Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000056493p
Ethics application status
Submitted, not yet approved
Date submitted
25/11/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Microbiome and Fibre Supplementation in Chimeric Antigen Receptor T cell Therapy - phase I clinical trial of safety and feasibility of oral fibre supplementation in CAR T
Scientific title
Microbiome and Fibre Supplementation in Chimeric Antigen Receptor T cell Therapy patients - phase I clinical trial of safety and feasibility of oral fibre supplementation in CAR T
Secondary ID [1] 313454 0
None
Universal Trial Number (UTN)
Trial acronym
Micro Fibre CAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Leukaemia 335857 0
Lymphoma 335855 0
Myeloma 335856 0
Condition category
Condition code
Cancer 332431 332431 0 0
Leukaemia - Acute leukaemia
Cancer 332430 332430 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 332429 332429 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 332432 332432 0 0
Leukaemia - Chronic leukaemia
Cancer 332433 332433 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm patients receive an oral prebiotic fibre supplement in addition to standard of care CAR T and supportive care. The supplement will be taken twice per day from the day after collection of cells to manufacture CAR T until 30 days after CAR T administration (approximately 8-12 weeks supplementation period depending on CAR T manufacture time).

The prebiotic is a powdered fibre supplement mix of inulin (4g), resistant starch (8g), and psyllium (3.5g) combined into a single serve sachet. Two sachets per day will provide a combined dose of 8g inulin, 16g resistant starch and 7g psyllium (providing 31g of supplement and a total of 22g fibre including 7g from inulin, 5g from psyllium and 10g from resistant starch).

Adherence will be assessed by patient reporting as well as supplement sachet return.
Intervention code [1] 330028 0
Treatment: Drugs
Comparator / control treatment
Control arm patients receive standard of care CAR T therapy and supportive care. This includes standard commercial CAR T products available in Australia and supportive therapies required for CAR T administration including intravenous fluids, intravenous antibiotics and therapies to manage immune related toxicities as appropriate (including corticosteroids and other immune-modifying therapies).
Control group
Active

Outcomes
Primary outcome [1] 339979 0
To determine the feasibility of a dietary Prebiotic Fibre supplement (PFS) in CAR T therapy
Timepoint [1] 339979 0
At day 0 at CAR T infusion, 7 days after CAR T infusion and 30 days after CAR T infusion when the supplement period ends.
Primary outcome [2] 339980 0
To determine the composite outcome of safety and tolerability of a dietary PFS in CAR T therapy.
Timepoint [2] 339980 0
At day 0 at CAR T infusion, 7 days after CAR T infusion and 30 days after CAR T infusion when the supplement period ends.
Secondary outcome [1] 442152 0
To determine the incidence and severity of immune-related adverse events with CAR T after oral dietary PFS. This will be assessed as a composite outcome.
Timepoint [1] 442152 0
Assessed within first 6 months after CAR T treatment.
Secondary outcome [2] 443727 0
Length of hospital stay
Timepoint [2] 443727 0
Within 6 months of CAR T administration
Secondary outcome [3] 442151 0
To determine the clinical response to CAR T therapy with oral dietary PFS.
Timepoint [3] 442151 0
30 days and 6 months after CAR T infusion
Secondary outcome [4] 442175 0
Assess quality of life with prefibrotic fibre supplement
Timepoint [4] 442175 0
1 week and 1 month after CAR T infusion
Secondary outcome [5] 442153 0
To determine the adequacy of dietary intake, nutritional status and incidence and severity of gastrointestinal symptoms. This will be assessed as a composite outcome
Timepoint [5] 442153 0
Within first 6 months after CAR T infusion
Secondary outcome [6] 443726 0
Overall survival after CAR T administration
Timepoint [6] 443726 0
6 months following end of treatment
Secondary outcome [7] 443728 0
Incidence of infection
Timepoint [7] 443728 0
Within 6 months of CAR T adminsitration

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years old
Planned recipient of CAR T cell therapy as part of standard of care indication (DLBCL, MCL, B-ALL and Myeloma)
Ability to provide voluntary informed consent.
Willing and able to commence daily oral intake of PFS for potentially up to 90 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflammatory bowel disease
Formal diagnosis of irritable bowel syndrome
Gastrointestinal resection, ileostomy or colostomy
Any bariatric surgery including gastric bypass surgery, sleeve gastrectomy and gastric band
Any other contraindication to a high fibre diet (e.g. active diverticulitis or bowel obstruction)
Allergy/intolerance to any ingredient in the PFS
Current and planned ongoing consumption of other probiotic or prebiotic supplements.
Hepatitis B, hepatitis C or HIV infection unless viral load negative
On carbamazepine
Enrolled in CAR T cell clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA

Funding & Sponsors
Funding source category [1] 317892 0
Commercial sector/Industry
Name [1] 317892 0
Gilead Australia Fellowship Grants program
Country [1] 317892 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 320318 0
None
Name [1] 320318 0
Address [1] 320318 0
Country [1] 320318 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316578 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 316578 0
Ethics committee country [1] 316578 0
Australia
Date submitted for ethics approval [1] 316578 0
02/10/2024
Approval date [1] 316578 0
Ethics approval number [1] 316578 0

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

Contacts
Principal investigator
Name 138306 0
A/Prof Andrea Henden
Address 138306 0
Department of Cancer Care Services, Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 138306 0
Australia
Phone 138306 0
+61736461340
Fax 138306 0
Email 138306 0
[email protected]
Contact person for public queries
Name 138307 0
Andrea Henden
Address 138307 0
Department of Cancer Care Services, Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 138307 0
Australia
Phone 138307 0
+61736461340
Fax 138307 0
Email 138307 0
[email protected]
Contact person for scientific queries
Name 138308 0
Andrea Henden
Address 138308 0
Department of Cancer Care Services, Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 138308 0
Australia
Phone 138308 0
+61736461340
Fax 138308 0
Email 138308 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 who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by the listed Principal Investigator (email: [email protected])

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


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.