Summary
This research project uses an Adaptive Platform Design. This design allows 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.
To learn more about the domains of the RATIONAL-PT study, you can search for the following individual trial records:
- Start-Ig: NCT07202078, ACTRN12624000964516
- Stop-Ig: NCT07202091, ACTRN12624000963527
- Dose-Ig: NCT07202065, ACTRN12624000962538
If eligible to participate in a domain of the RATIONAL-PT, you ractive 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 researchers are still interested in your outcomes.
At the end of your participation in 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 whcih treatment to prescribe to try to prevent serious infections.
Conditions
This trial is treating people with any haematological malignancy, including chronic lymphocytic leukaemia, multiple myeloma or non-Hodgkin's lymphoma