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NCT Number: NCT07688759

CMV-CMI in csCMVi After 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location status: Recruiting

Location contact

The First Affiliated Hospital of Soochow University

CONTACT

[email protected]

+86 512 67972861

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Cumulative incidence of refractory CMV infection

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

  2. Cumulative incidence of CMV disease

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

  3. Cumulative incidence of recurrent CMV infection

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

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

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

  5. Overall survival

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

Other outcomes

  1. Cumulative incidence of non-relapse mortality (NRM)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Chen, MD

CONTACT

[email protected]

+8613584861215

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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