Summary
This research project forms part of the RATIONAL Platform Trial. 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 people with blood cancers.
While immunoglobulin is commonly used long-term in people with blood cancer, we don't know whether oral antibiotics are just as good at preventing serious infections. The research project is investigating the use of oral antibiotics (in tablet form) to determine if they are as effective as immunoglobulin (either IVIg or SCIg) in reducing the risk of infections in people with blood cancers.
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 to find out if you're eligible to participate, and you will need to undergo screening assessments to see if it's safe for you to be involved.
Study details
In this clinical trial domain, participants will be divided into two groups (arms) to compare the different treatments. There is one usual care group and one investigational group. Each participant is put into a group by chance (randomly). The two groups are:
- Start immunoglobulin (IVIg or SCIg) replacement therapy.
- Start oral antibiotics to take every day.
If you are 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 phon ecall 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 with blood cancers. Your participation may help doctors who treat people with blood diseases in future to know whether to prescribe oral antibiotics or immunoglobulins to try to prevent the onset of serious infections.
Conditions
This trial is treating people with a haematological malignancy, including chronic lymphocytic leukaemia (CLL), multiple myeloma (MM), or non-Hodgkin's lymphoma (NHL) and are eligible to receive immunoglobulin replacement