Trial registered on ANZCTR


Trial ID
ACTRN12605000213640
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
25/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infusion of donor-derived CMV peptide-specific CTL after allogeneic HSCT
Scientific title
A Phase I clinical trial of infusion of donor-derived HLA-A*0201-restricted CMV pp65 peptide-specific CTL to reconstitute CMV-specific immunity after allogeneic haematopoietic stem cell transplantation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune reconstitution post-allogeneic haematopoietic stem cell transplantation 296 0
Condition category
Condition code
Other 333 333 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase I study of intravenous infusion of monocyte-derived dendritic cell-primed, donor-derived, HLA-A*0201-restricted, CMV pp65 peptide-specific in vitro expanded cytotoxic T lymphocytes on or after day 28 post stem cell infusion.
Intervention code [1] 231 0
Prevention
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 390 0
Safety of donor-derived CMV-specific CTL infusion post-transplant
Timepoint [1] 390 0
Primary outcome [2] 391 0
Feasibility of donor-derived CMV-specific CTL infusion post-transplant
Timepoint [2] 391 0
Secondary outcome [1] 859 0
Persistence/reconstitution of CMV-specific CTL.
Timepoint [1] 859 0

Eligibility
Key inclusion criteria
HLA-A*0201 pos and CMV seropositive donor, 5/6 or 6/6 sib match or 6/6/MUD, GVHD < grade II at the time of infusion, >day 28 post allogeneic HSCT, no recent anti-lymphocyte globulin.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 393 0
Charities/Societies/Foundations
Name [1] 393 0
Leukaemia Foundation Clinical Research Fellowship
Address [1] 393 0
Country [1] 393 0
Primary sponsor type
Hospital
Name
Department of Haematology, Westmead Hospital
Address
Country
Australia
Secondary sponsor category [1] 322 0
None
Name [1] 322 0
Nil
Address [1] 322 0
Country [1] 322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1382 0
Westmead Hospital
Ethics committee address [1] 1382 0
Ethics committee country [1] 1382 0
Australia
Date submitted for ethics approval [1] 1382 0
Approval date [1] 1382 0
Ethics approval number [1] 1382 0
Ethics committee name [2] 1383 0
Children's Hospital, Westmead
Ethics committee address [2] 1383 0
Ethics committee country [2] 1383 0
Australia
Date submitted for ethics approval [2] 1383 0
Approval date [2] 1383 0
Ethics approval number [2] 1383 0

Summary
Brief summary
CMV infection or reactivation causes morbidity and mortality in patients after allogeneic HSCT. We aim to adoptively transfer donor-derived CMV-specific CTL to prevent CMV infection and reactivation in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35394 0
Address 35394 0
Country 35394 0
Phone 35394 0
Fax 35394 0
Email 35394 0
Contact person for public queries
Name 9420 0
A/Prof David Gottlieb
Address 9420 0
Department of Haematology
Westmead Hospital
Westmead NSW 2145
Country 9420 0
Australia
Phone 9420 0
+61 2 98456352
Fax 9420 0
Email 9420 0
david_gottlieb@wmi.usyd.edu.au
Contact person for scientific queries
Name 348 0
Dr Ken Mickelthwaite
Address 348 0
Leukaemia Research Laboratory
Westmead Millennium Institute
Westmead NSW 2145
Country 348 0
Australia
Phone 348 0
+61 2 98456352
Fax 348 0
Email 348 0
ken_mick@wmi.usyd.edu.au