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NCT07202052RecruitingPhase 2/3

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

A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)

Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
900 (estimated)
First submitted
24 Sept 2025
Start date
6 May 2025
Primary completion date
31 Mar 2027
Lead sponsor
Monash University
NCT number
NCT07202052

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 900
  • From 6 May 2025 to the primary completion date, 31 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 1\. Treating team deems enrolment in the study is not in the best interests of the patient.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Northern Health
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Austin Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.