An Australian multicentre trial to compare the safety and efficacy of intravenous immunoglobulin replacement therapy with subcutaneous immunoglobulin replacement therapy (Hizentra®) to treat immunoglobulin deficiency in patients with chronic lymphocytic leukaemia (CLL)

Exclusion Criteria14

• Patients with CLL who are not hypogammaglobulinaemic and hence ineligible for immunoglobulin replacement under Australian National Blood Authority Guidelines.
• Transformation of CLL to aggressive NHL (Richter’s transformation)
• Ongoing requirement for treatment with high dose corticosteroids at a dose equivalent to or greater than 30 mg/day prednisolone
• 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
• 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)
• 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
• Previous severe adverse reaction to IVIg requiring inpatient monitoring
• 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)
• 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
• 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.