CMV-CMI in csCMVi After HSCT

NCT07688759 | Recruiting DMC

• 1 other identifier: CMV-CMI in csCMVi
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Cytomegalovirus; Hematopoietic Stem Cell Transplantation; Virus-specific T cells; cell-mediated immunity

Outcome Measures

Primary Outcomes (1)

• CMV-specific T cells

  Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT

  from baseline to 4 weeks after end of treatment, an average of 8 weeks

Secondary Outcomes (5)

• Cumulative incidence of refractory CMV infection

  From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks

• Cumulative incidence of CMV disease

  From EOT+1 day through 12 weeks after EOT(end of follow-up)

• Cumulative incidence of recurrent CMV infection

  From EOT+1 day through 12 weeks after EOT (end of follow-up)

• Cumulative incidence of acute graft-versus-host disease (aGVHD)

  From Day 1 through 12 weeks after EOT (end of follow-up)

• Overall survival

  From Day 1 through 12 weeks after EOT (end of follow-up).

Other Outcomes (1)

• Cumulative incidence of non-relapse mortality (NRM)

  From Day 1 through 12 weeks after EOT (end of follow-up).

Study Arms (1)

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.

Drug: Anti-Cytomegalovirus Therapy

Interventions

Anti-Cytomegalovirus Therapy DRUG

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.

CMV Reactivation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Feng Chen, MD

CONTACT

+8613584861215; 13584861215@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)