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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02895412
Registration number
NCT02895412
Ethics application status
Date submitted
23/02/2016
Date registered
9/09/2016
Date last updated
9/09/2016
Titles & IDs
Public title
Infection and Tumour Antigen Cellular Therapy
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Scientific title
A Clinical Trial of Donor-derived WT1 Specific T Cells for Prevention of Relapse in Combination With Multiple Pathogen Specific T Cells for Prevention of Infection in Patients Undergoing Allogeneic Haemopoietic Stem Cell Transplant for AML
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Secondary ID [1]
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INTACT-WT1
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Universal Trial Number (UTN)
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Trial acronym
INTACT-WT1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myelocytic, Acute
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Donor-derived WT1-CTL and P-CTL
Experimental: Transplant Recipient - The T cell product administration is personalized cellular therapy product, individually prepared for each participant.
Donor-derived WT1-CTL and P-CTL.
It's exact make up and effect is dependent on both donor and recipient characteristics and as such variability is expected in the response. These variations will be adjusted for by multiple samplings over time and collation and analysis of response in both individuals an the group as a whole.
One infusion of 2 x 107/m2 P-CTLs prophylactically on or after day 28 post-allogeneic peripheral blood haemopoietic stem cell transplant (HSCT), combined with up to four infusions of 2x107/m2 WT1-CTLs.
Other interventions: Donor-derived WT1-CTL and P-CTL
Donor-derived WT1-CTL and P-CTL.
P-CTL will be given prophylactically a minimum of 28 days after transplantation followed by administration of monthly infusions of WT1-CTL for up to four doses.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Assessment method [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Timepoint [1]
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2 Years
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Eligibility
Key inclusion criteria
1. Patients undergoing myeloablative or non-myeloablative allogeneic transplantation from
an HLA (A, B and DR) identical or 1-3 antigen mismatched family or unrelated donor
2. Transplant performed for acute myeloid leukaemia
3. Leukaemia blasts express the WT1 tumour antigen as determined by the European
LeukaemiaNet standardised assay described in 16. WT1 overexpression will be defined by
greater than 250 copies/104ABL copies in bone marrow samples or greater than 50
copies/104ABL copies in peripheral blood. This assay will be performed on samples
collected as part of routine clinical care at diagnosis and during initial treatment
prior to transplantation. Testing will be performed after consent for trial
participation has been obtained and negativity for WT1 will be classified as screening
failure
4. Recipients of peripheral blood HSCT
5. Adequate hepatic and renal function (< 3 x upper limit of normal for AST, ALT, < 2 x
upper limit of normal for total bilirubin, serum creatinine)
6. Estimated life expectancy of at least 12 months
7. Patient (or legal representative) has given informed consent
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Minimum age
1
Year
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Use of anti-lymphocyte globulin (ALG, ATG, Campath or other broad spectrum lymphocyte
antibody) given in the 4 weeks immediately prior to infusion or planned within 4 weeks
after infusion
2. Grade II or greater graft versus host disease within 1 week prior to infusion
3. Prednisone or methylprednisone at a dose of > 1 mg/kg (or equivalent in other steroid
preparations) administered within 72 hours prior to cell infusion
4. Prior allogeneic HSCT
5. Privately insured in or outpatients (see Indemnity Issues, Section 11.4)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2020
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead, Sydney
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Recruitment postcode(s) [1]
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2145 - Westmead, Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is to test a new therapy for patients with acute myeloid leukaemia who are
undergoing blood stem cell transplant. In this study, the investigators will take a small
number of your immune cells whose normal function is to give immunity to infections and help
to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will
then be given to the transplant recipient after the transplant. This is a sort of "immunity
transplant". The exact purpose of this study is to investigate if these cells are safe and
effective in patients having a transplant for AML.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02895412
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02895412
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