Comparing antibiotics and immunoglobulin to prevent infections in blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

RATIONAL-PT is an adaptive platform trial that compares different infection-prevention strategies, including intravenous immunoglobulin and oral antibiotic prophylaxis, in adults with haematological malignancies. Eligible participants have multiple myeloma, non-Hodgkin lymphoma, or chronic lymphocytic leukaemia with low IgG or a history of recurrent or severe infections and are randomized into different prevention domains. The adaptive design allows multiple approaches to be compared simultaneously, interim analyses to refine or stop arms, and the addition of new questions over time. Key outcomes include infection rates, serious infection-related hospitalizations, and overall healthcare use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
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

Exclusion Criteria:

1\. Treating team deems enrolment in the study is not in the best interests of the patient.

Where it's running

• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• Austin Hospital
  Melbourne, Victoria, Australia Recruiting
• Northern Health
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Zoe McQuilten, Professor — Monash University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.