Myeloma, Non Hodgkin's Lymphoma, Leukemia
Conditions
Keywords
immunoglobulin, antibiotics, myeloma, leukaemia, lymphoma, non Hodgkins, infection, infections, blood, cancer, haematology
Brief summary
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.
Detailed description
This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.
Interventions
BIOLOGICALImmune Globulin Intravenous
Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week).
Sponsors
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.
Intervention model description
Up to 900 participants will be recruited to the RATIONAL-PT, including up to 300 per domain. The aim of the platform is to determine optimal supportive care interventions for patients with haematological malignancies. The primary outcome for the platform is 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 from each domain will contribute to the primary analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months. 2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Exclusion criteria
1. Prior or planned allogeneic haematopoietic stem cell transplantation. 2. Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment. 3. Previous splenectomy. 4. Known history of bronchiectasis. 5. Previous participation in this domain. 6. Treating team deems enrolment in the domain is not in the best interest of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS). | 12 months following randomisation (or, in domains with a single treatment arm, time from registration) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. | 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. |
| Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. | 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. |
| Occurrence of one or more microbiologically documented infections from randomisation to 12 months. | 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. |
| Number of microbiologically documented infections from randomisation to 12 months. | 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. |
| All-cause mortality at 12 months. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | All-cause mortality at 12 months. |
| Infection-related mortality at 12 months. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | Infection-related mortality at 12 months. |
| Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months. |
| Occurrence of one or more treatment-related adverse events. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | Occurrence of one or more treatment-related adverse events. |
| Number of treatment-related adverse events. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | Number of treatment-related adverse events. |
| Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months. | 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. |
| 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. | 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. |
| Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire. | Randomisation, Month 3, Month 6, Month 9 and Month 12 | Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire. |
| Costs associated with allocated treatment arm and infections during study. | 12 months following randomisation (or, in domains with a single treatment arm, time from registration). | Costs of infections and trial interventions will be estimated based on trial treatment and adverse event data within the hospital medical record, as well as linked data obtained from the Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Register (AIR). Data from the quality of life questionnaires will be used to calculate quality adjusted life years. |
| Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months. | 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. |
Countries
Australia
Outcome results
None listed