Summary
This research project forms part of the RATIONAL Platform Trial. The study is being conducted to find out whether a lower dose of immunoglobulin (IVIg) is just as effective as preventing infections in people with blood cancers who have tried stopping in the past without success, or are not suitable to trial stopping immunoglobulin. The research will investigate if people can safely reduce their immunoglobulin dose after six months of therapy.
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 see if you are eligible to join, 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 two gropus (arms) to compare the different treatments. There is one usual care group and one investigational group. Each participant will be put into a group by chance (randomly). The two groups are:
- Continue standard-dose immunoglobulin replacement therapy
- Start low-dose immunoglobulin therapy
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 researchers 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 (standard-dose or low-dose immunoglobulin).
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 what dose of immunoglobulin should be prescribed to try to prevent the onset of serious infections.
Conditions
This trial is treating people with blood cancers including chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) who are receiving IVIg replacement at a standard dose for infection prevention