Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001201167
Ethics application status
Approved
Date submitted
8/08/2019
Date registered
27/08/2019
Date last updated
3/03/2023
Date data sharing statement initially provided
27/08/2019
Date results information initially provided
5/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immunoglobulin use and outcomes in Chronic lymphocytic leukaemia And Non-Hodgkin lymphoma - The ICAN Study
Scientific title
Immunoglobulin use and outcomes in Chronic lymphocytic leukaemia And Non-Hodgkin lymphoma - The ICAN Study
Secondary ID [1] 298956 0
None
Universal Trial Number (UTN)
Trial acronym
ICAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukaemia 313944 0
Non-Hodgkin's Lymphoma 313945 0
Condition category
Condition code
Cancer 312349 312349 0 0
Leukaemia - Chronic leukaemia
Cancer 312350 312350 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 312351 312351 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Patients who are diagnosed with chronic lymphocytic leukaemia (CLL) or non-Hodgkin lymphoma (NHL), and participate in the Lymphoma and Related Disease Registry (LaRDR) will have their immunoglobulin and antibiotic use, and infection data entered into the study-specific database. These patients have a greater risk of infections because their level of protective antibodies is affected by their disease and treatment. Immunoglobulin (Ig) therapy is commonly used to prevent or treat infections in these patients by replacing their missing antibodies.

This study will utilise the same opt-out consent model as the LaRDR, where eligible patients are informed about the nature of the registry through a patient information brochure. Participants are then able to opt-out of the registry before, or any time after, joining the registry by informing their treating clinicians or contacting registry staff.

The ICAN study will collect ‘real world’ up-to-date Australian clinical and laboratory information on immunoglobulin and antibiotic use in these patients to guide policy and clinical practice; plan and deliver care; and monitor practice, costs, and outcomes. Data will be collected at the following time points: diagnosis (baseline) 6-months, 12-months, 18-months and 24-months.

The biobank sub-study will collect blood samples from 50 CLL and NHL patients at Victorian sites for routine and advanced immune profiling. Biobank participants will be provided with a patient informed consent form, which will be signed and dated by the participant before sample collection.

Biobank participants will be asked to provide 30mL of non-fasting blood (serum and EDTA whole blood) from the antecubital vein at baseline (before treatment), 6-months, 12-months and 24-months. Blood will be collected into specific tubes (EDTA tube and Serum separator tube) for processing and isolation of plasma, serum, peripheral blood mononuclear cell (PBMC) and circulating cell-free nucleic acids.
Intervention code [1] 315232 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320979 0
Composite primary outcome: Number and type of infection episodes (viral, bacterial, fungal, not categorised).
Data will be collected via study-specific case report forms.
Timepoint [1] 320979 0
Baseline, 6, 12, 18, and 24-months.
Primary outcome [2] 320980 0
The number of microbiologically documented infections.
Data will be collected via study-specific case report forms.
Timepoint [2] 320980 0
Baseline, 6, 12, 18, and 24-months
Primary outcome [3] 320981 0
Composite primary outcome: Number of CTCAE Grade 3 and number of CTCAE Grade 4 or greater infections
Timepoint [3] 320981 0
Baseline, 6, 12, 18, and 24-months
Secondary outcome [1] 373596 0
Overall Survival
Timepoint [1] 373596 0
Baseline, 6, 12, 18, and 24-months
Secondary outcome [2] 373597 0
Number of Hospitalisations due to infection.
Data will be collected via study-specific case report forms.
Timepoint [2] 373597 0
Baseline, 6, 12, 18, and 24-months
Secondary outcome [3] 373598 0
Infection-related mortality (defined as death within 7 days of diagnosis of infection, confirmed by microbiological means)
Timepoint [3] 373598 0
Baseline, 6, 12, 18, and 24-months
Secondary outcome [4] 373599 0
Disease progression measured.
Data will be collected via study-specific case report forms.
Timepoint [4] 373599 0
Baseline, 6, 12, 18, and 24-months
Secondary outcome [5] 373601 0
Composite secondary outcome: Number and length of interruptions to therapy due to infections.
Data will be collected via study-specific case report forms.
Timepoint [5] 373601 0
Baseline, 6, 12, 18, and 24-months

