Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000859583p
Ethics application status
Not yet submitted
Date submitted
19/06/2024
Date registered
12/07/2024
Date last updated
12/07/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing Dynamic Immune Biomarkers in Follicular Lymphoma Patients Treated with Bispecific Antibody Therapy
Scientific title
ALLG LS25: Establishing Dynamic Immune Biomarkers in Follicular Lymphoma Patients Treated with Bispecific Antibody Therapy
Secondary ID [1] 312284 0
None
Universal Trial Number (UTN)
Trial acronym
ALLG LS25
Linked study record
This ANZCTR is a sub-study of the study registered under NCT06191744.

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 334007 0
Condition category
Condition code
Cancer 330681 330681 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Follicular lymphoma (FL) is a common type of slow-growing blood cancer. In Australia, the standard treatment for FL is a combination of drugs and immunotherapy. However, this treatment can have side effects, and the cancer can come back without clear options for further treatment.

The LS25 trial is a translational sub-study to the upcoming EPCORE-FL2 trial sponsored by AbbVie. Patients enrolled to the EPCORE-FL2 trial will be recruited to the LS25 trial and will be consented for 1) the collection of an additional volume of peripheral blood at 5 timepoints 2) self-administration of gastrointestinal microbiota sampling and 3) an ‘on-treatment’ biopsy.
All collection timepoints for the ALLG LS25 trial correspond to those in the EPCORE FL-2 clinical trial at:
1. baseline
2. cycle 1 day 15
3. on-treatment biopsy window between cycle 1 day 23 – cycle 2 day 8
4. 24 weeks
5. 120 weeks.

There are no additional collection timepoints outside of the clinical trial protocol.
Intervention code [1] 328749 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338439 0
To assess whether baseline and dynamic measures of poor immune fitness are predictive of early progression of disease (ePOD) events in Follicular Lymphoma (FL) patients (As a composite primary outcome).
Timepoint [1] 338439 0
PB at baseline, cycle 1 day 15, between cycle 1 day 23 – cycle 2 day 8, 24 weeks and 120 weeks post baseline.
Optional tissue biopsy at baseline and within the "on-treatment" biopsy collection window (between cycle 1 day 23 – cycle 2 day 8).
Microbiome swab at baseline, 24 weeks and 120 weeks post baseline.
Secondary outcome [1] 435953 0
Nil
Timepoint [1] 435953 0
Nil

Eligibility
Key inclusion criteria
Patients at who are participating in the Abbvie sponsored clinical trial titled ‘A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab and Rituximab and Lenalidomide (R2) compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE FL-2)’ are eligible to partake in the ALLG LS25 study.
1. Diagnosis of follicular lymphoma (FL).
2. Have CD20, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
3. Must have stage, III or IV disease, or stage II with bulky disease (tumor diameter of greater than or equal to 7 cm).
4. Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
5. Has one or more target lesions:
a) A positron emission tomography (PET) or computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
b) Have greater than or equal to 1 measurable nodal lesion (long axis greater than 1.5cm) or greater than or equal to 1 measurable extra-nodal lesion (long axis greater than 1.0 cm) on CT scan or MRI
6) Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
7) Eligible to receive one of the standard of care regimens: chemoimmunotherapy (CIT) or rituximab and lenalidomide (R2).
8) Have laboratory values meeting the criteria in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Had major surgery within 4 weeks prior to randomization.
2) Have active cytomegalovirus (CMV) disease..

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26363 0
New Zealand
State/province [1] 26363 0

Funding & Sponsors
Funding source category [1] 316672 0
Other Collaborative groups
Name [1] 316672 0
Australasian Leukaemia and Lymphoma Group (ALLG)
Country [1] 316672 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group (ALLG)
Address
Country
Australia
Secondary sponsor category [1] 318864 0
None
Name [1] 318864 0
Nil
Address [1] 318864 0
Country [1] 318864 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315450 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315450 0
Ethics committee country [1] 315450 0
Australia
Date submitted for ethics approval [1] 315450 0
15/07/2024
Approval date [1] 315450 0
Ethics approval number [1] 315450 0

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

Contacts
Principal investigator
Name 134742 0
Dr Joshua Tobin
Address 134742 0
Translational Research Institute, 37 Kent Street, Woolloongabba, Qld 4102
Country 134742 0
Australia
Phone 134742 0
+61 7 3365 1234
Fax 134742 0
Email 134742 0
[email protected]
Contact person for public queries
Name 134743 0
Delaine Smith
Address 134743 0
Australasian Leukaemia & Lymphoma Group, 35 Elizabeth St, Richmond, VIC 3121
Country 134743 0
Australia
Phone 134743 0
+61 3 8373 9701
Fax 134743 0
Email 134743 0
[email protected]
Contact person for scientific queries
Name 134744 0
Delaine Smith
Address 134744 0
Australasian Leukaemia & Lymphoma Group, 35 Elizabeth St, Richmond, VIC 3121
Country 134744 0
Australia
Phone 134744 0
+61 3 8373 9701
Fax 134744 0
Email 134744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply that the requester must agree to before access is granted
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (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]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23903Study 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
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