NCT07202052 Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
| NCT ID | NCT07202052 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Monash University |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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.