Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001089426p
Ethics application status
Not yet submitted
Date submitted
17/09/2025
Date registered
7/10/2025
Date last updated
7/10/2025
Date data sharing statement initially provided
7/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ALLG LS27: A genomic study of lymphoma in patients with suspected inborn errors of immunity.
Scientific title
ALLG LS27: A genomic study of lymphoma in patients with suspected inborn errors of immunity.
Secondary ID [1] 315398 0
ALLG LS27
Universal Trial Number (UTN)
Trial acronym
LYMPH-IEI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 338903 0
Condition category
Condition code
Cancer 335199 335199 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective observational study will enroll individuals with lymphoma and suspected inborn errors of immunity (IEI). A blood and saliva sample will be collected at a visit after they have been enrolled from in an initial cohort of 20 patients. Whole exome sequencing will be used to assess these samples. Phase 1 of analysis will involve focused analysis of 99 genes recurrently implicated in immunodeficiency which draws upon national and international recommendations such as IEI Committee guidelines and Panel App. Phase 2 of analysis will involve analysis of all genes in exome sequencing to discover novel genes potentially implicated in IEI and lymphoma.

Simultaneously clinicopathologic data, testing for chronic viral infections (such as EBV), treatment toxicity data, outcome data including response and survival. Diagnostic tissue samples and peripheral blood will be collected for further testing which includes Next-Generation Sequencing profiling of tumor and immune cell repertoire, assessment of the tumor microenvironment as part of additional correlative studies.

There will be no mandated assessments beyond those required for standard diagnosis, treatment, and follow-up of lymphoma patients at the participating centres. All clinical data and samples will be collected according to routine care with focus on treatment toxicity. The schedule of assessments will therefore vary depending on the specific lymphoma subtype and treatment.
Intervention code [1] 332007 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342810 0
Inborn Error of Immunity (IEI) detection in lymphoma patients with clinical suspicion of immunodeficiency.
Timepoint [1] 342810 0
Initial visit after screening.
Secondary outcome [1] 452207 0
Clinical features of patients with confirmed IEI which includes presence of chronic viral infections, fever, inflammation, swelling, pain and fatigue.
Timepoint [1] 452207 0
Upon diagnosis of confirmed IEI.
Secondary outcome [2] 452208 0
Identification of novel genes of patients with confirmed IEI.
Timepoint [2] 452208 0
Initial visit after screening and upon diagnosis of confirmed IEI by treating physician.
Secondary outcome [3] 452210 0
Identify a list of genes either upregulated or down-regulated in lymphoma patients that develop IEI.
Timepoint [3] 452210 0
Initial visit after screening and upon diagnosis of confirmed IEI by treating physician.
Secondary outcome [4] 452521 0
Treatment-related toxicities in patients confirmed IEI.
Timepoint [4] 452521 0
Upon diagnosis of confirmed IEI by treating physician.
Secondary outcome [5] 452522 0
Event-Free Survival (EFS)
Timepoint [5] 452522 0
Initial visit after screening to failure to achieve complete remission (CR)
Secondary outcome [6] 452523 0
Overall survival (OS)
Timepoint [6] 452523 0
Initial visit after screening to the date of death from any cause.

Eligibility
Key inclusion criteria
1. Patients must be currently 18 years of age or older.
2. Confirmed diagnosis of non-Hodgkin lymphoma (NHL)
3. A high clinical suspicion for inborn errors of immunity with atleast one of the following criteria:
a) Lymphoma diagnosis before 40 years of age
b) OR
c) History of recurrent severe or atypical infections, autoimmune conditions, or documented history of immunodeficiency (e.g. severe combined immunodeficiency, common variable immunodeficiency, hypogammaglobulinaemia, severe lymphopenia).
d) OR
e) Family history of immunodeficiency/lymphoma
f) OR
g) Co-existing autoimmune conditions or immune complications (e.g. cytopenia, vasculitis, hepatitis, arthropathy, lymphoproliferation)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of post-transplant lymphoproliferative disorders (PTLD) and Hodgkin lymphoma.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2026
Actual
Date of last participant enrolment
Anticipated
11/09/2028
Actual
Date of last data collection
Anticipated
11/09/2028
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 319988 0
Other Collaborative groups
Name [1] 319988 0
Australasian Leukaemia and Lymphoma Group
Country [1] 319988 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 322519 0
None
Name [1] 322519 0
Address [1] 322519 0
Country [1] 322519 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318526 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318526 0
Ethics committee country [1] 318526 0
Australia
Date submitted for ethics approval [1] 318526 0
17/12/2025
Approval date [1] 318526 0
Ethics approval number [1] 318526 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144470 0
Dr Paul Yeh
Address 144470 0
Monash Medical Centre, Monash University Clayton, Victoria 3168, Australia
Country 144470 0
Australia
Phone 144470 0
+61 03 95944365
Fax 144470 0
Email 144470 0
[email protected]
Contact person for public queries
Name 144471 0
Delaine Smith
Address 144471 0
ALLG 35 Elizabeth St Richmond Vic 3121
Country 144471 0
Australia
Phone 144471 0
+61 03 83739701
Fax 144471 0
Email 144471 0
[email protected]
Contact person for scientific queries
Name 144472 0
Delaine Smith
Address 144472 0
ALLG 35 Elizabeth St Richmond Vic 3121
Country 144472 0
Australia
Phone 144472 0
+61 03 83739701
Fax 144472 0
Email 144472 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
3 months after publication

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data sharing request system: Health Data Australia. https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]


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.