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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03806764




Registration number
NCT03806764
Ethics application status
Date submitted
7/01/2019
Date registered
16/01/2019
Date last updated
16/01/2019

Titles & IDs
Public title
Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient
Scientific title
Assessing the Impact and Complications of Cytomegalovirus (CMV) Reactivation in a Multi-site Study of Allogeneic Haematopoietic Stem Cell Transplant Recipient
Secondary ID [1] 0 0
CReSCT
Universal Trial Number (UTN)
Trial acronym
CReSCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infections 0 0
Haematological Malignancy 0 0
Organ or Tissue Transplant; Complications 0 0
Immune Suppression 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Blood sampling

No Intervention: Retrospective study - Medical records of 250 allo-HSCT recipients will be evaluated retrospectively to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes.

Other: Prospective study - 120 recipients of allo-HSCT will be recruited into the prospective part of the study. Participants will be reviewed pre-transplant, 6, 12, 24 and 52 weeks following HSCT during routine clinical visits. clinical assessment will be made such as CMV viremia, transplant related complications and current medications.
Participants who are at high risk of CMV will have study blood sampling taken to assess immune functions


Diagnosis / Prognosis: Blood sampling
Blood sampling from prospective study participants will be taken for immune functions measurements

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and outcome of CMV viremia - The incidence and outcome of clinically relevant CMV viremia post HSCT will be assessed
Timepoint [1] 0 0
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
Primary outcome [2] 0 0
Host CMV-specific T cell immunity and related clinical outcomes - Host CMV-specific T cell immunity status of 120 participants will be assessed prospectively against CMV related clinical outcomes to establish if correlations exist
Timepoint [2] 0 0
52 weeks following HSCT
Secondary outcome [1] 0 0
Low level CMV viremia - Association of low level CMV viremia and the subsequent clinical outcomes
Timepoint [1] 0 0
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
Secondary outcome [2] 0 0
Economic cost for managing CMV infection - The economic cost attributable to managing CMV infection and CMV disease will be evaluated to provide a picture of health economics of the infection
Timepoint [2] 0 0
250 retrospective cases of HSCTduring 2012 to 2017, inclusive, will be reviewed from the day of transplant to 6 months post transplant.
Secondary outcome [3] 0 0
CMV viral load for initiation of treatment - CMV viral load will be assessed to determine an appropriate trigger to initiate treatment for CMV viremia
Timepoint [3] 0 0
52 weeks following HSCT
Secondary outcome [4] 0 0
Correlation of host T cell function and risk of CMV infection - Association of low or inadequate global immune function (T-cell and TLR7 responses) will be correlated with an increased risk of developing CMV infection post HSCT
Timepoint [4] 0 0
52 weeks following HSCT

Eligibility
Key inclusion criteria
- For the retrospective cohort, all 250 consecutive allo-HSCT patients between 2012 to
2017 at the Royal Melbourne Hospital will be included, with CMV-negative patients
acting as controls for economic comparisons.

- For the prospective cohort, patients undergoing allo-HSCT, at risk of CMV disease
(D+/R+, D-/R+ D+/R-), and able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- For the retrospective cohort, no exclusion is set.

- For the prospective cohort, patients who has CMV disease at the time of enrolment and
patients who are unable to provide informed consent.

Study design
Purpose of the study
Diagnosis
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Western Sydney Local Health District
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Walter and Eliza Hall Institute of Medical Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Austin Hospital, Melbourne Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study consists of two parts: 1) Part 1, a retrospective part on 250 consecutive patients
following allogeneic haematopoietic stem cell transplant (allo-HSCT) at the Royal Melbourne
Hospital from 2012 to 2017, inclusive, and 2) Part 2, a prospective part on 120 allo-HSCT
patients from 4 sites in Australia: the Royal Melbourne Hospital, Peter MacCallum Cancer
Centre, Austin Hospital, and Westmead Hospital.

In Part 1, medical records of allo-HSCT recipients will be evaluated to determine the
incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV
disease) and indirect (such as invasive fungal infection, other viral infections, bacterial
infection) effects on clinical outcomes.

In Part 2, allo-HSCT participants at risk of CMV disease will be assessed to determine the
association of host CMV-specific immunity with clinical management and outcomes over one year
post allo-HSCT.

The overall aims of the study are to establish if CMV infection in allo-HSCT patients are
associated with poor clinical outcomes; and whether measurement of immunological functions
could provide an early indicator to identify patients at risk and appropriate timing for
initiation of CMV treatment.
Trial website
https://clinicaltrials.gov/show/NCT03806764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Monica Slavin, MBBS FRACP
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03806764