Clinical trial NCT05571137: A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada
Official title: A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Hematopoietic Stem Cell Transplant (HSCT) Recipients in Europe and Canada (OTUS HSCT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Netherlands, Poland and Serbia)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus (CMV)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who had a CMV infection treated with at least one anti-CMV agent and considered resistant, refractory, or intolerant to a currently available agent will be enrolled in Cohort 1 and participants who received pre-emptive therapy for CMV viremia will be enrolled in Cohort 2.

Brief summary: The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe \[EU\] and Canada \[CAN\]). Data will be collected retrospectively from medical charts.

No study medicines will be provided to participants in this study.

Detailed description: This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an HSCT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an HSCT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).

Eligibility criteria: Inclusion Criteria:

(Cohort 1) Resistant / Refractory or Intolerant:

* Aged greater than and equal to (\>=) 18 years at the time of the HSCT.
* Received an HSCT after January 1, 2016.
* Diagnosed with CMV infection any time after the HSCT date.
* Required \>=1 anti-CMV agent to manage CMV infection and were subsequently considered:

  1. resistant to currently available anti-CMV agent; OR
  2. refractory to currently available anti-CMV agent; OR
  3. intolerant to currently available anti-CMV agent.
* Follow-up information is available for at least 12 months from the index date (i.e., date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.
* Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by Institutional Ethical Committee \[IEC\]).

(Cohort 2) Pre-emptive treatment for CMV viremia:

* Aged \>=18 years at the time of the HSCT.
* Received an HSCT after January 1, 2019.
* Diagnosed with CMV viremia any time after the HSCT date and received pre-emptive anti-CMV agent.
* Follow-up information is available for at least 12 months from the index date (i.e., date when the patient was first preemptively treated with an anti-CMV agent) or death, whichever occurs first.
* Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by IEC).

Exclusion Criteria (both cohorts)

* Diagnosed as being positive for human immunodeficiency virus before the HSCT.
* Unable to demonstrate a minimum of 12 months of follow-up from the index date (e.g., incomplete information on dates showing follow-up time).
* Participation in a clinical trial related to CMV treatment during the study period.

Primary outcomes:
measure: Time From HSCT Until Start of Asymptomatic and Symptomatic Index Episode
timeFrame: From HSCT up to start date of the index episode (Up to 7 years 3 months)
measure: Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index and Recurrent Episodes
timeFrame: Up to 7 years 3 months
measure: Time From Start of Index Episode to CMV Viremia Clearance as Defined by Site Investigator
timeFrame: From start of index episode to CMV viremia clearance (Up to 7 years 3 months)
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 8 After Index Date
timeFrame: At Week 8 after index date
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
timeFrame: At Week 20 after index date
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at 1-year After Index Date
timeFrame: At 1-year after index date
measure: Percentage of Participants With Non-Detectable CMV During the Index Episode Prior to and After the Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Non-Detectable CMV at Week 8 After Index Date
timeFrame: At Week 8 after index date
measure: Percentage of Participants With Non-Detectable CMV at Week 20 After Index Date
timeFrame: At Week 20 after index date
measure: Percentage of Participants With Non-Detectable CMV at 1-year After Index Date
timeFrame: At 1-year after index date
measure: Time From Treatment Initiation to CMV Viremia Clearance as Defined by Site Investigator at the Index Episode
timeFrame: From Treatment Initiation to CMV Viremia Clearance (Up to 7 years 3 months)
measure: Time From Treatment Initiation Until Evidence of Non-detectable CMV at the Index Episode
timeFrame: Time from treatment initiation until evidence of non-detectable CMV (Up to 7 years 3 months)
measure: Time From Start of Index Episode to First Symptomatic CMV Diagnosis
timeFrame: From start of index episode to first symptomatic CMV diagnosis (Up to 7 years 3 months)
measure: Time From Stop Date of the Index Episode to First Recurrent Asymptomatic and Symptomatic CMV Viremia
timeFrame: From stop date of the index episode to first recurrent asymptomatic and symptomatic CMV viremia (Up to 7 years 3 months)
measure: Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Engraftment From HSCT
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Graft Versus Host Disease (GvHD) From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Graft Failure From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants who Died due to any Cause From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants who Died due to CMV Infection From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Number of Genetic Mutations Conferring Anti-CMV Resistance From HSCT and at Index Episode
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With a Genetic Mutation Conferring Anti-CMV Resistance From HSCT and at Index Episode
timeFrame: Up to 7 years 3 months
Secondary outcomes:
measure: Percentage of Participants With Anti-CMV Primary or Secondary Prophylaxis and Pre-emptive Treatment
timeFrame: Up to 7 years 3 months
measure: Number of Anti-CMV Therapies Used for Primary or Secondary Prophylaxis and Pre-emptive Treatment
timeFrame: Up to 7 years 3 months
measure: Duration of Anti-CMV Prophylaxis Therapy
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Mono-therapy and Dual-therapy of Anti-CMV Agents of Interest During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number of Individual and Dual-therapy of Anti-CMV Agents Used During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number With Individual and Dual Therapy of Anti-CMV Agents Used by Line of Treatment During Index Episode
timeFrame: Up to 7 years 3 months
measure: Duration of Anti-CMV Therapy During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number of Participants With Distribution of Switches of Anti-CMV Agents at the Index Date
timeFrame: Up to years 3 months
measure: Percentage of Participants Administered With First, Second, Third and Fourth Line of Anti-CMV Treatments From HSCT
timeFrame: Up to 7 years 3 months
measure: Time from HSCT to Administration of First-line Anti-CMV Agents of Interest and Between First-line Through the Fourth Line of Treatment
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on Reasons for Anti-CMV Dose Changes or Discontinuation for Anti-CMV Agents of Interest
timeFrame: Up to 7 years 3 months
measure: Number of Participants With Anti-CMV Agent Administered When Diagnosed With Myelosuppression and Nephrotoxicity
timeFrame: Up to 7 years 3 months
measure: Number of Participants Using Immunosuppressant From HSCT
timeFrame: Up to 7 years 3 months
measure: Number of Participants With CMV-related Outpatient Clinic Visits From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on Selected Procedures Performed at Outpatient Clinical Visits From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on CMV-related Hospitalizations and Emergency Department Visits From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Number of Participants Categorized Based on Reasons for CMV-related Hospitalization
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on Selected Procedures Performed at Hospitalizations and Emergency Department Visits From HSCT and Index Date
timeFrame: Up to 7 years 3 months
measure: Length of Hospital Stay for CMV-related Hospitalizations and Hospital Acquired CMV Viremia
timeFrame: Up to 7 years 3 months
measure: Duration of Stay in Critical Care and Non-critical Care
timeFrame: Up to 7 years 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MU Graz
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Athens
country: Greece
facility: Attikon General University Hospital
city: Thessaloniki
country: Greece
facility: George Papanikolau
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Warszawa
country: Poland
facility: Institute of Hematology and Transfusion Medicine (IHTM)
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: