haematological malignancy; hypogammaglobulinemia; Cancer - Myeloma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12624000962538
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients are eligible for the Dose-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Dose-Ig domain.

RATIONAL-PT inclusion criteria:
1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL)
3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG<4g/L (excluding paraprotein)
4. Life expectancy > 12 months
5. Able to give informed consent

Dose-Ig domain 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

Patients are eligible for the Dose-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Dose-Ig domain.

RATIONAL-PT exclusion criteria:
1. Treating team deems enrolment in the study is not in the best interests of the patient

Dose-Ig domain 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Nb: This is a RATIONAL-PT core outcome measure.[Data collected from medical records will inform this outcome measure 12 months following randomisation]