Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
Phase 2
- Conditions
- haematological malignancyhypogammaglobulinemiaCancer - MyelomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12624000961549
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including CLL, MM or NHL
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
Additional eligibility criteria will apply for each domain of the RATIONAL Platform Trial.
Exclusion Criteria
1. Treating team deems enrolment in the study is not in the best interests of the patient
Additional eligibility criteria will apply for each domain of the RATIONAL Platform Trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival (EFS), defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.[Data collected from medical records will inform this outcome measure 12 months following randomisation in each domain (or, in domains with a single treatment arm, time from registration)]
- Secondary Outcome Measures
Name Time Method