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Trial Title:
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT
NCT ID:
NCT06449586
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Letermovir
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Letermovir
Description:
letermovir stops when CMI>1.5
Arm group label:
CMI-F
Arm group label:
CMI-N
Summary:
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of
letermovir for avoiding late-onset csCMVi after all-HSCT.
Detailed description:
Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality
following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir
(LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi)
in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has
been reported to increase the risk of late-onset csCMVi, causing by impaired
reconstitution of CMV-specific T immunity. The investigator sought to decrease the
probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells
is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir
has been found impending recovery of CMV-specific T immunity. The investigators'
retrospective study has proved that lower CMV-specific CD4+ T cells (<2.01 cells/µL) at
week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher
ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell
immunity is recommended in letermovir prophylaxis.
Therefore, the investigator conduct a multicenter, randomized, controlled study based on
retrospective research to further explore and validate the efficacy of CMV-specific T
cell immunity test guiding the prolonged usage of letermovir.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. , first allogeneic hematopoietic stem cell transplantation;
2. , 18-70 years old;
3. , use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
4. , CMV Ig G D+/R+;
Exclusion Criteria:
1. , Allergy, known hypersensitivity to letermovir tablet or injection components;
2. , CMV DNAemia within six months before transplantation or previous CMV disease;
3. , Presence of organ failure and inability to tolerate allogeneic hematopoietic stem
cell transplantation;
4. , Second transplantation;
5. , Combination of immunodeficiency diseases;
6. , Those judged by the investigator to be unsuitable for participation in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449586