Eligibility
Key inclusion criteria
Newly diagnosed with CLL or B-cell NHL
A participant in the LaRDR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who decline to participate
For Biobank participants: Patients who have commenced treatment

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/07/2019
Date of last participant enrolment
Anticipated
Actual
31/07/2021
Date of last data collection
Anticipated
31/07/2022
Actual
31/07/2022
Sample size
Target
500
Accrual to date
Final
576
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14470 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 14482 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 14483 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 14488 0
Epworth Richmond - Richmond
Recruitment hospital [5] 14490 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 14491 0
The Canberra Hospital - Garran
Recruitment hospital [7] 14492 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 14498 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [9] 14499 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 14500 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 27485 0
3168 - Clayton
Recruitment postcode(s) [2] 27495 0
3084 - Heidelberg
Recruitment postcode(s) [3] 27500 0
3121 - Richmond
Recruitment postcode(s) [4] 27502 0
6009 - Nedlands
Recruitment postcode(s) [5] 27503 0
2605 - Garran
Recruitment postcode(s) [6] 27504 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 27510 0
4350 - Toowoomba
Recruitment postcode(s) [8] 27511 0
5000 - Adelaide
Recruitment postcode(s) [9] 27512 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 303503 0
Government body
Name [1] 303503 0
National Blood Authority
Country [1] 303503 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 303682 0
None
Name [1] 303682 0
Address [1] 303682 0
Country [1] 303682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304026 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304026 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
Clayton, Victoria 3168
Ethics committee country [1] 304026 0
Australia
Date submitted for ethics approval [1] 304026 0
Approval date [1] 304026 0
08/03/2019
Ethics approval number [1] 304026 0

Summary
Brief summary
The purpose of this study is to evaluate the outcomes of immunoglobulin (Ig) therapy in people who have non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukaemia (CLL). In Australia, Ig therapy is commonly used to prevent infection in patients with CLL and NHL, but there is limited evidence from clinical studies to guide doctors on which patients are most likely to benefit, when treatment should start, and for how long it should continue.

Whos it for?

Individuals 18 years or older with newly diagnosed B-cell Non-Hodgkin lymphoma or Chronic Lymphocytic Leukaemia.

Study Details

Participants will attend their medical appointments at the discretion of their treating clinician. Data will be collected for the ICAN database at six-monthly intervals (6, 12,18 and 24 months) starting from the date of diagnosis. Additional assessments involve questionnaires about the participants quality of life.

Participants of the biobank sub-study will be asked to provide non-fasting blood samples (30mL) at baseline (before treatment), 6-months, 12-months and 24-months. Once collected the blood samples will be stored for future testing and analysis.

Results from this study will be valuable in assisting research that improves the prevention, diagnosis and treatment of infections in people with these illnesses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95586 0
A/Prof Zoe McQuilten
Address 95586 0
Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne VIC 3004
Country 95586 0
Australia
Phone 95586 0
+61 3 990 30379
Fax 95586 0
Email 95586 0
[email protected]
Contact person for public queries
Name 95587 0
A/Prof Zoe McQuilten
Address 95587 0
Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne VIC 3004
Country 95587 0
Australia
Phone 95587 0
+61 3 9903 0379
Fax 95587 0
Email 95587 0
[email protected]
Contact person for scientific queries
Name 95588 0
A/Prof Zoe McQuilten
Address 95588 0
Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne VIC 3004
Country 95588 0
Australia
Phone 95588 0
+61 3 990 30379
Fax 95588 0
Email 95588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, only aggregate participant data will be published


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.