None listed
Conditions
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. Who is it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: 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. Depending on the domain you are participating in, you may be assigned to a study treatment by chance (randomly). Following randomisation (if applicable), you will be asked to complete your Day 1 assessments. If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (immunoglobulins, antibiotics or none). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know which treatment to prescribe to try to prevent serious infections.
Interventions
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.
Initially the researchers will be investigating how safe and effective immunoglobulin replacement therapy is compared to oral antibiotics to prevent serious infections in pa
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. Initially the researchers will be investigating how safe and effective immunoglobulin replacement therapy is compared to oral antibiotics to prevent serious infections in patients with blood cancers, and also comparing different approaches to immunoglobulin dosing to determine the best dose of immunoglobulin for infection prevention. Further comparisons may be added to the platform. Each comparison will be included as a sub-component, or ‘domain’, of the RATIONAL-PT. The treatments used in each domain may not be the same. Examples of treatments may include intravenous immunoglobulin, sub-cutaneous immunoglobulin and oral antibiotics. The duration of the trial-related treatment is 12 months in each domain. Investigational products to be trialled will be considered and approved by the International Trial Steering Committee (ITSC). The ITSC will include members with experience and knowledge of the trial design, domain-specific expertise and regional-specific expertise. Participants who have enrolled in and completed one domain may be invited to participate in another domain appropriate to their changed status. Each domain has its own domain-specific selection criteria, therefore eligibility for one domain does not imply eligibility for other domains. The anticipated duration of the trial is 5 years. However, due to the adaptive platform design, trial duration may be extended in future with the addition of new domains.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed