Cytomegalovirus (CMV) in allogeneic hematopoietic stem cell transplant patients
| ISRCTN | ISRCTN78128786 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78128786 |
| IRAS number | 287712 |
| Secondary identifying numbers | TAK620-5002, IRAS 287712, CPMS 46626 |
- Submission date
- 29/09/2021
- Registration date
- 25/11/2021
- Last edited
- 24/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Cytomegalovirus (CMV) is one of the most common infections that affects people with an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic stem cell transplantation involves transferring stem cells from a healthy person to the patient’s body after high-intensity chemotherapy or radiation. The aim of this study is to describe the treatment patterns and outcomes of CMV in about 400 HSCT recipients globally who required treatment for the management of CMV.
Who can participate?
Records from patients who were over 18 years old at the time of their HSCT and who were then treated for a CMV infection
What does the study involve?
The study will use the healthcare information that has already been documented from 1 January 2014 (until no later than determined at site level) related to the HSCT, CMV infections and outcomes including hospital visits, clinic visits, written follow-up notes, drug treatments, tests and procedures. This observational study uses records from routine healthcare, so the results of the study are not expected to be directly or immediately relevant to patient care and will not be shared with each participant.
What are the possible benefits and risks of participating?
This is a retrospective observational study so there are no physical risks that will result from taking part in this study. Taking part in this study has a very low risk of personally identifying information (PII) being accessed by unauthorized people (i.e., individuals who are not part of the study team). To reduce the risk of sharing PII with unauthorized persons, patient identifiers will be removed before being used in research so as to maintain confidentiality and privacy protection. It is expected there will be limited or no direct or immediate benefit to participants.
Where is the study run from?
Shire Human Genetic Therapies, Inc. a wholly-owned subsidiary of Takeda Pharmaceutical Company Ltd (USA)
When is the study starting and how long is it expected to run for?
May 2019 to December 2021
Who is funding the study?
Shire Human Genetic Therapies, Inc. a wholly-owned subsidiary of Takeda Pharmaceutical Company Ltd (USA)
Who is the main contact?
Ishan Hirji, Ishan.hirji@takeda.com
Contact information
Public
650 E. Kendall Street
Cambridge, MA
02142
United States of America
| Phone | +1 (0)6175888190 |
|---|---|
| ishan.hirji@takeda.com |
Scientific
650 E. Kendall Street
Cambridge, MA
02142
United States of America
| Phone | +1 (0)6175888190 |
|---|---|
| ishan.hirji@takeda.com |
Study information
| Study design | Multinational non-interventional retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Retrospective study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study following Hematopoietic Stem Cell Transplant (OTUS HSCT) |
| Study acronym | OTUS HSCT |
| Study hypothesis | Primary objective: To evaluate and describe the clinical outcomes with current management patterns Secondary objectives: 1. To describe the treatment patterns of cytomegalovirus (CMV) management 2. To describe the patient/clinical characteristics of Hematopoietic Stem Cell Transplant (HSCT) recipients 3. To describe the economic burden and healthcare resource utilization |
| Ethics approval(s) | Approved 11/12/2020, HRA and Health and Care Research Wales (Castlebridge 4, 15 - 19 Cowbridge Rd E, Cardiff, CF11 9AB, UK; +44 (0)2920 230457; HCRW.approvals@wales.nhs.uk); REC ref: 20/LO/1105 |
| Condition | Cytomegalovirus infection in transplanted patients |
| Intervention | The study will use the healthcare information that has already been documented from 1 January 2014 (until no later than determined at site level) related to the HSCT, CMV infections and outcomes including hospital visits, clinic visits, written follow-up notes, drug treatments, tests and procedures. This observational study uses records from routine healthcare. |
| Intervention type | Other |
| Primary outcome measure | 1. Number of CMV viremia episodes measured using patient records from transplant date until the end of follow-up 2. Time from HSCT to CMV viremia measured using patient records 3. Time to CMV viremia clearance measured using patient records 4. Incidence and time to CMV recurrence measured using patient records from CMV index episode until the end of follow-up 5. Incidence of tissue invasive disease measured using patient records from transplant date until the end of follow-up 6. Incidence of graft rejection measured using patient records from transplant date until the end of follow-up 7. Incidence of post-HSCT non-CMV infections requiring intravenous (IV) treatment or hospitalization, measured using patient records from transplant date to 365 days following the last PRRI CMV episode or until death (whichever occurs first) 8. Incidence of anti-CMV treatment-related myelosuppression, nephrotoxicity or other toxicities, measured using patient records from the first CMV episode until the end of follow-up 9. CMV resistance measured using patient records from the first CMV episode until the end of follow-up 10. CMV-associated mortality measured using patient records 11. All-cause mortality measured using patient records *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first. |
