None listed
Conditions
Brief summary
This research project forms part of the RATIONAL Platform Trial. This study is being conducted to find out if a lower dose of immunoglobin is as effective in preventing infections in patients with blood cancers receiving immunoglobulin who have trialled stopping in the past without success or are not suitable to trial stopping immunoglobulin. This research will investigate if patients can safely reduce their immunoglobulin dose after six months of therapy. Who’s 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: In this clinical trial, participants will be divided into two groups (arms) to compare the different treatments. There is one usual care group and one investigational group. The two groups are: 1. Continue standard-dose immunoglobulin (IVIg) replacement therapy 2. Commence low-dose immunoglobulin (IVIg) replacement therapy Each participant is put into a group by chance (randomly). Half of the participants will receive standard-dose immunoglobulin, the other half will commence low-dose immunoglobulin replacement 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 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 (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 patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know what dose of immunoglobulins should be prescribed to try to prevent the onset of serious infections.
Interventions
Arm A: Low dose intravenous immunoglobulin replacement
- Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum IgG levels is required.
- If a participant experiences a serious infectious complication, they may recommence standard dose immunoglobulin replacement therapy (IgRT), as directed by their treating clinician. In the absence of a serious infectious complication, the treating clinician may i
Arm A: Low dose intravenous immunoglobulin replacement - Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum IgG levels is required. - If a participant experiences a serious infectious complication, they may recommence standard dose immunoglobulin replacement therapy (IgRT), as directed by their treating clinician. In the absence of a serious infectious complication, the treating clinician may increase the dose of IgRT if this is deemed in the participant’s best interest. - Adherence to the intervention will be assessed via review of participant medical records. Duration of Intervention: 12 months.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible for the Dose-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Dose-Ig domain. RATIONAL-PT inclusion criteria: 1. Aged greater than or equal to 18 years of age 2. Diagnosis of haematological malignancy, including Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (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 Dose-Ig domain inclusion criteria: 1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months. 2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
Exclusion criteria
Patients are eligible for the Dose-Ig domain of the RATIONAL-PT if they fulfil eligibility for both RATIONAL-PT and the Dose-Ig domain. RATIONAL-PT exclusion criteria: 1. Treating team deems enrolment in the study is not in the best interests of the patient Dose-Ig domain exclusion criteria: 1. Prior or planned allogeneic haematopoietic stem cell transplantation. 2. Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment. 3. Previous splenectomy. 4. Known history of bronchiectasis. 5. Previous participation in this domain. 6. Treating team deems enrolment in the domain is not in the best interest of the patient.
Outcome results
None listed