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Clinical Trial Details

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

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Trial Information

Broad Health Condition Cancer
Cancer
Cancer

Specific Health ConditionMyeloma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Leukaemia - Chronic leukaemia

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,TAS,WA,VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton
Concord Private Hospital - Concord
Fiona Stanley Hospital - Murdoch
The Canberra Hospital - Garran
Royal Hobart Hospital - Hobart


Postcode
3168 - Clayton
2137 - Concord
6150 - Murdoch
2605 - Garran
7000 - Hobart


Trial location outside Australia
New ZealandWellington, Capital & Coast District
New ZealandWaikato

Anticipated date of first participant enrolment1/02/2017

Anticipated date of last participant enrolment1/02/2017

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial 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 
Eligibility

Key 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.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: Monash University
Primary Sponsor Address: Wellington Road, Clayton VIC 3800
Primary Sponsor Country: Australia

Trial IDACTRN12616001723471

Contact person for information and recruitmentDr
Zoe McQuilten
Monash University Department of Epidemiology and Preventive Medicine The Alfred Centre 99 Commercial Road Melbourne, VIC 3004
+61 3 99030379

Further information iconzoe.mcquilten@monash.edu
Australia