| Secondary outcome measures | 1. CMV prophylaxis and pre-emptive therapy, management of CMV reactivation/recurrence, measured from transplant date until the end of follow-up 2. Frequency of first-, second,- and third-line anti-CMV agents, measured using patient records from the first CMV episode until the end of follow-up 3. Time from HSCT to incident CMV-specific anti-viral therapy, measured using patient records 4. Viral load measured using patient records at transplant date and from 14 days prior to the start through the end of CMV episodes or until clearance 5. Medication utilization measured using patient records from transplant date until the end of follow-up 6. Demographics, diagnosis, transplant procedure, clinical, prior transplants, transplant indication, HCT comorbidity index comorbidities and score, prophylactic immunosuppressive regimen, measured using patient records at a pre-transplant time 7. Viral infections and prophylactic/treatment immunosuppressive regimen measured using patient records from transplant date until the end of follow-up 8. Viral infections, incidence and time to acute and chronic graft vs host disease (GVHD) and immunosuppressive regimen, measured using patient records from transplant date until the end of follow-up 9. Inpatient healthcare utilization, length of hospital stay, cause of hospitalization and number of outpatient clinic visits, measured using patient records from transplant date until the end of follow-up *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first. |
| Overall study start date | 20/05/2019 |
| Overall study end date | 06/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 379 |
| Participant inclusion criteria | Cohort 1: Resistant/refractory/intolerant inclusion criteria: 1. Aged ≥18 years at the time of the HSCT 2. Received an HSCT after 1 January 2014 3. Diagnosed with CMV infection any time after the HSCT date 4. Characterized as resistant to currently available treatments, OR refractory to currently available treatments, OR considered intolerant to currently available treatments 5. Follow-up data are available for at least 12 months (1 year) after being characterized in item (4) (above) or until death, whichever occurs first Cohort 2: Pre-emptive treatment for CMV viremia inclusion criteria: 1. Aged ≥18 years at the time of the HSCT 2. Received an HSCT after 1 January 2017 3. Diagnosed with CMV viremia any time after the HSCT date 4. Received pre-emptive treatment 5. Follow-up data are available for at least 12 months (1 year) after being characterized in item (4) (above) or until death, whichever occurs first |
| Participant exclusion criteria | Positive test for HIV before the HSCT |
| Recruitment start date | 16/10/2020 |
| Recruitment end date | 30/11/2021 |
Locations
Countries of recruitment
- England
- France
- Germany
- Italy
- Spain
- United Kingdom
- United States of America
- Wales
Study participating centres
United Kingdom
Spain
France
France
Italy
Germany
United Kingdom
United Kingdom
Spain
United States of America
United States of America
United States of America
United States of America
Germany
Germany
Sponsor information
Industry
Takeda Development Centers
95 Hayden Avenue
Lexington, MA
02421
United States of America
| Phone | +1 (0)617 953 7484 |
|---|---|
| polina.ioffe@takeda.com | |
| Website | https://www.takeda.com/ |
"ROR" |
https://ror.org/03bygaq51 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Takeda, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals America, Inc., Takeda in the U.S., TPUSA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study are intended to be disseminated through publication in peer-reviewed scientific journals and other publications (i.e. internal reports). The redacted study protocol and redacted statistical analysis plan will be made available. |
| IPD sharing plan | The datasets generated and/or analysed during the study will be made available upon request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | Text-based summary of results | 30/07/2023 | 24/08/2023 | No | No |
Additional files
- ISRCTN78128786_Other unpublished results_30Jul2023.pdf
- Text-based summary of results
Editorial Notes
24/08/2023: A text-based summary of results has been added.
25/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2021 to 06/12/2021.
2. The total final enrolment was added.
07/12/2021: Internal review.
27/10/2021: Trial's existence confirmed by the London - Surrey Research Ethics Committee.
