A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Austin Hospital
RECRUITING
Melbourne
Northern Health
RECRUITING
Melbourne
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 900
Treatments
Other: Start Immunoglobulin
Patients eligible to start immunoglobulin are randomly assigned to:~* receive either prophylactic antibiotic~* or Ig replacement.
Other: Stop Immunoglobulin
Patients eligible to stop immunoglobulin are randomly assigned to:~* Stop Ig and take daily antibiotics~* Stop Ig and take antibiotics only when infections occur~* Continue Ig therapy
Other: Dose Immunoglobulin
Patients receiving IVIg are randomly assigned to:~* Continue with standard dose (0.4 g/kg)~* Switch to a lower dose (0.25 g/kg)
Related Therapeutic Areas
Sponsors
Leads: Monash University