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

RECRUITINGPhase 2/3Sponsored by Monash University
Actively Recruiting
PhasePhase 2/3
SponsorMonash University
Started2025-05-06
Est. completion2027-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07202052

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

CancerLeukemiaMyelomaNon-Hodgkin's Lymphoma

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