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

Phase 2

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

• Registration Number: ACTRN12624000964516
• 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 Start-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Start-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

Start-Ig domain inclusion criteria:
None.

Exclusion Criteria

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

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

Start-Ig domain exclusion criteria:
1. Prior or planned allogeneic haematopoietic stem cell transplantation.
2. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and Pneumocystis jirovecii Pneumonia (PJP) prophylaxis).
3. Received immunoglobulin replacement in the preceding three months.
4. Objection to receiving immunoglobulin products.
5. Known history of IgA deficiency with anti-IgA.
6. History of severe allergy to immunoglobulin products.
7. Current active infection requiring systemic antibiotics.
8. Allergy or intolerance of all domain antibiotic options.
9. Pregnant or breastfeeding.
10. Severe renal impairment (estimated or measured creatinine clearance of < 30 mL/min).
11. Previous splenectomy.
12. Previous participation in this domain.
13. 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]