Comparing antibiotics and immunoglobulin to prevent infections in blood cancers
A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)
This project tests whether immunoglobulin or antibiotic strategies better prevent infections in adults with blood cancers.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 3 sites (Adelaide, South Australia and 2 other locations) |
| Trial ID | NCT07202052 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a haematological malignancy such as CLL, multiple myeloma, or non-Hodgkin lymphoma who have low IgG or recurrent/severe infections and are eligible for immunoglobulin replacement are ideal candidates.
Not a fit: Patients without low IgG or recurrent infections, those with life expectancy under 12 months, or those whose treating team judges participation unsuitable are unlikely to benefit.
Why it matters
Potential benefit: If successful, the trial could reduce serious infections and hospital stays for patients with blood cancers.
How similar studies have performed: Previous trials of IVIG and antibiotic prophylaxis in blood-cancer patients have shown mixed benefits, so this approach is partly supported but not definitively established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Adelaide, South Australia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.