Skip to main content
MedPathMedPath Home
Clinical Trials/NCT06554197
NCT06554197
Recruiting
Not Applicable

Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation

The First Affiliated Hospital of Soochow University1 site in 1 country60 target enrollmentStarted: August 13, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHematopoietic Stem Cell TransplantationCytomegalovirus InfectionsEpstein-Barr Virus Infections

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
The First Affiliated Hospital of Soochow University
Enrollment
60
Locations
1
Primary Endpoint
CMV-CMI
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All patients were diagnosed with hemopathy.
  • •All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
  • •All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria

  • •Patients with any conditions not suitable for the trial (investigators' decision).

Outcomes

Primary Outcomes

CMV-CMI

Time Frame: 6 months after transplantation

CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT

EBV-CMI

Time Frame: 6 months after transplantation

EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT

Secondary Outcomes

  • Non-relapse mortality (NRM)(1 years after transplantation)
  • Overall survival (OS)(1 years after transplantation)
  • Cumulative incidence of CMV reactivation(1 years after transplantation)
  • Cumulative incidences of EBV reactivation(1 years after transplantation)
  • GVHD-free and relapse-free survival (GRFS)(1 years after transplantation)
  • Cumulative incidences of aGVHD(100 days after transplantation)
  • Relapse-related mortality (RRM)(1 years after transplantation)

Investigators

Sponsor
The First Affiliated Hospital of Soochow University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Phase 1
Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic InfectionsPathogen InfectionEBV InfectionCMV InfectionAdenovirus InfectionBKV InfectionFungus InfectionTuberculosis
NCT03159364Shenzhen Geno-Immune Medical Institute100
Completed
Not Applicable
PREDICT Cytomegalovirus (CMV)Lung Transplant
NCT03300882National Institute of Allergy and Infectious Diseases (NIAID)84
Recruiting
Not Applicable
Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant RecipientsLung Diseases
NCT06494033University of Miami100
Completed
Phase 2
Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe PneumoniaPneumoniaHIV/AIDSTuberculosisCytomegalovirus Infections
NCT03915366Hospital Universitario 12 de Octubre563
Recruiting
Phase 1
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed GlioblastomaGlioblastoma MultiformeAstrocytoma, Grade IV
NCT06157541Queensland Institute of Medical Research58