EBV-associated T/NK-cell Lymphoproliferative DiseasesNCT07488728
Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
A study testing Letermovir in people with EBV-associated T/NK-cell Lymphoproliferative Diseases and Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis, run by Beijing Children's Hospital at 1 site in China.
Trial summary
This study investigates the impact of letermovir prophylaxis on viral infections (including CMV, EBV, BKV, HHV-6/7, RSV, ADV, HSV, etc.) following allogeneic hematopoietic stem cell transplantation in pediatric patients with EBV-associated T/NK-cell lymphoproliferative diseases and refractory/relapsed EBV-related… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- EBV-associated T/NK-cell Lymphoproliferative Diseases, Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis, Letermovir
- What is being tested?
- Letermovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with EBV-positive T/NK lymphoproliferative disease (EBV-T/NK LPD) according to ICC 2022 criteria, or diagnosed with refractory/relapsed EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) according to the 2004-HLH diagnostic criteria;
- Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the study center;
- Age < 18 years;
- CMV seropositive (IgG+) prior to transplantation;
- Presence of at least one high-risk factor for CMV infection: haploidentical transplantation, HLA-mismatched transplantation, receipt of ATG (including ATLG/ALG) in conditioning, sustained corticosteroid use post-conditioning, donor/recipient CMV serostatus mismatch, or positive NGS result pre-transplant.
Who cannot join
- History of CMV end-organ disease within 6 months prior to enrollment;
- Severe hepatic dysfunction (defined as Child-Pugh Class C);
- End-stage renal impairment with creatinine clearance < 10 mL/min (calculated by Cockcroft-Gault equation);
- Prior allogeneic hematopoietic stem cell transplantation;
- Expected survival ≤ 3 months;
- Received radiation therapy during conditioning;
Show all 9Show fewer
- Initiation of letermovir prophylaxis after day 28 post-transplant;
- Letermovir dosage or administration not in accordance with the prescribing information;
- Lack of signed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100032
Jun Yang, +86 13699293825, yangjundabby@outlook.com
About this study
Official title: Impact of Letermovir Prophylaxis on Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
This study investigates the impact of letermovir prophylaxis on viral infections (including CMV, EBV, BKV, HHV-6/7, RSV, ADV, HSV, etc.) following allogeneic hematopoietic stem cell transplantation in pediatric patients with EBV-associated T/NK-cell lymphoproliferative diseases and refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis. Additionally, we examine its effects on other transplantation complications, including engraftment failure, graft-versus-host disease (GvHD), disease relapse, thrombotic microangiopathy (TMA), overall survival (OS), post-transplant lymphoproliferative disorder (PTLD) incidence, and immune reconstitution.
- Conditions
- EBV-associated T/NK-cell Lymphoproliferative Diseases, Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis, Letermovir
- Being tested
- Letermovir
- Keywords
- EBV, Letermovir, EBV-associated T/NK-cell lymphoproliferative diseases, refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Arm 1 (Letermovir Prophylaxis): Pediatric patients receive oral letermovir once daily from day 0 to day 100 post-transplant. Prophylaxis may be extended to day 200 if high-risk factors persist (steroid use, poor immune reconstitution). Dosing: 480mg (≥30kg), 240mg (15-30kg), 120mg (7.5-15kg), 80mg (6-7.5kg); halved if co-administered with cyclosporine.
Arm 2 (Control): Historical control cohort (2018-2023) receiving no routine CMV prophylaxis; preemptive therapy with ganciclovir/foscarnet initiated only when plasma PCR exceeds threshold.
| Study group | Role | What they receive |
|---|---|---|
| Children with Letermovir for Cytomegalovirus prophylaxis after HSCT | Experimental | Not described Receives: Drug: Letermovir |
| Children with preemptive therapy, without Letermovir for Cytomegalovirus prophylaxis after HSCT | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi)
To evaluate the incidence of clinically significant CMV and EBV infections in pediatric patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with or without letermovir prophylaxis.
Measured: Up to 180 days and 360 days post-transplant
Secondary outcomes (1)
Incidence of Other Viral Infections and Transplant-Related Complications
To assess the incidence of other viral infections (e.g., BKV, HHV-6/7, RSV, ADV, HSV), graft-versus-host disease (GvHD), post-transplant lymphoproliferative disorder (PTLD), thrombotic microangiopathy (TMA), graft failure, relapse, overall survival (OS), and immune reconstitution (T/B/NK cell counts and function).
