Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient
NCT ID: NCT03806764
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
370 participants
INTERVENTIONAL
2018-04-17
2023-12-31
Brief Summary
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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.
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Detailed Description
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This study consists of two parts: 1) Part 1, a retrospective part, and 2) Part 2, a prospective part.
In Part 1, a retrospective cohort of 250 recipients of allo-HSCT at the Royal Melbourne Hospital will be reviewed. The study period will be between January 2012- December 2017, inclusive. The follow up period will be 6 months from the day of transplantation (ie. day 0 to 180). Data on patient demographics (age, sex, ethnicity), primary indication for transplantation, donor type (match, unmatched, minor mismatch, related or unrelated), graft source (stem cell, bone marrow, umbilical cord) conditioning regimen (myeloablative reduced intensity conditioning), graft versus host disease (GVHD) prophylaxis eg. T-cell depletion, days to neutrophil recovery, occurrence of acute and chronic GVHD and the therapy for GVHD (including steroid intensity, use of ATG etc.), associated bacterial and fungal infections, relapse and mortality, will be collected for analyses. CMV-negative patients will be used as control for economic comparisons.
In Part 2, 120 recipients of allo-HSCT will be recruited from 4 Australian hospitals (the Royal Melbourne Hospital, Austin Hospital, Peter MacCallum Cancer Centre, and Westmead Hospital). 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. In addition, participants who are at high risk of CMV will have study bloods taken to assess immune functions with Quantiferon-CMV®, Quantiferon-Monitor® assay, CMV Elispot, peripheral blood mononuclear cells (PBMCs) and plasma for storage at time-points of 0, 6 and 12 weeks +/- 2 weeks after commencing anti-CMV treatment. The Quantiferon-Monitor® assay will be performed at the additional time points of 4, 18 and 26 weeks following HSCT.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
No interventions assigned to this group
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
Blood sampling
Blood sampling from prospective study participants will be taken for immune functions measurements
Interventions
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Blood sampling
Blood sampling from prospective study participants will be taken for immune functions measurements
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* For the prospective cohort, patients who has CMV disease at the time of enrolment and patients who are unable to provide informed consent.
18 Years
ALL
No
Sponsors
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Peter MacCallum Cancer Centre, Australia
OTHER
Western Sydney Local Health District
OTHER
Walter and Eliza Hall Institute of Medical Research
OTHER
Austin Hospital, Melbourne Australia
OTHER
Melbourne Health
OTHER
Responsible Party
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Monica Slavin
Infectious Diseases Physician
Principal Investigators
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Monica Slavin, MBBS FRACP
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health
Locations
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Royal Melbourne Hospital
Parkville, Victoria, Australia
Countries
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Other Identifiers
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CReSCT
Identifier Type: -
Identifier Source: org_study_id
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