Summary
This research forms part of the RATIONAL Platform Trial. This study aims to find out whether people with blood cancers who are receiving immunoglobulin therapy (IVIg or SCIg) to prevent infections can safely stop after six months and instead take oral antibiotics to prevent serious infections. It will also test whether oral antibiotics should be taken daily or only when symptoms of an infection appear.
You may be eligible if you have a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check if you are eligible to participate, and you'll need to complete screening assessments to ensure it's safe for you to participate.
Study details
In this clinical trial domain, participants will be divided into three groups (arms) to compare the different treatments. There is one usual care group and two investigational groups. Each participant is put into a group by chance (randomly). The three groups are:
- Continue immunoglobulin - this is the usual care group
- Stop immunoglobulin and take daily oral antibiotics
- Stop immunoglobulin and keep oral antibiotics at home to take only when infection symptoms start
If eligible to participate in a domain of RATIONAL-PT, your active 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 people wtih blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know whether to prescribe oral antibiotics or immunoglobulins to try to prevent the onset of serious infections.