Cytomegalovirus InfectionsNCT07688759
CMV-CMI in csCMVi After HSCT
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation (HSCT), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), Immune Reconstitution
- What is being tested?
- Anti-Cytomegalovirus Therapy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Aug 2028
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of CMV-seropositive adults (≥18 years of age) who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and experience their first CMV reactivation after transplantation.
Who may be able to join
- ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- First CMV reactivation after transplantation;
- Life expectancy of ≥8 weeks;
- The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.
Who cannot join
- Recurrence of CMV infection;
- primary CMV infection in CMV-seronegative recipients (R-);
- Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);
- Currently receiving CMV-CTL treatment or lymphocyte infusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The First Affiliated Hospital of Soochow University, +86 512 67972861, sdfyec@163.com
About this study
Official title: Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.
This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment.
The primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.
- Conditions
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), Immune Reconstitution
- Being tested
- Anti-Cytomegalovirus Therapy
- Keywords
- Cytomegalovirus, Hematopoietic Stem Cell Transplantation, Virus-specific T cells, cell-mediated immunity
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Cytomegalovirus TherapyDrug
The choice of agent (monotherapy or combination) is at the investigator's discretion and may include ganciclovir, valganciclovir, foscarnet, maribavir, or other approved anti-CMV medications.
| Study group | Role | What they receive |
|---|---|---|
| CMV Reactivation Cohort | Adult CMV-seropositive patients (≥18 years) who experience first CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Therapy with anti-CMV drugs (mono- or combination therapy, at investigator's discretion) is initiated upon diagnosis of CMV viremia and continued until two consecutive negative CMV DNA tests separated by ≥5 days. CMV-specific T cell levels are measured by ELISPOT at four time points: at CMV viremia diagnosis, 3 weeks after starting preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients are followed for 12 weeks after treatment cessation. Receives: Drug: Anti-Cytomegalovirus Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV-specific T cells
Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT
Measured: from baseline to 4 weeks after end of treatment, an average of 8 weeks
Secondary outcomes (5)
Cumulative incidence of refractory CMV infection
Measured: From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
Cumulative incidence of CMV disease
Measured: From EOT+1 day through 12 weeks after EOT(end of follow-up)
Cumulative incidence of recurrent CMV infection
Measured: From EOT+1 day through 12 weeks after EOT (end of follow-up)
Cumulative incidence of acute graft-versus-host disease (aGVHD)
Measured: From Day 1 through 12 weeks after EOT (end of follow-up)
Overall survival
Measured: From Day 1 through 12 weeks after EOT (end of follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688759
- Sponsor's protocol ID
- CMV-CMI in csCMVi
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) for the primary and secondary outcome measures will be made available upon reasonable request to the principal investigator. Data will be shared after publication of the primary study results, for research purposes only, under a data transfer agreement that ensures compliance with ethical and confidentiality requirements. Supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available as supplementary files.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- ClinicalTrials.gov ID
- NCT07688759
- Acronym / sponsor ID
- CMV-CMI in csCMVi
- Conditions
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), Immune Reconstitution
- Keywords
- Cytomegalovirus, Hematopoietic Stem Cell Transplantation, Virus-specific T cells, cell-mediated immunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Jul 2026 (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) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control.
This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment.
The primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV Reactivation Cohort | – | Drug: Anti-Cytomegalovirus TherapyAdult CMV-seropositive patients (≥18 years) who experience first CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Therapy with anti-CMV drugs (mono- or combination therapy, at investigator's discretion) is initiated upon diagnosis of CMV viremia and continued until two consecutive negative CMV DNA tests separated by ≥5 days. CMV-specific T cell levels are measured by ELISPOT at four time points: at CMV viremia diagnosis, 3 weeks after starting preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients are followed for 12 weeks after treatment cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of CMV-seropositive adults (≥18 years of age) who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and experience their first CMV reactivation after transplantation.
Key inclusion criteria (4 listed)
- ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- First CMV reactivation after transplantation;
- Life expectancy of ≥8 weeks;
- The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.
Key exclusion criteria (4 listed)
- Recurrence of CMV infection;
- primary CMV infection in CMV-seronegative recipients (R-);
- Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);
- Currently receiving CMV-CTL treatment or lymphocyte infusion.
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 |
|---|---|---|
| Anti-Cytomegalovirus TherapyThe choice of agent (monotherapy or combination) is at the investigator's discretion and may include ganciclovir, valganciclovir, foscarnet, maribavir, or other approved anti-CMV medications. | Drug | CMV Reactivation Cohort |
Primary outcome
CMV-specific T cells
Time frame: from baseline to 4 weeks after end of treatment, an average of 8 weeks
Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT
5 secondary outcomes
Cumulative incidence of refractory CMV infection
Time frame: From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
Cumulative incidence of CMV disease
Time frame: From EOT+1 day through 12 weeks after EOT(end of follow-up)
Cumulative incidence of recurrent CMV infection
Time frame: From EOT+1 day through 12 weeks after EOT (end of follow-up)
Cumulative incidence of acute graft-versus-host disease (aGVHD)
Time frame: From Day 1 through 12 weeks after EOT (end of follow-up)
Overall survival
Time frame: From Day 1 through 12 weeks after EOT (end of follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) for the primary and secondary outcome measures will be made available upon reasonable request to the principal investigator. Data will be shared after publication of the primary study results, for research purposes only, under a data transfer agreement that ensures compliance with ethical and confidentiality requirements. Supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available as supplementary files.
Related trials for Cytomegalovirus Infections
RecruitingPhase 2
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 1/2
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant
Cytomegaloviral Infection, Hematopoietic Cell Transplant Recipient
RecruitingEarly Phase 1
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Hematopoietic Stem Cell Transplantation (HSCT), run by The First Affiliated Hospital of Soochow University at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Chen, MD (+8613584861215, 13584861215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV-specific T cells (time frame: from baseline to 4 weeks after end of treatment, an average of 8 weeks). 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 7 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.