A Trial to evaluate treatments for patients with haematological disease who also have low levels of immunoglobulins (antibodies) in the blood (hypogammaglobulinemia).

Phase 2

Recruiting

• Conditions: haematological malignancy; hypogammaglobulinemia; Cancer - Myeloma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12616001723471
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients are eligible for this trial if:
1 Age greater than or equal to 18 years
2 Acquired hypogammaglobulinaemia secondary to a haematological malignancy
3 Meet the Australian National Blood Authority Criteria for the Clinical Use of intravenous immunoglobulin (IVIg) for secondary hypogammaglobulinaemia (i.e. total IgG below local lower limit of reference range [excluding paraprotein] and history of recurrent or severe bacterial infection(s) OR IgG < 4 g/L [excluding paraprotein])
4 Life expectancy > 12 months.
5 Willing and able to attend for monthly IVIg infusion or to self-administer subcutaneous immunoglobulin.
6 Able to give informed consent to participate.

Exclusion Criteria

Patients will not be eligible for this study if they fulfil any of the following criteria:
1 Patient unwilling or unable to give informed consent.
2 llogeneic haematopoietic stem cell transplantation recipient.
3 Patient has an objection to receiving immunoglobulin.
4 Known severe IgA deficiency
5 History of anaphylactic reaction to human immunoglobulin preparation
6 Patient already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection. Patients receiving dapsone or intermittently-dosed cotrimoxazole for PJP prophylaxis are not excluded from the study.
7 Patient has received immunoglobulin replacement in the preceding 3 months
8 Current active infection requiring systemic antimicrobial agents
9 Anticipated prolonged significant cytopenias, defined by neutrophils < 0.5 x10^9/L or platelets < 50 x10^9/L, precluding regular cotrimoxazole. Temporary cytopenia/s due to therapy are not an exclusion.
10 History of epilepsy
11 Pregnant or breastfeeding
12 Severe renal impairment (creatinine clearance of <30ml/min)
13 Previous splenectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified