CMV InfectionNCT05656599
Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies
An observational study of CMV Infection and Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 2 sites in China.
Trial summary
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CMV Infection, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Letermovir
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult patients who received allogeneic HSCT.
Who may be able to join
- Be receiving a first allogeneic HSCT.
- Is male or female, from 14 years to any years of age inclusive.
- The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.
Who cannot join
- Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
- Has a history of CMV end-organ disease within 6 months prior to allocation.
- Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
- Any rapidly-progressing disease or immediately life-threatening illness.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
People's Hospital of Peking University
Beijing
About this study
Official title: Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
Read the detailed description
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.
Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
- Being tested
- Letermovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Patients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes
| Study group | Role | What they receive |
|---|---|---|
| Letermovir Group | HSCT recipients who received letermovir prophylaxis Receives: Drug: Letermovir | |
| Preemptive therapy Group | HSCT recipients who received PCR-guided preemptive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant CMV infection (CSI)
Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease.
Measured: 6 months after HSCT
Incidence of refractory CMV infection and CMV disease
Refractory CMV infection is defined as a persistent viral load (CMV viral load at the same level or higher than the peak viral load within 1 week but <1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay) after at least 2 weeks of appropriately dosed antiviral therapy.
Measured: 6 months after HSCT
Numbers of immune cells in peripheral blood
PBMCs from HSCT recipients were collected at 1 month, 2 month, 3 month, and 6 month after HSCT, and tested for NK cells, T cells, CMV-specific T cells and their subsets.
Measured: 6 months after HSCT
Secondary outcomes (3)
Treatment-ralated mortality
Treatment-ralated mortality
Measured: Through study completion, an average of 1 year
Overall survival
Overall survival
Measured: Through study completion, an average of 1 year
Incidence of other viral infection and viral-associated disease
Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV
Measured: 6 months after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start3 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656599
- Sponsor's protocol ID
- 2021PHB423-001
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies
- ClinicalTrials.gov ID
- NCT05656599
- Acronym / sponsor ID
- 2021PHB423-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
Detailed description
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.
Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letermovir Group | – | Drug: LetermovirHSCT recipients who received letermovir prophylaxis |
| Preemptive therapy Group | – | –HSCT recipients who received PCR-guided preemptive therapy |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients who received allogeneic HSCT.
Key inclusion criteria (3 listed)
- Be receiving a first allogeneic HSCT.
- Is male or female, from 14 years to any years of age inclusive.
- The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.
Key exclusion criteria (4 listed)
- Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
- Has a history of CMV end-organ disease within 6 months prior to allocation.
- Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
- Any rapidly-progressing disease or immediately life-threatening illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirPatients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes | Drug | Letermovir Group |
Primary outcome
Incidence of clinically significant CMV infection (CSI)
Time frame: 6 months after HSCT
Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease.
Incidence of refractory CMV infection and CMV disease
Time frame: 6 months after HSCT
Refractory CMV infection is defined as a persistent viral load (CMV viral load at the same level or higher than the peak viral load within 1 week but <1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay) after at least 2 weeks of appropriately dosed antiviral therapy.
Numbers of immune cells in peripheral blood
Time frame: 6 months after HSCT
PBMCs from HSCT recipients were collected at 1 month, 2 month, 3 month, and 6 month after HSCT, and tested for NK cells, T cells, CMV-specific T cells and their subsets.
3 secondary outcomes
Treatment-ralated mortality
Time frame: Through study completion, an average of 1 year
Overall survival
Time frame: Through study completion, an average of 1 year
Incidence of other viral infection and viral-associated disease
Time frame: 6 months after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Infection and Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant CMV infection (CSI) (time frame: 6 months after HSCT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.