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CompletedLast updated: 30 January 2024

RATIONAL: This phase II trial is comparing an oral antbiotic treatment with an intravenous treatment for patients with blood cancer who have low levels of antibodies in their blood (hypogammaglobulinemia)A randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies

Clinical summary

Summary

The aim of this study is to examine whether oral antibiotics can be used instead of intravenous immunoglobulin (IVIg) to reduce the risk of infections in people with blood cancers. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an acquired hypogammaglobulinaemia secondary to a haematological malignancy. Study details Participants will be randomised (allocated by chance) to one of two treatment groups in a 2:1 ratio meaning that you are twice as likely to receive intervention treatment. Participants in one group (intervention) will receive co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg orally once a day or doxycycline 100mg once daily for those hypersensitive to co-trimoxazole. Participants in the second group (control) will receive standard care treatment with intravenous or subcutaneous immunoglobulin (IVIg or SCIg) in accordance with national Criteria: Monthly (every 4 weeks +/- 1 week) dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age specific serum IgG reference range. The duration of each treatment is for 12 months from study entry, or until the treating physician determines that the patient should come off the treatment. The following data will be collected: Patient demographics (age, gender, diagnosis, stage of disease), baseline investigations (including IgG levels), grade 3 or 4 infections and other clinically significant infections – at monthly intervals for 12 months. This project aims to improve how we use IVIg in Australia by asking: Are prophylactic (preventive) oral antibiotics equivalent to immunoglobulin.

Conditions

This trial is treating patients with blood cancer who have low levels of antibodies in their blood.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

RATIONAL

More information

Trial Identifiers

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Trial sponsor

Monash University

Scientific Title

A randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies

Eligibility

Inclusion

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

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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