Evaluation of CMV/EBV-CMI in Haploid HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CMV/EBV-CMI.
- Who it may be relevant to
- Registry conditions: Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections, Epstein-Barr Virus Infections. Basic parameters: 16 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
Overview
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) .
Interventions
- Diagnostic test CMV/EBV-CMI
The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
Primary outcome measures
- CMV-CMI [Time frame: 6 months after transplantation]
- EBV-CMI [Time frame: 6 months after transplantation]
Secondary outcome measures (7)
- Cumulative incidence of CMV reactivation [Time frame: 1 years after transplantation]
- Cumulative incidences of EBV reactivation [Time frame: 1 years after transplantation]
- Overall survival (OS) [Time frame: 1 years after transplantation]
- Non-relapse mortality (NRM) [Time frame: 1 years after transplantation]
- Relapse-related mortality (RRM) [Time frame: 1 years after transplantation]
- GVHD-free and relapse-free survival (GRFS) [Time frame: 1 years after transplantation]
- Cumulative incidences of aGVHD [Time frame: 100 days after transplantation]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT06554197 · CMV/EBV-CMI