None listed
Conditions
Brief summary
This study aims to assess whether subcutaneous immunoglobulin (SCIg) replacement therapy is an acceptable alternative to intravenously immunoglobulin (IVIg) replacement therapy in terms of safety and efficacy in chronic lymphocytic leukaemia (CLL) patients with acquired hypogammaglobulinaemia. Who is it for? You may be eligible to join this study if you are aged 18 years, have a diagnosis of chronic lymphocytic leukaemia (CLL) and are currently receiving IVIg. Study details Study participants will be allocated by chance to one of the three groups. One group will continue receiving IVIg monthly for at least 12 months (their usual care). Second group will receive SCIg (Hizentra®) weekly for at least 12 months and third group will receive SCIg (Hizentra®) fortnightly for at least 12 months. Safety and efficacy measures including evaluations of blood samples and completion of questionnaires will be collected over a 12 month period. This study will address whether SCIg is an acceptable alternative to IVIg in terms of safety and efficacy in patients with acquired hypogammaglobulinaemia in the setting of CLL.
Interventions
Intervention 1 - 12 months
0.2g per ml (20%) sub cutaneous immunoglobulin (SCIg) weekly, switching from intravenous immunoglobulin (IVIg), subject’s current monthly IVIg dose divided by 4 (range: 0.05 – 0.15g/kg), n= 30
Intervention 2 - 12 months
0.2g per ml (20%) sub cutaneous immunoglobulin (SCIg) fortnightly, switching from intravenous immunoglobulin (IVIg), subject’s current monthly IVIg dose divided by 2 (0.1 – 0.3g/kg), n=30
Adherence/fidelity will be established with an initial 2-4 week
Intervention 1 - 12 months 0.2g per ml (20%) sub cutaneous immunoglobulin (SCIg) weekly, switching from intravenous immunoglobulin (IVIg), subject’s current monthly IVIg dose divided by 4 (range: 0.05 – 0.15g/kg), n= 30 Intervention 2 - 12 months 0.2g per ml (20%) sub cutaneous immunoglobulin (SCIg) fortnightly, switching from intravenous immunoglobulin (IVIg), subject’s current monthly IVIg dose divided by 2 (0.1 – 0.3g/kg), n=30 Adherence/fidelity will be established with an initial 2-4 week in hospital training period where patients are educated on self administration of sub cutaneous immunoglobulin. From then on there will be a scheduled review by an investigator at 3, 6, 9 and 12 months where adherence and complications will be discussed, blood tests will also be taken to assess immunoglobulin levels. Doctors and nursing staff will be available by appointment at any time in between scheduled reviews.
Sponsors
Professor Stephen Mulligan
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
1. Diagnosis of chronic lymphocytic leukaemia (CLL) according to NCI/IWCLL criteria 2. IgG < 6.5 g/L prior to commencement of IVIg 3. Recurrent episodes of non-neutropenic bacterial infection (>2 infections per year requiring antibiotics, or severe non-neutropenic bacterial infection (requiring hospitalisation and IV antibiotics 4. Currently receiving, and stable on IVIg as per the National Blood Authority, State Australian Red Cross Blood Transfusion Service, and local institutional approved guidelines for the provision of IVIg, or patients requiring commencement of immunoglobulin replacement therapy according to standard guidelines 5. An ECOG performance status score of 0-2 at Screening 6. Able to comply with study protocol procedures and a minimum of 1 month of follow-up 7. Able to provide written informed consent 8. Adequate level of physical and mental capacity to allow self-administration of SCIg following a training period 9. Ability to adhere to a self-administration treatment plan 10. Life expectancy of at least 12 months
Exclusion criteria
1. Patients with CLL who are not hypogammaglobulinaemic and hence ineligible for immunoglobulin replacement under Australian National Blood Authority Guidelines. 2. Transformation of CLL to aggressive NHL (Richter’s transformation) 3. Ongoing requirement for treatment with high dose corticosteroids at a dose equivalent to or greater than 30 mg/day prednisolone 4. Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying leukaemia): a. AST or ALT greater than or equal to 2.5 × ULN b. Total bilirubin greater than or equal to 3 × ULN 5. One or more individual organ / system impairment score(s) of 4 as assessed by the CIRS definition (i.e. extremely severe problem and/or immediate treatment required and/or organ failure and/or severe functional impairment) 6. Prior diagnosis of malignancy, unless: a. the malignancy has been treated with a curative intent and there is no evidence of recurrence or b. in remission without treatment for greater than or equal to 2 years prior to study enrolment 7. Previous severe adverse reaction to IVIg requiring inpatient monitoring 8. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) 9. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalisation (relating to the completion of the course of antibiotics, except if for tumour fever) within 4 weeks prior to the start of Cycle 1 10. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Outcome results
None listed