Measured: Up to 100, 180, 270, and 360 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV-associated T/NK-cell Lymphoproliferative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Yang, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488728
- Sponsor's protocol ID
- [2025]-Y-242-D
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Letermovir Prophylaxis on Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
- ClinicalTrials.gov ID
- NCT07488728
- Acronym / sponsor ID
- [2025]-Y-242-D
- Conditions
- EBV-associated T/NK-cell Lymphoproliferative Diseases, Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis, Letermovir
- Keywords
- EBV, Letermovir, EBV-associated T/NK-cell lymphoproliferative diseases, refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the impact of letermovir prophylaxis on viral infections (including CMV, EBV, BKV, HHV-6/7, RSV, ADV, HSV, etc.) following allogeneic hematopoietic stem cell transplantation in pediatric patients with EBV-associated T/NK-cell lymphoproliferative diseases and refractory/relapsed EBV-related hemophagocytic lymphohistiocytosis. Additionally, we examine its effects on other transplantation complications, including engraftment failure, graft-versus-host disease (GvHD), disease relapse, thrombotic microangiopathy (TMA), overall survival (OS), post-transplant lymphoproliferative disorder (PTLD) incidence, and immune reconstitution.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Letermovir for Cytomegalovirus prophylaxis after HSCT | Experimental | Drug: Letermovir |
| Children with preemptive therapy, without Letermovir for Cytomegalovirus prophylaxis after HSCT | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with EBV-positive T/NK lymphoproliferative disease (EBV-T/NK LPD) according to ICC 2022 criteria, or diagnosed with refractory/relapsed EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) according to the 2004-HLH diagnostic criteria;
- Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the study center;
- Age < 18 years;
- CMV seropositive (IgG+) prior to transplantation;
- Presence of at least one high-risk factor for CMV infection: haploidentical transplantation, HLA-mismatched transplantation, receipt of ATG (including ATLG/ALG) in conditioning, sustained corticosteroid use post-conditioning, donor/recipient CMV serostatus mismatch, or positive NGS result pre-transplant.
Key exclusion criteria (9 listed)
- History of CMV end-organ disease within 6 months prior to enrollment;
- Severe hepatic dysfunction (defined as Child-Pugh Class C);
- End-stage renal impairment with creatinine clearance < 10 mL/min (calculated by Cockcroft-Gault equation);
- Prior allogeneic hematopoietic stem cell transplantation;
- Expected survival ≤ 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirArm 1 (Letermovir Prophylaxis): Pediatric patients receive oral letermovir once daily from day 0 to day 100 post-transplant. Prophylaxis may be extended to day 200 if high-risk factors persist (steroid use, poor immune reconstitution). Dosing: 480mg (≥30kg), 240mg (15-30kg), 120mg (7.5-15kg), 80mg (6-7.5kg); halved if co-administered with cyclosporine. Arm 2 (Control): Historical control cohort (2018-2023) receiving no routine CMV prophylaxis; preemptive therapy with ganciclovir/foscarnet initiated only when plasma PCR exceeds threshold. | Drug | Children with Letermovir for Cytomegalovirus prophylaxis after HSCT |
Primary outcome
Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi)
Time frame: Up to 180 days and 360 days post-transplant
To evaluate the incidence of clinically significant CMV and EBV infections in pediatric patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with or without letermovir prophylaxis.
1 secondary outcome
Incidence of Other Viral Infections and Transplant-Related Complications
Time frame: Up to 100, 180, 270, and 360 days post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Related trials for EBV-associated T/NK-cell Lymphoproliferative Diseases
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
Active, not recruitingPhase 1
CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene
Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
RecruitingObservational study
Registry of Older Patients With Cancer
Chronic Myeloproliferative Disorders, Cognitive/Functional Effects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letermovir in people with EBV-associated T/NK-cell Lymphoproliferative Diseases and Refractory/Relapsed EBV-related Hemophagocytic Lymphohistiocytosis, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Yang, Doctor (+86 13699293825, yangjundabby@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant CMV Infection (cs-CMVi) and EBV Infection (cs-EBVi) (time frame: Up to 180 days and 360 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.