Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449586
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-01
Brief Title:
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 201 cellsµL at week 8 increased the risk of late-onset CMV reactivation 500 compared to the higher ones 769 p004 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None