Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000129482
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
4/02/2016
Date last updated
13/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adoptive Immunotherapy for Liver Cancer
Scientific title
Survival after T cell receptor-redirected autologous T cell therapy against relapsed hepatitis B virus-induced hepatocellular carcinoma in a liver transplanted patient.
Secondary ID [1] 288237 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 297164 0
Hepatitis B virus 297165 0
Liver Transplant 297246 0
Condition category
Condition code
Cancer 297383 297383 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 infusions at 7 day intervals of increasing doses of 10,000 (1 infusion), 100,000 (1 infusion), 1,000,000 (1 infusion) and 5,000,000 (5 infusions) cells /kg of autologous t cell receptor-redirected T cells that recognise a hepatitis B virus envelope peptide (FLGPLLVLQA) presented by HLA-Cw*0801. The cells will be prepared in the New Zealand Liver Transplant Research laboratory at Auckland City Hospital and administered by IV infusion by nursing staff.
Intervention code [1] 293525 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296934 0
Survival
Timepoint [1] 296934 0
1 year
Secondary outcome [1] 319726 0
Tumor mass will be assessed after the 4th and 8th infusions by MRI and PET scan.
Timepoint [1] 319726 0
Assessed after the 4th and 8th infusions.

Eligibility
Key inclusion criteria
Relapsed post-transplant hepatocellular carcinoma
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant psychiatric disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis
Nil

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2016
Date of last participant enrolment
Anticipated
Actual
5/01/2016
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
1
Accrual to date
Final
1
Recruitment outside Australia
Country [1] 7496 0
New Zealand
State/province [1] 7496 0

Funding & Sponsors
Funding source category [1] 292620 0
University
Name [1] 292620 0
Duke-Nus Medical School
Country [1] 292620 0
Singapore
Primary sponsor type
University
Name
Duke-Nus Medical School
Address
Duke-NUS Graduate Medical School
8 College Road, Singapore 169857
Country
Singapore
Secondary sponsor category [1] 291338 0
Hospital
Name [1] 291338 0
Auckland City Hospital
Address [1] 291338 0
Private Bag 92-024, Auckland, 1142.
Country [1] 291338 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294098 0
Central Health and Disability Ethics Committee.
Ethics committee address [1] 294098 0
Ethics committee country [1] 294098 0
New Zealand
Date submitted for ethics approval [1] 294098 0
01/12/2015
Approval date [1] 294098 0
18/12/2015
Ethics approval number [1] 294098 0
15/CEN/217

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

Contacts
Principal investigator
Name 62470 0
Dr William Abbott
Address 62470 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62470 0
New Zealand
Phone 62470 0
+64275483711
Fax 62470 0
Email 62470 0
[email protected]
Contact person for public queries
Name 62471 0
William Abbott
Address 62471 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62471 0
New Zealand
Phone 62471 0
+64275483711
Fax 62471 0
Email 62471 0
[email protected]
Contact person for scientific queries
Name 62472 0
William Abbott
Address 62472 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62472 0
New Zealand
Phone 62472 0
+64275483711
Fax 62472 0
Email 62472 0
[email protected]

No information has been provided regarding IPD availability


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.