Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

Recruiting now · Phase 2/Phase 3

Conditions studied: Myeloma, Non-Hodgkin's Lymphoma, Leukemia

In brief

This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.

Key facts

Study ID

NCT07202052

Run by

Monash University

People needed

900

Starts

2025-05-06

Expected to finish

2027-03-31

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged greater than or equal to 18 years of age
• Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
• 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)
• Life expectancy > 12 months
• Able to give informed consent

You may not qualify if…

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

Where it is running

• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Austin Hospital — Melbourne, Victoria, Australia (enrolling)
• Northern Health — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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