Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous immunoglobulin, Trimethoprim / Sulfamethoxazole, Amoxicillin clavulanic acid, Intravenous immunoglobulin (IVIG).
- Who it may be relevant to
- Registry conditions: Myeloma, Non-Hodgkin's Lymphoma, Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)
Overview
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.
Detailed description
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.
This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.
The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.
Interventions
- Biological Intravenous immunoglobulin
(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 load - Drug Trimethoprim / Sulfamethoxazole
Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole. - Drug Amoxicillin clavulanic acid
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 partic - Biological Intravenous immunoglobulin (IVIG)
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.
Primary outcome measures
- Event-free survival (EFS) [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Secondary outcome measures (12)
- Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Occurrence of one or more microbiologically documented infections from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Number of microbiologically documented infections from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- All-cause mortality at 12 months [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Infection-related mortality at 12 months [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Occurrence of one or more treatment-related adverse events [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Number of treatment-related adverse events. [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
- Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months [Time frame: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
1\. Treating team deems enrolment in the study is not in the best interests of the patient.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Royal Adelaide Hospital — Adelaide
- Austin Hospital — Melbourne
- Northern Health — Melbourne
Identifiers
NCT: NCT07202052 · TRU-RPT-22 · TRU-RPT-22