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New treatment option for EBV-associated T/NK-cell Lymphoproliferative Diseases
Official title Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-Associated Hemophagocytic Lymphohistiocytosis
ClinicalTrials.gov ID: NCT07488728
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ebv-associated t/nk-cell lymphoproliferative diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Diagnosed with EBV-positive T/NK lymphoproliferative disease (EBV-T/NK LPD) according to ICC 2022 criteria, or diagnosed with refractory/relapsed...
- 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...
You likely can't join if
- 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;
See the full eligibility criteria
- 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...
- 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...
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.