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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02779439




Registration number
NCT02779439
Ethics application status
Date submitted
18/05/2016
Date registered
20/05/2016
Date last updated
21/07/2016

Titles & IDs
Public title
Partially HLA-matched Third Party Antigen Specific T-cells for Infection Post-stem Cell or Solid Organ Transplantation
Scientific title
Therapeutic Infusion of Partially HLA-matched Third Party Donor-derived Virus- and Fungus Specific T-lymphocytes in Patients With Active Viral or Fungal Infection Post-allogeneic Stem Cell or Solid Organ Transplantation
Secondary ID [1] 0 0
R3ACT
Universal Trial Number (UTN)
Trial acronym
R3ACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CMV Infection 0 0
EBV 0 0
Adenovirus 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Virus specific CTLs

Experimental: 3rd party CTL infusion - Virus specific CTLs


Other interventions: Virus specific CTLs
Virus specific CTLs will be given to patients with persistent or recurrent viral reactivation after 2 weeks of standard anti-viral therapy

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Infusion related safety - infusion related adverse events
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion criteria
- Recipients of myeloablative or non-myeloablative allogeneic or solid organ
transplantation for any indication.

- Presence of viral reactivation or infection with CMV, Adv or EBV or invasive fungal
disease must be present at the time of infusion as determined by:

- For CMV CMV detectable by antigen detection, PCR or culture in peripheral blood
or tissue biopsy or by immunohistochemical staining on tissue biopsy specimen

- For Adv Presence of Adv as detected by PCR, antigen detection or culture in body
fluids including blood, stool, urine or nasopharyngeal secretions

- For EBV Elevated EB virus detectable in peripheral blood by PCR or Presence of
documented EBV related PTLD diagnosed by tissue biopsy or Elevated EB virus
detectable in the blood by PCR and clinical or imaging findings consistent with
EBV lymphoma

- For invasive fungal disease Proven or probable invasive fungal disease according
to De Pauw 2008[114]

- Failure of standard therapy as defined by:

- For CMV The continued presence of detectable CMV virus or antigen after at least
14 days of antiviral therapy with IV ganciclovir or foscarnet Recurrence of
detectable CMV virus or antigen after at least 2 weeks of prior antiviral therapy

- For Adv A rise or less than 50% reduction in viral load in blood or any site of
disease as measured by PCR or any quantitative assay despite use of therapy as
determined by the treating physician; Standard therapy may include intravenous
cidofovir within the limits of renal function

- For EBV Increase or less than 50% decrease in the size of EBV lymphoma or

Increase or less than 50% decrease in the EBV viral load in peripheral blood despite use of
appropriate therapy as determined by the treating physician which may include:

- Reduction in immunosuppression

- Rituximab 375mg/m2 up to 4 infusions

- Cytotoxic chemotherapy

o For invasive fungal disease inadequate or incomplete clinical response according to
treating physician after at least 5 days of best available therapy

- Adequate hepatic and renal function (< 3 x upper limit of normal for AST (SGOT), ALT
(SGPT), < 2 x upper limit of normal for total bilirubin, serum creatinine)

- ECOG status 0 to 3 or Lansky score 30-100

- Patient (or legal representative) has given informed consent
Minimum age
1 Year
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

- Grade II or greater graft versus host disease within 1 week prior to infusion.

- Prednisone or methylprednisolone at a dose of > 1 mg/kg (or equivalent in other
steroid preparations) administered within 72 hours prior to cell infusion.

- ECOG status 4 or Lansky score <30

- Privately insured in or outpatients in New South Wales participating centres (see 12.5
Indemnity issues).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and biological efficacy of therapeutically administered most closely
HLA-matched third party donor-derived specific cytotoxic T lymphocytes (CTLs) targeting
cytomegalovirus (CMV) or Adenovirus (Adv) or Epstein Barr virus (EBV) or fungi including
Aspergillus and Candida species for the treatment of viral infection following allogeneic
blood or marrow stem cell or solid organ transplantation.
Trial website
https://clinicaltrials.gov/show/NCT02779439
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Gottlieb, MD FRACP
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
david.gottlieb@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02779439