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

Sponsor
Monash University
Study ID
NCT07202052
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous immunoglobulin — BIOLOGICAL
    (IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.
  • Trimethoprim / Sulfamethoxazole — DRUG
    Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
  • Amoxicillin clavulanic acid — DRUG
    Patients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for participants with hypersensitivity.
  • Intravenous immunoglobulin (IVIG) — BIOLOGICAL
    Arm A: Low dose (IgRT) immunoglobulin replacement therapy: Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum IgG levels is required. Arm B: Usual dose: Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range.

Study Details

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 Dates

First listed
Oct 1, 2025
Start date
May 6, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration) ]

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