Clinical trial · Interventional
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After All-HSCT
CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
NCT06449586CI-TRIAL-00098980active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letermovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CMI-F
- description
- Letemovir prophylaxis stops when CMV-FlowSpot \>1.5.
- interventionNames
- Drug: Letermovir
- type
- OTHER
- label
- CMI-N
- description
- Letemovir prophylaxis stopos in the first 100 days after allo-HSCT.
- interventionNames
- Drug: Letermovir
Primary outcomes (1)
- measure
- Incidence of late-onset clinical significant CMV (cs-CMV) infection
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * first allogeneic hematopoietic stem cell transplantation; * 18-70 years old; * use cytomegalovirus prophylaxis with letemovir after allo-HSCT; * CMV Ig G D+/R+; Exclusion Criteria: * Allergy, known hypersensitivity to letermovir tablet or injection components; * CMV DNAemia within six months before transplantation or previous CMV disease; * Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation; * Second transplantation; * Combination of immunodeficiency diseases; * Those judged by the investigator to be unsuitable for participation in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.